From Staff Reports

Draft Guidance Given on Disclosures

The Food and Drug Administration has released draft guidance designed to provide more information on conflicts of interest involving members of its advisory committees and the waivers that allow them to participate in specific meetings.

The draft guidance is designed to bring agency policy in line with standard conflict of interest practice in the academic community, where medical journals require disclosures to be specific and thorough, the FDA said in a press briefing.

The FDA has 49 advisory committees with a total of more than 600 positions. Federal law allows the FDA to grant waivers so that experts who have conflicts of interest can participate in advisory committee meetings.

When a waiver is granted, federal law requires the FDA to disclose the type, nature, and magnitude of the conflict on its Web site. The law limits the number of waivers to about 13% of all meeting participants, and in practice the agency grants waivers to fewer than 5%.

Under the draft guidance, the agency would expand the information disclosed about waivers so that the nature of the waiver granted and name of the company or institution involved also would be posted online prior to committee meetings.

Public comment will be accepted through June 20.

Infusion Pumps to Be Regulated

The FDA will regulate the design and manufacture of infusion pumps in the wake of thousands of adverse event reports, the agency announced.

Over the past 5 years the FDA has received more than 56,000 reports of adverse events, including more than 500 deaths, related to the pumps.

During that period there have been 87 recalls of infusion pumps undertaken to address identified safety concerns. The problems have ranged from manufacturing defects to software bugs to user error.

The FDA is taking several steps to address the devices' problems at the level of manufacture.

In the interim, the agency is advising clinicians to use several strategies to reduce risk when using infusion pumps: Have a plan in place to respond to pump failures; prevent errors by labeling infusion pump channels and tubing; check settings of infusion pumps; check patients for signs of under- or overinfusion; and promptly report adverse events to the FDA.

The FDA has also ordered Baxter, the manufacturer of Colleague Volumetric Infusion pumps, to recall and destroy all of these pumps currently in use in the United States, because of a “longstanding failure to correct many serious problems” with the pumps.

The FDA said that hospitals and other users of these Colleague pumps will be receiving more information from Baxter and the FDA about making the transition to other infusion devices.

GnRH Agonists Get Safety Study

The FDA is investigating whether treatment with a gonadotropin-releasing hormone agonist increases the risk of diabetes and cardiovascular events in men with prostate cancer.

In a statement issued May 3, the agency said that a preliminary analysis of several studies has identified an association between the use of gonadotropin-releasing hormone (GnRH) agonists and a “small increased risk” for diabetes, MI, stroke, and sudden death. The FDA has not made any conclusions about whether diabetes or these cardiovascular diseases are caused by treatment with these drugs, which are available in generic formulations and as brand-name products (Lupron, Eligard, Synarel, Trelstar, Vantas, Viadur, and Zoladex).

The studies under review are published observational studies and one randomized controlled clinical trial that compared androgen deprivation therapy using a GnRH agonist with other treatments in men with prostate cancer.

At this time, the FDA is advising that health care professionals should be aware of these potential risks “and carefully weigh the benefits and risks of GnRH agonists when determining a treatment for patients with prostate cancer,” and that they should monitor patients for diabetes and cardiovascular disease when treated with one of these drugs.

These drugs are also used in women (for endometriosis-related pain, anemia associated with uterine fibroids before a hysterectomy, and palliative treatment for advanced breast cancer), but “there are no known studies that have evaluated the risk of diabetes and heart disease” in women taking these drugs, according to the FDA.

Cancer Linked With Parkinson's Rx

An excess number of prostate cancer cases among men treated with the Parkinson's disease product that contains entacapone, carbidopa, and levodopa in a controlled clinical trial has prompted an FDA review of the combination drug's safety.

The agency is evaluating data from the Stalevo Reduction in Dyskinesia Evaluation–Parkinson's Disease (STRIDE-PD) study, which found that over a mean of almost 3 years, the number of prostate cancers diagnosed among the men treated with entacapone, carbidopa, and levodopa (marketed as Stalevo) was about four times higher than the cases diagnosed among those treated with the carbidopa and levodopa combination product (marketed as Sinemet). The FDA has not concluded that Stalevo increases the risk of prostate cancer.

“Healthcare professionals should be aware of this possible risk and follow current guidelines for prostate cancer screening” in patients on this combination product, and patients should not stop taking their medication unless directed to do so, the statement added.

Warning Added to Thyroid Drug Label

Severe liver injuries have been associated with use of the antithyroid drug propylthiouracil, and the FDA has added a boxed warning to the product's label conveying this risk, the agency announced.

The warning for propylthiouracil (PTU) says that there have been reports of severe liver injury and acute liver failure, including fatalities, in those treated with the drug. Additionally, the agency said, for patients who are beginning treatment for hyperthyroidism, “it may be appropriate to reserve use of propylthiouracil for those who cannot tolerate other treatments such as methimazole, radioactive iodine, or surgery.”

PTU was approved in 1947 for the treatment of hyperthyroidism.

The warning also notes that because birth defects have been associated with use of the antithyroid drug methimazole during the first trimester, “propylthiouracil may be the treatment of choice during and just before the first trimester of pregnancy.”

The FDA issued a warning to health care professionals about PTU's hepatoxicity in June 2009 and has added the boxed warning as part of the Risk Evaluation and Mitigation Strategy (REMS) for the drug.

There were 34 cases of severe liver injury associated with PTU reported between 1969 and 2009. The FDA is requiring a boxed warning because of the severity of these cases “and to ensure that healthcare professionals are aware of this risk and are vigilant for the signs and symptoms of hepatic toxicity,” the statement added.

Rules for Home Use Strengthened

Citing reports of injuries and deaths associated with home use of medical devices that may not have been intended for use in that environment, the FDA announced that it will enhance its regulation of such products.

The agency aims to have a final policy in place within a year. Devices targeted by this initiative include cardiac monitors, ventilators, infusion pumps, dialysis machines, and wound-care products.

The FDA receives about 1,500 reports of adverse events occurring in homes each year. It is not clear how many of those are related to home use of medical devices; however, the agency has become increasingly concerned based on the trend toward early hospital discharge as well as aging of the population.

Among the types of events reported were ventilator failure because a caregiver did not hear an alarm; cat dander clogging a dialysis machine; and video-game interference causing the malfunction of implantable cardioverter defibrillators.

About 8 million people receive home care each year from 17,000 paid providers, at a cost of about $57 billion. Those figures don't account for people who receive care from family members.

The FDA will establish a multipronged approach to ensuring that manufacturers, home health agencies, patients, and caregivers have the information needed to reduce the risk of malfunctions, injuries, and deaths.

Draft Guidance Given on Disclosures

The Food and Drug Administration has released draft guidance designed to provide more information on conflicts of interest involving members of its advisory committees and the waivers that allow them to participate in specific meetings.

The draft guidance is designed to bring agency policy in line with standard conflict of interest practice in the academic community, where medical journals require disclosures to be specific and thorough, the FDA said in a press briefing.

The FDA has 49 advisory committees with a total of more than 600 positions. Federal law allows the FDA to grant waivers so that experts who have conflicts of interest can participate in advisory committee meetings.

When a waiver is granted, federal law requires the FDA to disclose the type, nature, and magnitude of the conflict on its Web site. The law limits the number of waivers to about 13% of all meeting participants, and in practice the agency grants waivers to fewer than 5%.

Under the draft guidance, the agency would expand the information disclosed about waivers so that the nature of the waiver granted and name of the company or institution involved also would be posted online prior to committee meetings.

Public comment will be accepted through June 20.

Infusion Pumps to Be Regulated

The FDA will regulate the design and manufacture of infusion pumps in the wake of thousands of adverse event reports, the agency announced.

Over the past 5 years the FDA has received more than 56,000 reports of adverse events, including more than 500 deaths, related to the pumps.

During that period there have been 87 recalls of infusion pumps undertaken to address identified safety concerns. The problems have ranged from manufacturing defects to software bugs to user error.

The FDA is taking several steps to address the devices' problems at the level of manufacture.

In the interim, the agency is advising clinicians to use several strategies to reduce risk when using infusion pumps: Have a plan in place to respond to pump failures; prevent errors by labeling infusion pump channels and tubing; check settings of infusion pumps; check patients for signs of under- or overinfusion; and promptly report adverse events to the FDA.

The FDA has also ordered Baxter, the manufacturer of Colleague Volumetric Infusion pumps, to recall and destroy all of these pumps currently in use in the United States, because of a “longstanding failure to correct many serious problems” with the pumps.

The FDA said that hospitals and other users of these Colleague pumps will be receiving more information from Baxter and the FDA about making the transition to other infusion devices.

GnRH Agonists Get Safety Study

The FDA is investigating whether treatment with a gonadotropin-releasing hormone agonist increases the risk of diabetes and cardiovascular events in men with prostate cancer.

In a statement issued May 3, the agency said that a preliminary analysis of several studies has identified an association between the use of gonadotropin-releasing hormone (GnRH) agonists and a “small increased risk” for diabetes, MI, stroke, and sudden death. The FDA has not made any conclusions about whether diabetes or these cardiovascular diseases are caused by treatment with these drugs, which are available in generic formulations and as brand-name products (Lupron, Eligard, Synarel, Trelstar, Vantas, Viadur, and Zoladex).

The studies under review are published observational studies and one randomized controlled clinical trial that compared androgen deprivation therapy using a GnRH agonist with other treatments in men with prostate cancer.

At this time, the FDA is advising that health care professionals should be aware of these potential risks “and carefully weigh the benefits and risks of GnRH agonists when determining a treatment for patients with prostate cancer,” and that they should monitor patients for diabetes and cardiovascular disease when treated with one of these drugs.

These drugs are also used in women (for endometriosis-related pain, anemia associated with uterine fibroids before a hysterectomy, and palliative treatment for advanced breast cancer), but “there are no known studies that have evaluated the risk of diabetes and heart disease” in women taking these drugs, according to the FDA.

Cancer Linked With Parkinson's Rx

An excess number of prostate cancer cases among men treated with the Parkinson's disease product that contains entacapone, carbidopa, and levodopa in a controlled clinical trial has prompted an FDA review of the combination drug's safety.

The agency is evaluating data from the Stalevo Reduction in Dyskinesia Evaluation–Parkinson's Disease (STRIDE-PD) study, which found that over a mean of almost 3 years, the number of prostate cancers diagnosed among the men treated with entacapone, carbidopa, and levodopa (marketed as Stalevo) was about four times higher than the cases diagnosed among those treated with the carbidopa and levodopa combination product (marketed as Sinemet). The FDA has not concluded that Stalevo increases the risk of prostate cancer.

“Healthcare professionals should be aware of this possible risk and follow current guidelines for prostate cancer screening” in patients on this combination product, and patients should not stop taking their medication unless directed to do so, the statement added.

Warning Added to Thyroid Drug Label

Severe liver injuries have been associated with use of the antithyroid drug propylthiouracil, and the FDA has added a boxed warning to the product's label conveying this risk, the agency announced.

The warning for propylthiouracil (PTU) says that there have been reports of severe liver injury and acute liver failure, including fatalities, in those treated with the drug. Additionally, the agency said, for patients who are beginning treatment for hyperthyroidism, “it may be appropriate to reserve use of propylthiouracil for those who cannot tolerate other treatments such as methimazole, radioactive iodine, or surgery.”

PTU was approved in 1947 for the treatment of hyperthyroidism.

The warning also notes that because birth defects have been associated with use of the antithyroid drug methimazole during the first trimester, “propylthiouracil may be the treatment of choice during and just before the first trimester of pregnancy.”

The FDA issued a warning to health care professionals about PTU's hepatoxicity in June 2009 and has added the boxed warning as part of the Risk Evaluation and Mitigation Strategy (REMS) for the drug.

There were 34 cases of severe liver injury associated with PTU reported between 1969 and 2009. The FDA is requiring a boxed warning because of the severity of these cases “and to ensure that healthcare professionals are aware of this risk and are vigilant for the signs and symptoms of hepatic toxicity,” the statement added.

Rules for Home Use Strengthened

Citing reports of injuries and deaths associated with home use of medical devices that may not have been intended for use in that environment, the FDA announced that it will enhance its regulation of such products.

The agency aims to have a final policy in place within a year. Devices targeted by this initiative include cardiac monitors, ventilators, infusion pumps, dialysis machines, and wound-care products.

The FDA receives about 1,500 reports of adverse events occurring in homes each year. It is not clear how many of those are related to home use of medical devices; however, the agency has become increasingly concerned based on the trend toward early hospital discharge as well as aging of the population.

Among the types of events reported were ventilator failure because a caregiver did not hear an alarm; cat dander clogging a dialysis machine; and video-game interference causing the malfunction of implantable cardioverter defibrillators.

About 8 million people receive home care each year from 17,000 paid providers, at a cost of about $57 billion. Those figures don't account for people who receive care from family members.

The FDA will establish a multipronged approach to ensuring that manufacturers, home health agencies, patients, and caregivers have the information needed to reduce the risk of malfunctions, injuries, and deaths.

Draft Guidance Given on Disclosures

The Food and Drug Administration has released draft guidance designed to provide more information on conflicts of interest involving members of its advisory committees and the waivers that allow them to participate in specific meetings.

The draft guidance is designed to bring agency policy in line with standard conflict of interest practice in the academic community, where medical journals require disclosures to be specific and thorough, the FDA said in a press briefing.

The FDA has 49 advisory committees with a total of more than 600 positions. Federal law allows the FDA to grant waivers so that experts who have conflicts of interest can participate in advisory committee meetings.

When a waiver is granted, federal law requires the FDA to disclose the type, nature, and magnitude of the conflict on its Web site. The law limits the number of waivers to about 13% of all meeting participants, and in practice the agency grants waivers to fewer than 5%.

Under the draft guidance, the agency would expand the information disclosed about waivers so that the nature of the waiver granted and name of the company or institution involved also would be posted online prior to committee meetings.

Public comment will be accepted through June 20.

Infusion Pumps to Be Regulated

The FDA will regulate the design and manufacture of infusion pumps in the wake of thousands of adverse event reports, the agency announced.

Over the past 5 years the FDA has received more than 56,000 reports of adverse events, including more than 500 deaths, related to the pumps.

During that period there have been 87 recalls of infusion pumps undertaken to address identified safety concerns. The problems have ranged from manufacturing defects to software bugs to user error.

The FDA is taking several steps to address the devices' problems at the level of manufacture.

In the interim, the agency is advising clinicians to use several strategies to reduce risk when using infusion pumps: Have a plan in place to respond to pump failures; prevent errors by labeling infusion pump channels and tubing; check settings of infusion pumps; check patients for signs of under- or overinfusion; and promptly report adverse events to the FDA.

The FDA has also ordered Baxter, the manufacturer of Colleague Volumetric Infusion pumps, to recall and destroy all of these pumps currently in use in the United States, because of a “longstanding failure to correct many serious problems” with the pumps.

The FDA said that hospitals and other users of these Colleague pumps will be receiving more information from Baxter and the FDA about making the transition to other infusion devices.

GnRH Agonists Get Safety Study

The FDA is investigating whether treatment with a gonadotropin-releasing hormone agonist increases the risk of diabetes and cardiovascular events in men with prostate cancer.

In a statement issued May 3, the agency said that a preliminary analysis of several studies has identified an association between the use of gonadotropin-releasing hormone (GnRH) agonists and a “small increased risk” for diabetes, MI, stroke, and sudden death. The FDA has not made any conclusions about whether diabetes or these cardiovascular diseases are caused by treatment with these drugs, which are available in generic formulations and as brand-name products (Lupron, Eligard, Synarel, Trelstar, Vantas, Viadur, and Zoladex).

The studies under review are published observational studies and one randomized controlled clinical trial that compared androgen deprivation therapy using a GnRH agonist with other treatments in men with prostate cancer.

At this time, the FDA is advising that health care professionals should be aware of these potential risks “and carefully weigh the benefits and risks of GnRH agonists when determining a treatment for patients with prostate cancer,” and that they should monitor patients for diabetes and cardiovascular disease when treated with one of these drugs.

These drugs are also used in women (for endometriosis-related pain, anemia associated with uterine fibroids before a hysterectomy, and palliative treatment for advanced breast cancer), but “there are no known studies that have evaluated the risk of diabetes and heart disease” in women taking these drugs, according to the FDA.

Cancer Linked With Parkinson's Rx

An excess number of prostate cancer cases among men treated with the Parkinson's disease product that contains entacapone, carbidopa, and levodopa in a controlled clinical trial has prompted an FDA review of the combination drug's safety.

The agency is evaluating data from the Stalevo Reduction in Dyskinesia Evaluation–Parkinson's Disease (STRIDE-PD) study, which found that over a mean of almost 3 years, the number of prostate cancers diagnosed among the men treated with entacapone, carbidopa, and levodopa (marketed as Stalevo) was about four times higher than the cases diagnosed among those treated with the carbidopa and levodopa combination product (marketed as Sinemet). The FDA has not concluded that Stalevo increases the risk of prostate cancer.

“Healthcare professionals should be aware of this possible risk and follow current guidelines for prostate cancer screening” in patients on this combination product, and patients should not stop taking their medication unless directed to do so, the statement added.

Warning Added to Thyroid Drug Label

Severe liver injuries have been associated with use of the antithyroid drug propylthiouracil, and the FDA has added a boxed warning to the product's label conveying this risk, the agency announced.

The warning for propylthiouracil (PTU) says that there have been reports of severe liver injury and acute liver failure, including fatalities, in those treated with the drug. Additionally, the agency said, for patients who are beginning treatment for hyperthyroidism, “it may be appropriate to reserve use of propylthiouracil for those who cannot tolerate other treatments such as methimazole, radioactive iodine, or surgery.”

PTU was approved in 1947 for the treatment of hyperthyroidism.

The warning also notes that because birth defects have been associated with use of the antithyroid drug methimazole during the first trimester, “propylthiouracil may be the treatment of choice during and just before the first trimester of pregnancy.”

The FDA issued a warning to health care professionals about PTU's hepatoxicity in June 2009 and has added the boxed warning as part of the Risk Evaluation and Mitigation Strategy (REMS) for the drug.

There were 34 cases of severe liver injury associated with PTU reported between 1969 and 2009. The FDA is requiring a boxed warning because of the severity of these cases “and to ensure that healthcare professionals are aware of this risk and are vigilant for the signs and symptoms of hepatic toxicity,” the statement added.

Rules for Home Use Strengthened

Citing reports of injuries and deaths associated with home use of medical devices that may not have been intended for use in that environment, the FDA announced that it will enhance its regulation of such products.

The agency aims to have a final policy in place within a year. Devices targeted by this initiative include cardiac monitors, ventilators, infusion pumps, dialysis machines, and wound-care products.

The FDA receives about 1,500 reports of adverse events occurring in homes each year. It is not clear how many of those are related to home use of medical devices; however, the agency has become increasingly concerned based on the trend toward early hospital discharge as well as aging of the population.

Among the types of events reported were ventilator failure because a caregiver did not hear an alarm; cat dander clogging a dialysis machine; and video-game interference causing the malfunction of implantable cardioverter defibrillators.

About 8 million people receive home care each year from 17,000 paid providers, at a cost of about $57 billion. Those figures don't account for people who receive care from family members.

The FDA will establish a multipronged approach to ensuring that manufacturers, home health agencies, patients, and caregivers have the information needed to reduce the risk of malfunctions, injuries, and deaths.

Sanofi Seals Deal for Monitors

Sanofi-Aventis will codevelop blood glucose monitoring devices with the French pharmaceutical company AgaMatrix in a deal that could provide leverage to Sanofi if it pursues agreements with larger partners in the diabetes arena, said David Kliff, founder of the Web site Diabetic Investor. AgaMatrix will develop a portfolio of glucose monitors exclusively for Sanofi, benefiting in return from Sanofi's global brands and marketing reach. Sanofi executives predicted that the addition of blood glucose monitors and insulin pumps would give the company's diabetes business a competitive edge. Lantus, Sanofi's long-acting insulin, brought in $4.6 billion in sales last year, and Apidra, its short-acting insulin, yielded $185 million. Providing a system connecting pharma products, devices, and patient education “is the way diabetes management is going,” Mr. Kliff said.

Forest Labs, Phenomix Split

Forest Laboratories Inc. of New York has ended its agreement with Phenomix Corp. in San Diego to develop and market dutogliptin for type 2 diabetes. Forest canceled the agreement “for business reasons,” according to its quarterly earnings report. The $340 million deal, initiated in the fall of 2008, provided Phenomix $75 million up front and split the development and commercialization costs between the two companies. Phenomix' phase III trial demonstrated that dutogliptin met its primary goal of lowering hemoglobin A_1c levels. “We are disappointed that on the heels of such positive data that we will not be moving forward with our collaboration with Forest,” said Laura Shawver, Phenomix's chief executive officer.

Alimera Misses IPO Target

Alimera Sciences, which is developing drugs for ophthalmic diseases, raised $72 million at $11 a share in its IPO last month. The company had targeted a $96 million IPO with shares priced at $15–$17, but incurred 2009 operating expenses of $19 million and debt of nearly $48 million. Some of the funds will be used to pay debts to pSivida, an Australian company that acquired Control Delivery Systems, which had partnered with Alimera to develop Iluvien for diabetic macular edema. Alimera also will spend about $13.4 million to finish phase III trials of the drug. If the drug gains Food and Drug Administration approval, Alimera will have to make a $25 million milestone payment to pSivida. Based in Alpharetta, Ga., Alimera had raised $88.6 million as of July 2008 in previous funding rounds. “If we are not successful in commercializing Iluvien … our business will be materially harmed and we may need to curtail or cease operations,” the company reported in a filing.

Charles River Nabs Chinese Firm

Charles River Laboratories International, based in Wilmington, Mass., will buy WuXi PharmaTech of Shanghai, China, for $1.6 billion. The proposed combination would allow drug developers to conduct preclinical studies in the United States, Europe, and China. The acquisition, through a combined cash and stock transaction, would provide a premium of at least 28% to the closing price of WuXi's stock on the New York Stock Exchange as of April 23, according to executives at both companies. “Outsourcing seems to be an inexorable trend,” said Ge Li, WuXi's founder and CEO. James Foster, CEO of Charles River, agreed, citing lower costs and the availability of trained scientists in China. The merger, subject to approval by China's Ministry of Commerce and by shareholders, is expected to be completed by year's end.

Merck Names New President

Merck has named Ken Frazier as its new president, replacing Dick Clark, who will remain as CEO and chairman. Mr. Frazier had served as Merck's president of global human health after serving as the company's general counsel for 8 years. He led the implementation of “important improvements in the efficiency and effectiveness of the worldwide sales and marketing organization” while maintaining sales momentum, according to a company statement. Under his leadership, Merck launched a new commercial model in the United States and in key markets in Europe, Latin America, and Asia Pacific; improved the division structure; and expanded the company's reach in emerging markets, the statement noted. As part of a restructuring program to reduce costs by $3 billion, the company plans to reduce its workforce by 15% by 2012.

Reporters and editors from Elsevier's “The Pink Sheet” contributed to this column.

Sanofi Seals Deal for Monitors

Sanofi-Aventis will codevelop blood glucose monitoring devices with the French pharmaceutical company AgaMatrix in a deal that could provide leverage to Sanofi if it pursues agreements with larger partners in the diabetes arena, said David Kliff, founder of the Web site Diabetic Investor. AgaMatrix will develop a portfolio of glucose monitors exclusively for Sanofi, benefiting in return from Sanofi's global brands and marketing reach. Sanofi executives predicted that the addition of blood glucose monitors and insulin pumps would give the company's diabetes business a competitive edge. Lantus, Sanofi's long-acting insulin, brought in $4.6 billion in sales last year, and Apidra, its short-acting insulin, yielded $185 million. Providing a system connecting pharma products, devices, and patient education “is the way diabetes management is going,” Mr. Kliff said.

Forest Labs, Phenomix Split

Forest Laboratories Inc. of New York has ended its agreement with Phenomix Corp. in San Diego to develop and market dutogliptin for type 2 diabetes. Forest canceled the agreement “for business reasons,” according to its quarterly earnings report. The $340 million deal, initiated in the fall of 2008, provided Phenomix $75 million up front and split the development and commercialization costs between the two companies. Phenomix' phase III trial demonstrated that dutogliptin met its primary goal of lowering hemoglobin A_1c levels. “We are disappointed that on the heels of such positive data that we will not be moving forward with our collaboration with Forest,” said Laura Shawver, Phenomix's chief executive officer.

Alimera Misses IPO Target

Alimera Sciences, which is developing drugs for ophthalmic diseases, raised $72 million at $11 a share in its IPO last month. The company had targeted a $96 million IPO with shares priced at $15–$17, but incurred 2009 operating expenses of $19 million and debt of nearly $48 million. Some of the funds will be used to pay debts to pSivida, an Australian company that acquired Control Delivery Systems, which had partnered with Alimera to develop Iluvien for diabetic macular edema. Alimera also will spend about $13.4 million to finish phase III trials of the drug. If the drug gains Food and Drug Administration approval, Alimera will have to make a $25 million milestone payment to pSivida. Based in Alpharetta, Ga., Alimera had raised $88.6 million as of July 2008 in previous funding rounds. “If we are not successful in commercializing Iluvien … our business will be materially harmed and we may need to curtail or cease operations,” the company reported in a filing.

Charles River Nabs Chinese Firm

Charles River Laboratories International, based in Wilmington, Mass., will buy WuXi PharmaTech of Shanghai, China, for $1.6 billion. The proposed combination would allow drug developers to conduct preclinical studies in the United States, Europe, and China. The acquisition, through a combined cash and stock transaction, would provide a premium of at least 28% to the closing price of WuXi's stock on the New York Stock Exchange as of April 23, according to executives at both companies. “Outsourcing seems to be an inexorable trend,” said Ge Li, WuXi's founder and CEO. James Foster, CEO of Charles River, agreed, citing lower costs and the availability of trained scientists in China. The merger, subject to approval by China's Ministry of Commerce and by shareholders, is expected to be completed by year's end.

Merck Names New President

Merck has named Ken Frazier as its new president, replacing Dick Clark, who will remain as CEO and chairman. Mr. Frazier had served as Merck's president of global human health after serving as the company's general counsel for 8 years. He led the implementation of “important improvements in the efficiency and effectiveness of the worldwide sales and marketing organization” while maintaining sales momentum, according to a company statement. Under his leadership, Merck launched a new commercial model in the United States and in key markets in Europe, Latin America, and Asia Pacific; improved the division structure; and expanded the company's reach in emerging markets, the statement noted. As part of a restructuring program to reduce costs by $3 billion, the company plans to reduce its workforce by 15% by 2012.

Reporters and editors from Elsevier's “The Pink Sheet” contributed to this column.

Sanofi Seals Deal for Monitors

Sanofi-Aventis will codevelop blood glucose monitoring devices with the French pharmaceutical company AgaMatrix in a deal that could provide leverage to Sanofi if it pursues agreements with larger partners in the diabetes arena, said David Kliff, founder of the Web site Diabetic Investor. AgaMatrix will develop a portfolio of glucose monitors exclusively for Sanofi, benefiting in return from Sanofi's global brands and marketing reach. Sanofi executives predicted that the addition of blood glucose monitors and insulin pumps would give the company's diabetes business a competitive edge. Lantus, Sanofi's long-acting insulin, brought in $4.6 billion in sales last year, and Apidra, its short-acting insulin, yielded $185 million. Providing a system connecting pharma products, devices, and patient education “is the way diabetes management is going,” Mr. Kliff said.

Forest Labs, Phenomix Split

Forest Laboratories Inc. of New York has ended its agreement with Phenomix Corp. in San Diego to develop and market dutogliptin for type 2 diabetes. Forest canceled the agreement “for business reasons,” according to its quarterly earnings report. The $340 million deal, initiated in the fall of 2008, provided Phenomix $75 million up front and split the development and commercialization costs between the two companies. Phenomix' phase III trial demonstrated that dutogliptin met its primary goal of lowering hemoglobin A_1c levels. “We are disappointed that on the heels of such positive data that we will not be moving forward with our collaboration with Forest,” said Laura Shawver, Phenomix's chief executive officer.

Alimera Misses IPO Target

Alimera Sciences, which is developing drugs for ophthalmic diseases, raised $72 million at $11 a share in its IPO last month. The company had targeted a $96 million IPO with shares priced at $15–$17, but incurred 2009 operating expenses of $19 million and debt of nearly $48 million. Some of the funds will be used to pay debts to pSivida, an Australian company that acquired Control Delivery Systems, which had partnered with Alimera to develop Iluvien for diabetic macular edema. Alimera also will spend about $13.4 million to finish phase III trials of the drug. If the drug gains Food and Drug Administration approval, Alimera will have to make a $25 million milestone payment to pSivida. Based in Alpharetta, Ga., Alimera had raised $88.6 million as of July 2008 in previous funding rounds. “If we are not successful in commercializing Iluvien … our business will be materially harmed and we may need to curtail or cease operations,” the company reported in a filing.

Charles River Nabs Chinese Firm

Charles River Laboratories International, based in Wilmington, Mass., will buy WuXi PharmaTech of Shanghai, China, for $1.6 billion. The proposed combination would allow drug developers to conduct preclinical studies in the United States, Europe, and China. The acquisition, through a combined cash and stock transaction, would provide a premium of at least 28% to the closing price of WuXi's stock on the New York Stock Exchange as of April 23, according to executives at both companies. “Outsourcing seems to be an inexorable trend,” said Ge Li, WuXi's founder and CEO. James Foster, CEO of Charles River, agreed, citing lower costs and the availability of trained scientists in China. The merger, subject to approval by China's Ministry of Commerce and by shareholders, is expected to be completed by year's end.

Merck Names New President

Merck has named Ken Frazier as its new president, replacing Dick Clark, who will remain as CEO and chairman. Mr. Frazier had served as Merck's president of global human health after serving as the company's general counsel for 8 years. He led the implementation of “important improvements in the efficiency and effectiveness of the worldwide sales and marketing organization” while maintaining sales momentum, according to a company statement. Under his leadership, Merck launched a new commercial model in the United States and in key markets in Europe, Latin America, and Asia Pacific; improved the division structure; and expanded the company's reach in emerging markets, the statement noted. As part of a restructuring program to reduce costs by $3 billion, the company plans to reduce its workforce by 15% by 2012.

Reporters and editors from Elsevier's “The Pink Sheet” contributed to this column.

New Form of OxyContin Okayed

A new formulation of OxyContin has been approved by the Food and Drug Administration in an effort to curb abuse of the widely prescribed pain-relief opioid medication.

OxyContin will be reformulated into tablets that are harder to cut, crush, break, chew, or dissolve, the FDA said. Abusers commonly break down the pills so that more of the active ingredient oxycodone is released when the drug is snorted or injected into the bloodstream, the FDA explained a written statement. The reformulation was approved April 5.

The new tablet is harder to crack, and “attempts to dissolve the tablets in liquid result in a gummy substance that cannot be drawn up into a syringe or injected,” the FDA said.

The FDA is requiring the manufacturer of OxyContin, Purdue Pharma, to conduct a postmarketing study on the extent to which the new formulation actually reduces abuse of the drug.

Varicose Vein Treatment Gets Nod

Polidocanol injection was approved March 31 for treatment of varicose veins, the FDA said.

Distributed by BioFarm Medical as Asclera, polidocanol is approved to treat small spider and reticular veins up to 3 mm in diameter. The injectable agent improves the appearance of varicose veins by damaging the cell lining of the blood vessels, thus causing vessels to close and be replaced by less-visible types of tissue. Varicose veins affect half of people age 50 years and older.

Common adverse reactions to polidocanol include pain or hematoma at the injection site, bruising, irritation, and discoloration, the FDA said.

Rozerem Claims Draw Rebuke

Takeda Pharmaceuticals misrepresents its sleep aid Rozerem (ramelteon) in sales materials aimed at physicians who treat substance abusers by claiming the product has “no likelihood of abuse and no detectable toxicity,” the FDA's Division of Drug Marketing, Advertising, and Communications has charged.

In a letter to Takeda's North American division, the DDMAC requested that the drug maker immediately cease dissemination of the materials.

Rozerem was approved in 2005 for use by patients whose insomnia is characterized by trouble falling asleep. It is not a controlled substance, as are competitors in the sedative-hypnotics class, but that difference alone does not “confer added safety,” the DDMAC said. The FDA is particularly concerned with a bar graph in the materials that compares Rozerem with 18 hypnotic drugs on “likelihood of abuse” and “toxicity” scores, with Rozerem scoring zero. However, Rozerem is associated with “numerous risks, including potential endocrine toxicity,” regulators asserted.

More Data Sought on Menthol

The tobacco industry is being asked for data about menthol cigarettes so that the FDA can determine whether the additive should be restricted or banned, agency advisers said March 31.

The FDA's new Tobacco Products Scientific Advisory Committee wants to know how the industry manufactures menthol, how and why it is added to cigarettes, and how manufacturers decide when to increase or decrease menthol levels. The committee also wants to know what the substance does in the body—including chemosensory, neurologic, and behavioral effects—and how and why menthol is marketed to certain population groups.

A number of health organizations have asked for menthol to be banned, including the American Medical Association, the American Public Health Association, the American Heart Association, and the Legacy Foundation.

The Tobacco Products Scientific Advisory Committee met for the first time since the FDA was given the power in June 2009 to regulate tobacco through the Family Smoking Prevention and Tobacco Control Act.

First Anti-Acne Lotion Approved

The first retinoid lotion for the treatment of acne vulgaris has received approval, the manufacturer announced on March 22.

Differin Lotion 0.1% (adapalene) will be available by prescription in April for treating acne on the face and body of patients aged 12 years and older.

The approval comes after positive results were seen in two similarly designed 12-week, multicenter, controlled clinical studies comparing Differin 0.1% (Galderma) to a vehicle in 2,141 acne patients.

In both studies, Differin 0.1% was shown to significantly reduce inflammatory lesions. Dryness was the most commonly reported side effect, occurring in about 7% of patients during the first 2 weeks of treatment and decreasing thereafter.

Benzoyl Peroxide Declared Safe

After 2 decades of debate, the FDA has issued a final rule declaring benzoyl peroxide to be safe and effective as an ingredient in over-the-counter topical acne products.

According to agency policy, benzoyl peroxide is now GRASE (generally recognized as safe and effective). In 1991, the FDA proposed to classify the agent as a category III agent, which meant that it needed more study. At that time, some data suggested that benzoyl peroxide was potentially carcinogenic in animals.

Subsequently, new data have allayed the agency's concerns. “We now conclude that benzoyl peroxide can be adequately labeled to minimize the risks,” the FDA noted in its final rule. The new labeling will include warnings to avoid unnecessary sun exposure and wear sunscreen, to not use the product on very sensitive skin, and to keep the product away from the eyes, lips, and mouth.

New Form of OxyContin Okayed

A new formulation of OxyContin has been approved by the Food and Drug Administration in an effort to curb abuse of the widely prescribed pain-relief opioid medication.

OxyContin will be reformulated into tablets that are harder to cut, crush, break, chew, or dissolve, the FDA said. Abusers commonly break down the pills so that more of the active ingredient oxycodone is released when the drug is snorted or injected into the bloodstream, the FDA explained a written statement. The reformulation was approved April 5.

The new tablet is harder to crack, and “attempts to dissolve the tablets in liquid result in a gummy substance that cannot be drawn up into a syringe or injected,” the FDA said.

The FDA is requiring the manufacturer of OxyContin, Purdue Pharma, to conduct a postmarketing study on the extent to which the new formulation actually reduces abuse of the drug.

Varicose Vein Treatment Gets Nod

Polidocanol injection was approved March 31 for treatment of varicose veins, the FDA said.

Distributed by BioFarm Medical as Asclera, polidocanol is approved to treat small spider and reticular veins up to 3 mm in diameter. The injectable agent improves the appearance of varicose veins by damaging the cell lining of the blood vessels, thus causing vessels to close and be replaced by less-visible types of tissue. Varicose veins affect half of people age 50 years and older.

Common adverse reactions to polidocanol include pain or hematoma at the injection site, bruising, irritation, and discoloration, the FDA said.

Rozerem Claims Draw Rebuke

Takeda Pharmaceuticals misrepresents its sleep aid Rozerem (ramelteon) in sales materials aimed at physicians who treat substance abusers by claiming the product has “no likelihood of abuse and no detectable toxicity,” the FDA's Division of Drug Marketing, Advertising, and Communications has charged.

In a letter to Takeda's North American division, the DDMAC requested that the drug maker immediately cease dissemination of the materials.

Rozerem was approved in 2005 for use by patients whose insomnia is characterized by trouble falling asleep. It is not a controlled substance, as are competitors in the sedative-hypnotics class, but that difference alone does not “confer added safety,” the DDMAC said. The FDA is particularly concerned with a bar graph in the materials that compares Rozerem with 18 hypnotic drugs on “likelihood of abuse” and “toxicity” scores, with Rozerem scoring zero. However, Rozerem is associated with “numerous risks, including potential endocrine toxicity,” regulators asserted.

More Data Sought on Menthol

The tobacco industry is being asked for data about menthol cigarettes so that the FDA can determine whether the additive should be restricted or banned, agency advisers said March 31.

The FDA's new Tobacco Products Scientific Advisory Committee wants to know how the industry manufactures menthol, how and why it is added to cigarettes, and how manufacturers decide when to increase or decrease menthol levels. The committee also wants to know what the substance does in the body—including chemosensory, neurologic, and behavioral effects—and how and why menthol is marketed to certain population groups.

A number of health organizations have asked for menthol to be banned, including the American Medical Association, the American Public Health Association, the American Heart Association, and the Legacy Foundation.

The Tobacco Products Scientific Advisory Committee met for the first time since the FDA was given the power in June 2009 to regulate tobacco through the Family Smoking Prevention and Tobacco Control Act.

First Anti-Acne Lotion Approved

The first retinoid lotion for the treatment of acne vulgaris has received approval, the manufacturer announced on March 22.

Differin Lotion 0.1% (adapalene) will be available by prescription in April for treating acne on the face and body of patients aged 12 years and older.

The approval comes after positive results were seen in two similarly designed 12-week, multicenter, controlled clinical studies comparing Differin 0.1% (Galderma) to a vehicle in 2,141 acne patients.

In both studies, Differin 0.1% was shown to significantly reduce inflammatory lesions. Dryness was the most commonly reported side effect, occurring in about 7% of patients during the first 2 weeks of treatment and decreasing thereafter.

Benzoyl Peroxide Declared Safe

After 2 decades of debate, the FDA has issued a final rule declaring benzoyl peroxide to be safe and effective as an ingredient in over-the-counter topical acne products.

According to agency policy, benzoyl peroxide is now GRASE (generally recognized as safe and effective). In 1991, the FDA proposed to classify the agent as a category III agent, which meant that it needed more study. At that time, some data suggested that benzoyl peroxide was potentially carcinogenic in animals.

Subsequently, new data have allayed the agency's concerns. “We now conclude that benzoyl peroxide can be adequately labeled to minimize the risks,” the FDA noted in its final rule. The new labeling will include warnings to avoid unnecessary sun exposure and wear sunscreen, to not use the product on very sensitive skin, and to keep the product away from the eyes, lips, and mouth.

New Form of OxyContin Okayed

A new formulation of OxyContin has been approved by the Food and Drug Administration in an effort to curb abuse of the widely prescribed pain-relief opioid medication.

OxyContin will be reformulated into tablets that are harder to cut, crush, break, chew, or dissolve, the FDA said. Abusers commonly break down the pills so that more of the active ingredient oxycodone is released when the drug is snorted or injected into the bloodstream, the FDA explained a written statement. The reformulation was approved April 5.

The new tablet is harder to crack, and “attempts to dissolve the tablets in liquid result in a gummy substance that cannot be drawn up into a syringe or injected,” the FDA said.

The FDA is requiring the manufacturer of OxyContin, Purdue Pharma, to conduct a postmarketing study on the extent to which the new formulation actually reduces abuse of the drug.

Varicose Vein Treatment Gets Nod

Polidocanol injection was approved March 31 for treatment of varicose veins, the FDA said.

Distributed by BioFarm Medical as Asclera, polidocanol is approved to treat small spider and reticular veins up to 3 mm in diameter. The injectable agent improves the appearance of varicose veins by damaging the cell lining of the blood vessels, thus causing vessels to close and be replaced by less-visible types of tissue. Varicose veins affect half of people age 50 years and older.

Common adverse reactions to polidocanol include pain or hematoma at the injection site, bruising, irritation, and discoloration, the FDA said.

Rozerem Claims Draw Rebuke

Takeda Pharmaceuticals misrepresents its sleep aid Rozerem (ramelteon) in sales materials aimed at physicians who treat substance abusers by claiming the product has “no likelihood of abuse and no detectable toxicity,” the FDA's Division of Drug Marketing, Advertising, and Communications has charged.

In a letter to Takeda's North American division, the DDMAC requested that the drug maker immediately cease dissemination of the materials.

Rozerem was approved in 2005 for use by patients whose insomnia is characterized by trouble falling asleep. It is not a controlled substance, as are competitors in the sedative-hypnotics class, but that difference alone does not “confer added safety,” the DDMAC said. The FDA is particularly concerned with a bar graph in the materials that compares Rozerem with 18 hypnotic drugs on “likelihood of abuse” and “toxicity” scores, with Rozerem scoring zero. However, Rozerem is associated with “numerous risks, including potential endocrine toxicity,” regulators asserted.

More Data Sought on Menthol

The tobacco industry is being asked for data about menthol cigarettes so that the FDA can determine whether the additive should be restricted or banned, agency advisers said March 31.

The FDA's new Tobacco Products Scientific Advisory Committee wants to know how the industry manufactures menthol, how and why it is added to cigarettes, and how manufacturers decide when to increase or decrease menthol levels. The committee also wants to know what the substance does in the body—including chemosensory, neurologic, and behavioral effects—and how and why menthol is marketed to certain population groups.

A number of health organizations have asked for menthol to be banned, including the American Medical Association, the American Public Health Association, the American Heart Association, and the Legacy Foundation.

The Tobacco Products Scientific Advisory Committee met for the first time since the FDA was given the power in June 2009 to regulate tobacco through the Family Smoking Prevention and Tobacco Control Act.

First Anti-Acne Lotion Approved

The first retinoid lotion for the treatment of acne vulgaris has received approval, the manufacturer announced on March 22.

Differin Lotion 0.1% (adapalene) will be available by prescription in April for treating acne on the face and body of patients aged 12 years and older.

The approval comes after positive results were seen in two similarly designed 12-week, multicenter, controlled clinical studies comparing Differin 0.1% (Galderma) to a vehicle in 2,141 acne patients.

In both studies, Differin 0.1% was shown to significantly reduce inflammatory lesions. Dryness was the most commonly reported side effect, occurring in about 7% of patients during the first 2 weeks of treatment and decreasing thereafter.

Benzoyl Peroxide Declared Safe

After 2 decades of debate, the FDA has issued a final rule declaring benzoyl peroxide to be safe and effective as an ingredient in over-the-counter topical acne products.

According to agency policy, benzoyl peroxide is now GRASE (generally recognized as safe and effective). In 1991, the FDA proposed to classify the agent as a category III agent, which meant that it needed more study. At that time, some data suggested that benzoyl peroxide was potentially carcinogenic in animals.

Subsequently, new data have allayed the agency's concerns. “We now conclude that benzoyl peroxide can be adequately labeled to minimize the risks,” the FDA noted in its final rule. The new labeling will include warnings to avoid unnecessary sun exposure and wear sunscreen, to not use the product on very sensitive skin, and to keep the product away from the eyes, lips, and mouth.

Baxter Acquires ApaTech

Baxter International Inc. will enter the bone fusion market through its acquisition of ApaTech, maker of the bone graft Actifuse, for up to $330 million, in a deal announced last month. Baxter will pay $240 million up front, plus up to $90 million in milestone payments. The total is worth up to 5.5 times ApaTech's sales of $60 million last year. Actifuse “will allow us to immediately enter the emerging bone fusion category, and ApaTech's product pipeline is highly complementary to our existing commercial and technical capabilities in biosurgery,” said Ron Lloyd, vice president and general manager of Baxter's BioTherapeutics and Regenerative Medicine. Actifuse is a silicate-substituted, calcium-phosphate synthetic bone graft material that combines a biostimulative scaffold with chemical properties that accelerate bone formation, according to ApaTech. Actifuse formulations include microgranules for small graft areas and E-Z Prep, which forms a cohesive graft in 20 minutes when mixed with blood or bone marrow aspirate. According to Andrew Lewis, a spokesperson for Baxter, the overall U.S. bone growth substitutes market is worth $1.5 billion, and the synthetic bone growth substitutes segment reached $145 million in 2009. The deal also will allow Baxter to gain access to ApaTech's global sales force, half of which is based in the United States.

Envoy, Merck Team for Research

Envoy Therapeutics Inc. has entered into a multiyear research collaboration agreement with an affiliate of Merck and Co. to explore novel diabetes and obesity drug targets. Envoy will use its bacTRAP technology to identify proteins expressed specifically in certain cell types, and Merck, which will provide an upfront fee and research funding, will develop compounds that modulate protein targets with therapeutic potential for the treatment of metabolic disorders. “Obesity and diabetes have become epidemics with horrific mortality rates and devastating social stigmas,” said Brad Margus, cofounder and CEO of Envoy. “We're thrilled that our technology will be applied toward discovering drug candidates for the growing millions of patients who suffer from these conditions.” Envoy will be eligible to receive payments at certain milestones associated with drug candidate development and royalties on any products resulting from the collaboration. “Partnering with companies developing innovative drug discovery technologies … is an essential part of our diabetes and obesity portfolio discovery strategy,” said Nancy A. Thornberry, senior vice president and franchise head for diabetes and obesity at Merck Research Laboratories.

Atherotech Taps Heart Experts

Atherotech Inc., maker of the VAP cholesterol test, which identifies markers for the metabolic syndrome, has added eight cardiovascular experts to its medical advisory board to guide the development of the company's disease management program. The new team comprises Dr. Eliot A. Brintman, director of the metabolism section of cardiovascular genetics and the LDL apheresis center at the University of Utah, Salt Lake City; Dr. Michael H. Davidson, director of preventive cardiology at the University of Chicago; Prakash C. Deedwania, chief of cardiology for the VA Central California HealthCare System, Fresno; Dr. Gary H. Gibbons, endowed director of Morehouse School of Medicine's Cardiovascular Research Institute, Atlanta; Dr. Peter H. Jones, medical director of the Methodist Weight Management Center in Houston; Dr. Richard B. Lanman, chief medical officer of Veracyte Inc., a molecular diagnostics company in South San Francisco, Calif.; Dr. Charles A. Reasner II, medical director of the Texas Diabetes Institute in San Antonio; and Dr. Peter B. Toth, chief of medicine at CGH Medical Center in Sterling, Ill. “Collectively, [they] have more than 150 years of clinical research, nearly 1,000 publications, and over 200 years of clinical patient care,” said Dr. Michael E. Cobble, Atherotech's chief medical officer. In addition to the VAP cholesterol test, Atherotech has more than a dozen cardiovascular and metabolic tests, including those for high-sensitivity C-reactive protein, lipoprotein-associated phospholipase A2, apoE genotype, N-terminal–pro brain natriuretic peptide, cystatin C, T3 and T4, and gamma-glutamyl transferase.

Unigene Restructures to Meet Debts

Unigene Laboratories, maker of Fortical, a nasal calcitonin treatment for postmenopausal osteoporosis, has restructured its debt financing agreement with Victory Park Capital Advisors, its primary shareholder and lender. The deal buys time for Unigene to pay off its debt and adds $13.6 million to its balance sheet. The family-owned biopharmaceutical company agreed to major management change and gave Victory two seats, including chairmanship, on its board of directors. Unigene's chairman, Jay Levy, relinquished his board seat and Ronald S. Levy, secretary, left that position but stayed on as executive vice president, according to the terms of the agreement filed with the Securities and Exchange Commission. The regulatory filing also states that Unigene “is obligated to use its reasonable best efforts to identify, interview, and negotiate with candidates for, and, subject to the board's approval, hire a new chief executive officer as successor to Warren Levy as soon as reasonably practicable.” Victory Park Capital's principal and founder, Richard N. Levy (no relation to the Levy family that runs Unigene), stepped in as chairman. Unigene reported a 2009 net loss of $13.4 million, more than double its 2008 net loss of $6.1 million. Unigene is currently focused on the development of salmon calcitonin in nasal and oral formulations for postmenopausal osteoporosis, Paget's disease, and hypercalcemia.

Reporters and editors from Elsevier's “The Pink Sheet” contributed to this column.

Baxter Acquires ApaTech

Baxter International Inc. will enter the bone fusion market through its acquisition of ApaTech, maker of the bone graft Actifuse, for up to $330 million, in a deal announced last month. Baxter will pay $240 million up front, plus up to $90 million in milestone payments. The total is worth up to 5.5 times ApaTech's sales of $60 million last year. Actifuse “will allow us to immediately enter the emerging bone fusion category, and ApaTech's product pipeline is highly complementary to our existing commercial and technical capabilities in biosurgery,” said Ron Lloyd, vice president and general manager of Baxter's BioTherapeutics and Regenerative Medicine. Actifuse is a silicate-substituted, calcium-phosphate synthetic bone graft material that combines a biostimulative scaffold with chemical properties that accelerate bone formation, according to ApaTech. Actifuse formulations include microgranules for small graft areas and E-Z Prep, which forms a cohesive graft in 20 minutes when mixed with blood or bone marrow aspirate. According to Andrew Lewis, a spokesperson for Baxter, the overall U.S. bone growth substitutes market is worth $1.5 billion, and the synthetic bone growth substitutes segment reached $145 million in 2009. The deal also will allow Baxter to gain access to ApaTech's global sales force, half of which is based in the United States.

Envoy, Merck Team for Research

Envoy Therapeutics Inc. has entered into a multiyear research collaboration agreement with an affiliate of Merck and Co. to explore novel diabetes and obesity drug targets. Envoy will use its bacTRAP technology to identify proteins expressed specifically in certain cell types, and Merck, which will provide an upfront fee and research funding, will develop compounds that modulate protein targets with therapeutic potential for the treatment of metabolic disorders. “Obesity and diabetes have become epidemics with horrific mortality rates and devastating social stigmas,” said Brad Margus, cofounder and CEO of Envoy. “We're thrilled that our technology will be applied toward discovering drug candidates for the growing millions of patients who suffer from these conditions.” Envoy will be eligible to receive payments at certain milestones associated with drug candidate development and royalties on any products resulting from the collaboration. “Partnering with companies developing innovative drug discovery technologies … is an essential part of our diabetes and obesity portfolio discovery strategy,” said Nancy A. Thornberry, senior vice president and franchise head for diabetes and obesity at Merck Research Laboratories.

Atherotech Taps Heart Experts

Atherotech Inc., maker of the VAP cholesterol test, which identifies markers for the metabolic syndrome, has added eight cardiovascular experts to its medical advisory board to guide the development of the company's disease management program. The new team comprises Dr. Eliot A. Brintman, director of the metabolism section of cardiovascular genetics and the LDL apheresis center at the University of Utah, Salt Lake City; Dr. Michael H. Davidson, director of preventive cardiology at the University of Chicago; Prakash C. Deedwania, chief of cardiology for the VA Central California HealthCare System, Fresno; Dr. Gary H. Gibbons, endowed director of Morehouse School of Medicine's Cardiovascular Research Institute, Atlanta; Dr. Peter H. Jones, medical director of the Methodist Weight Management Center in Houston; Dr. Richard B. Lanman, chief medical officer of Veracyte Inc., a molecular diagnostics company in South San Francisco, Calif.; Dr. Charles A. Reasner II, medical director of the Texas Diabetes Institute in San Antonio; and Dr. Peter B. Toth, chief of medicine at CGH Medical Center in Sterling, Ill. “Collectively, [they] have more than 150 years of clinical research, nearly 1,000 publications, and over 200 years of clinical patient care,” said Dr. Michael E. Cobble, Atherotech's chief medical officer. In addition to the VAP cholesterol test, Atherotech has more than a dozen cardiovascular and metabolic tests, including those for high-sensitivity C-reactive protein, lipoprotein-associated phospholipase A2, apoE genotype, N-terminal–pro brain natriuretic peptide, cystatin C, T3 and T4, and gamma-glutamyl transferase.

Unigene Restructures to Meet Debts

Unigene Laboratories, maker of Fortical, a nasal calcitonin treatment for postmenopausal osteoporosis, has restructured its debt financing agreement with Victory Park Capital Advisors, its primary shareholder and lender. The deal buys time for Unigene to pay off its debt and adds $13.6 million to its balance sheet. The family-owned biopharmaceutical company agreed to major management change and gave Victory two seats, including chairmanship, on its board of directors. Unigene's chairman, Jay Levy, relinquished his board seat and Ronald S. Levy, secretary, left that position but stayed on as executive vice president, according to the terms of the agreement filed with the Securities and Exchange Commission. The regulatory filing also states that Unigene “is obligated to use its reasonable best efforts to identify, interview, and negotiate with candidates for, and, subject to the board's approval, hire a new chief executive officer as successor to Warren Levy as soon as reasonably practicable.” Victory Park Capital's principal and founder, Richard N. Levy (no relation to the Levy family that runs Unigene), stepped in as chairman. Unigene reported a 2009 net loss of $13.4 million, more than double its 2008 net loss of $6.1 million. Unigene is currently focused on the development of salmon calcitonin in nasal and oral formulations for postmenopausal osteoporosis, Paget's disease, and hypercalcemia.

Reporters and editors from Elsevier's “The Pink Sheet” contributed to this column.

Baxter Acquires ApaTech

Baxter International Inc. will enter the bone fusion market through its acquisition of ApaTech, maker of the bone graft Actifuse, for up to $330 million, in a deal announced last month. Baxter will pay $240 million up front, plus up to $90 million in milestone payments. The total is worth up to 5.5 times ApaTech's sales of $60 million last year. Actifuse “will allow us to immediately enter the emerging bone fusion category, and ApaTech's product pipeline is highly complementary to our existing commercial and technical capabilities in biosurgery,” said Ron Lloyd, vice president and general manager of Baxter's BioTherapeutics and Regenerative Medicine. Actifuse is a silicate-substituted, calcium-phosphate synthetic bone graft material that combines a biostimulative scaffold with chemical properties that accelerate bone formation, according to ApaTech. Actifuse formulations include microgranules for small graft areas and E-Z Prep, which forms a cohesive graft in 20 minutes when mixed with blood or bone marrow aspirate. According to Andrew Lewis, a spokesperson for Baxter, the overall U.S. bone growth substitutes market is worth $1.5 billion, and the synthetic bone growth substitutes segment reached $145 million in 2009. The deal also will allow Baxter to gain access to ApaTech's global sales force, half of which is based in the United States.

Envoy, Merck Team for Research

Envoy Therapeutics Inc. has entered into a multiyear research collaboration agreement with an affiliate of Merck and Co. to explore novel diabetes and obesity drug targets. Envoy will use its bacTRAP technology to identify proteins expressed specifically in certain cell types, and Merck, which will provide an upfront fee and research funding, will develop compounds that modulate protein targets with therapeutic potential for the treatment of metabolic disorders. “Obesity and diabetes have become epidemics with horrific mortality rates and devastating social stigmas,” said Brad Margus, cofounder and CEO of Envoy. “We're thrilled that our technology will be applied toward discovering drug candidates for the growing millions of patients who suffer from these conditions.” Envoy will be eligible to receive payments at certain milestones associated with drug candidate development and royalties on any products resulting from the collaboration. “Partnering with companies developing innovative drug discovery technologies … is an essential part of our diabetes and obesity portfolio discovery strategy,” said Nancy A. Thornberry, senior vice president and franchise head for diabetes and obesity at Merck Research Laboratories.

Atherotech Taps Heart Experts

Atherotech Inc., maker of the VAP cholesterol test, which identifies markers for the metabolic syndrome, has added eight cardiovascular experts to its medical advisory board to guide the development of the company's disease management program. The new team comprises Dr. Eliot A. Brintman, director of the metabolism section of cardiovascular genetics and the LDL apheresis center at the University of Utah, Salt Lake City; Dr. Michael H. Davidson, director of preventive cardiology at the University of Chicago; Prakash C. Deedwania, chief of cardiology for the VA Central California HealthCare System, Fresno; Dr. Gary H. Gibbons, endowed director of Morehouse School of Medicine's Cardiovascular Research Institute, Atlanta; Dr. Peter H. Jones, medical director of the Methodist Weight Management Center in Houston; Dr. Richard B. Lanman, chief medical officer of Veracyte Inc., a molecular diagnostics company in South San Francisco, Calif.; Dr. Charles A. Reasner II, medical director of the Texas Diabetes Institute in San Antonio; and Dr. Peter B. Toth, chief of medicine at CGH Medical Center in Sterling, Ill. “Collectively, [they] have more than 150 years of clinical research, nearly 1,000 publications, and over 200 years of clinical patient care,” said Dr. Michael E. Cobble, Atherotech's chief medical officer. In addition to the VAP cholesterol test, Atherotech has more than a dozen cardiovascular and metabolic tests, including those for high-sensitivity C-reactive protein, lipoprotein-associated phospholipase A2, apoE genotype, N-terminal–pro brain natriuretic peptide, cystatin C, T3 and T4, and gamma-glutamyl transferase.

Unigene Restructures to Meet Debts

Unigene Laboratories, maker of Fortical, a nasal calcitonin treatment for postmenopausal osteoporosis, has restructured its debt financing agreement with Victory Park Capital Advisors, its primary shareholder and lender. The deal buys time for Unigene to pay off its debt and adds $13.6 million to its balance sheet. The family-owned biopharmaceutical company agreed to major management change and gave Victory two seats, including chairmanship, on its board of directors. Unigene's chairman, Jay Levy, relinquished his board seat and Ronald S. Levy, secretary, left that position but stayed on as executive vice president, according to the terms of the agreement filed with the Securities and Exchange Commission. The regulatory filing also states that Unigene “is obligated to use its reasonable best efforts to identify, interview, and negotiate with candidates for, and, subject to the board's approval, hire a new chief executive officer as successor to Warren Levy as soon as reasonably practicable.” Victory Park Capital's principal and founder, Richard N. Levy (no relation to the Levy family that runs Unigene), stepped in as chairman. Unigene reported a 2009 net loss of $13.4 million, more than double its 2008 net loss of $6.1 million. Unigene is currently focused on the development of salmon calcitonin in nasal and oral formulations for postmenopausal osteoporosis, Paget's disease, and hypercalcemia.

Reporters and editors from Elsevier's “The Pink Sheet” contributed to this column.

Botox Approved for Limb Spasticity

OnabotulinumtoxinA (Botox, Allergan) received FDA approval for the treatment of upper limb spasticity in adults, following a series of clinical trials showing that injections of the neurotoxin could significantly improve the tone and function of the flexor muscles of the elbow, wrist, and fingers.

Such spasticity can develop—sometimes after a long delay—following a stroke, spinal cord injury, or traumatic brain injury, or in advanced multiple sclerosis or cerebral palsy. The approval did not extend to the use of Botox for nonflexural muscles of the upper limbs, spasticity in the legs, or treatment of fixed contracture, the FDA noted.

The most common side effects experienced by study subjects were nausea, fatigue, bronchitis, muscle weakness, and pain in the arms. A black box warning says that the effects of Botox may extend beyond the area of injection, resulting in temporary paralysis that could affect swallowing and breathing.

Myopathy Occurs With Simvastatin

The risk of myopathy is increased when the highest dose of simvastatin is used, according to the Food and Drug Administration, which is conducting a safety review of the statin.

In a statement, the FDA advises health care professionals to be aware of the potential increased risk of muscle injury associated with the 80-mg dose of simvastatin, when compared with lower doses of simvastatin and “possibly other statin drugs.” Although myopathy is a known side effect associated with all statins, this warning “highlights the greater risk of developing muscle injury, including rhabdomyolysis,” when patients use higher doses of simvastatin.

Simvastatin is marketed as Zocor and is also available as a generic formulation. The drug also is combined with ezetimibe (Vytorin) and with niacin (Simcor).

Preliminary data from more than 6,000 patients taking simvastatin for almost 7 years showed that 52 (0.9%) of patients on the 80-mg dose developed myopathy, compared with 1 patient (0.02%) on the 20-mg dose. Eleven patients (0.02%) taking the 80-mg dose developed rhabdomyolysis, but none in the low-dose group developed the condition.

Plavix Not for Poor Metabolizers

The FDA updated the labeling for clopidogrel to emphasize that new data definitively show that the antiplatelet agent is less effective—and may not work at all—in patients defined as “poor metabolizers.”

The agency, which is notifying physicians that testing is available for the genotypes that are associated with poor metabolism, stopped short of recommending that all patients receive such testing before starting a course of clopidogrel (Plavix, Sanofi-Aventis). An estimated 2%–14% of the population probably have those alleles and are poor metabolizers, according to the FDA.

The FDA urges physicians to consider use of other antiplatelet agents in poor metabolizers, such as ticlopidine (Ticlid) or prasugrel (Effient), or potentially increasing the clopidogrel dose. Prasugrel did not seem to have the same metabolism issue.

Lung Drug Gets Okay From Panel

The FDA's Pulmonary-Allergy Drugs Advisory Committee voted 9-3 to recommend approval of pirfenidone for the reduction in the decline of lung function in idiopathic pulmonary fibrosis (IPF). Those who voted in favor of approval agreed that the data on the drug showed that treatment was beneficial in slowing the progression of the disease.

Panelists said, however, that more data are needed to help identify which subsets of patients with IPF may benefit the most from treatment. The panel also recommended that safety of the drug should be monitored long term, possibly in a patient registry.

There is no FDA-approved treatment for IPF, a progressive, irreversible diffuse parenchymal lung disease of unknown etiology that is typically diagnosed after age 50. Approximately 100,000 people in the United States have the disease, according to pirfenidone's manufacturer, InterMune.

Panel Votes Yes on DBS for Seizures

The FDA's Neurological Devices Advisory Panel voted 7–5 to recommend approval, with conditions, of an implantable device that delivers electrical stimulation to the brain as an adjunctive treatment for adults with refractory seizures.

The panel reviewed the data from one study of 109 patients on the Deep Brain Stimulation (DBS) System for Epilepsy, manufactured by Medtronic, which provides bilateral stimulation of the anterior thalamic nucleus. The proposed indication for the device is as adjunctive therapy for reducing the frequency of seizures in adults with epilepsy characterized by partial-onset seizures that are refractory to antiepileptic medications.

Panel members voting in favor of approval agreed that the study provided adequate efficacy and safety data on the device in this patient population. Those voting against approval were satisfied with the safety data, but said they did not consider the efficacy data robust enough to support approval.

The components of the DBS system include a neurostimulator that connects to two leads that are implanted in the anterior nucleus of the thalamus. The same system is already approved for treating essential tremor of Parkinson's disease.

Safety of Insulin Pumps Reviewed

Members of the FDA's General Hospital and Personal Use Devices Panel agreed that although there are technological issues with insulin infusion pumps, these are outweighed by user-related issues.

During 2006–2009, the FDA received 16,849 reports of adverse events (including 310 deaths) associated with insulin pumps; most were reported by the manufacturers. The reports were far from complete: In most cases the problem with the pump was not described, and the cause of death had not been thoroughly evaluated, according to the FDA. The most common device problems were listed as unknown (20%), replace (9%), display of an error message (almost 5%), failure to deliver (3%), and repair (3%).

Of the 310 deaths, the most commonly listed causes were diabetic coma, hyperglycemia, hypoglycemia, diabetic ketoacidosis, and unresponsiveness. There were 29 deaths associated with a motor vehicle.

Botox Approved for Limb Spasticity

OnabotulinumtoxinA (Botox, Allergan) received FDA approval for the treatment of upper limb spasticity in adults, following a series of clinical trials showing that injections of the neurotoxin could significantly improve the tone and function of the flexor muscles of the elbow, wrist, and fingers.

Such spasticity can develop—sometimes after a long delay—following a stroke, spinal cord injury, or traumatic brain injury, or in advanced multiple sclerosis or cerebral palsy. The approval did not extend to the use of Botox for nonflexural muscles of the upper limbs, spasticity in the legs, or treatment of fixed contracture, the FDA noted.

The most common side effects experienced by study subjects were nausea, fatigue, bronchitis, muscle weakness, and pain in the arms. A black box warning says that the effects of Botox may extend beyond the area of injection, resulting in temporary paralysis that could affect swallowing and breathing.

Myopathy Occurs With Simvastatin

The risk of myopathy is increased when the highest dose of simvastatin is used, according to the Food and Drug Administration, which is conducting a safety review of the statin.

In a statement, the FDA advises health care professionals to be aware of the potential increased risk of muscle injury associated with the 80-mg dose of simvastatin, when compared with lower doses of simvastatin and “possibly other statin drugs.” Although myopathy is a known side effect associated with all statins, this warning “highlights the greater risk of developing muscle injury, including rhabdomyolysis,” when patients use higher doses of simvastatin.

Simvastatin is marketed as Zocor and is also available as a generic formulation. The drug also is combined with ezetimibe (Vytorin) and with niacin (Simcor).

Preliminary data from more than 6,000 patients taking simvastatin for almost 7 years showed that 52 (0.9%) of patients on the 80-mg dose developed myopathy, compared with 1 patient (0.02%) on the 20-mg dose. Eleven patients (0.02%) taking the 80-mg dose developed rhabdomyolysis, but none in the low-dose group developed the condition.

Plavix Not for Poor Metabolizers

The FDA updated the labeling for clopidogrel to emphasize that new data definitively show that the antiplatelet agent is less effective—and may not work at all—in patients defined as “poor metabolizers.”

The agency, which is notifying physicians that testing is available for the genotypes that are associated with poor metabolism, stopped short of recommending that all patients receive such testing before starting a course of clopidogrel (Plavix, Sanofi-Aventis). An estimated 2%–14% of the population probably have those alleles and are poor metabolizers, according to the FDA.

The FDA urges physicians to consider use of other antiplatelet agents in poor metabolizers, such as ticlopidine (Ticlid) or prasugrel (Effient), or potentially increasing the clopidogrel dose. Prasugrel did not seem to have the same metabolism issue.

Lung Drug Gets Okay From Panel

The FDA's Pulmonary-Allergy Drugs Advisory Committee voted 9-3 to recommend approval of pirfenidone for the reduction in the decline of lung function in idiopathic pulmonary fibrosis (IPF). Those who voted in favor of approval agreed that the data on the drug showed that treatment was beneficial in slowing the progression of the disease.

Panelists said, however, that more data are needed to help identify which subsets of patients with IPF may benefit the most from treatment. The panel also recommended that safety of the drug should be monitored long term, possibly in a patient registry.

There is no FDA-approved treatment for IPF, a progressive, irreversible diffuse parenchymal lung disease of unknown etiology that is typically diagnosed after age 50. Approximately 100,000 people in the United States have the disease, according to pirfenidone's manufacturer, InterMune.

Panel Votes Yes on DBS for Seizures

The FDA's Neurological Devices Advisory Panel voted 7–5 to recommend approval, with conditions, of an implantable device that delivers electrical stimulation to the brain as an adjunctive treatment for adults with refractory seizures.

The panel reviewed the data from one study of 109 patients on the Deep Brain Stimulation (DBS) System for Epilepsy, manufactured by Medtronic, which provides bilateral stimulation of the anterior thalamic nucleus. The proposed indication for the device is as adjunctive therapy for reducing the frequency of seizures in adults with epilepsy characterized by partial-onset seizures that are refractory to antiepileptic medications.

Panel members voting in favor of approval agreed that the study provided adequate efficacy and safety data on the device in this patient population. Those voting against approval were satisfied with the safety data, but said they did not consider the efficacy data robust enough to support approval.

The components of the DBS system include a neurostimulator that connects to two leads that are implanted in the anterior nucleus of the thalamus. The same system is already approved for treating essential tremor of Parkinson's disease.

Safety of Insulin Pumps Reviewed

Members of the FDA's General Hospital and Personal Use Devices Panel agreed that although there are technological issues with insulin infusion pumps, these are outweighed by user-related issues.

During 2006–2009, the FDA received 16,849 reports of adverse events (including 310 deaths) associated with insulin pumps; most were reported by the manufacturers. The reports were far from complete: In most cases the problem with the pump was not described, and the cause of death had not been thoroughly evaluated, according to the FDA. The most common device problems were listed as unknown (20%), replace (9%), display of an error message (almost 5%), failure to deliver (3%), and repair (3%).

Of the 310 deaths, the most commonly listed causes were diabetic coma, hyperglycemia, hypoglycemia, diabetic ketoacidosis, and unresponsiveness. There were 29 deaths associated with a motor vehicle.

Botox Approved for Limb Spasticity

OnabotulinumtoxinA (Botox, Allergan) received FDA approval for the treatment of upper limb spasticity in adults, following a series of clinical trials showing that injections of the neurotoxin could significantly improve the tone and function of the flexor muscles of the elbow, wrist, and fingers.

Such spasticity can develop—sometimes after a long delay—following a stroke, spinal cord injury, or traumatic brain injury, or in advanced multiple sclerosis or cerebral palsy. The approval did not extend to the use of Botox for nonflexural muscles of the upper limbs, spasticity in the legs, or treatment of fixed contracture, the FDA noted.

The most common side effects experienced by study subjects were nausea, fatigue, bronchitis, muscle weakness, and pain in the arms. A black box warning says that the effects of Botox may extend beyond the area of injection, resulting in temporary paralysis that could affect swallowing and breathing.

Myopathy Occurs With Simvastatin

The risk of myopathy is increased when the highest dose of simvastatin is used, according to the Food and Drug Administration, which is conducting a safety review of the statin.

In a statement, the FDA advises health care professionals to be aware of the potential increased risk of muscle injury associated with the 80-mg dose of simvastatin, when compared with lower doses of simvastatin and “possibly other statin drugs.” Although myopathy is a known side effect associated with all statins, this warning “highlights the greater risk of developing muscle injury, including rhabdomyolysis,” when patients use higher doses of simvastatin.

Simvastatin is marketed as Zocor and is also available as a generic formulation. The drug also is combined with ezetimibe (Vytorin) and with niacin (Simcor).

Preliminary data from more than 6,000 patients taking simvastatin for almost 7 years showed that 52 (0.9%) of patients on the 80-mg dose developed myopathy, compared with 1 patient (0.02%) on the 20-mg dose. Eleven patients (0.02%) taking the 80-mg dose developed rhabdomyolysis, but none in the low-dose group developed the condition.

Plavix Not for Poor Metabolizers

The FDA updated the labeling for clopidogrel to emphasize that new data definitively show that the antiplatelet agent is less effective—and may not work at all—in patients defined as “poor metabolizers.”

The agency, which is notifying physicians that testing is available for the genotypes that are associated with poor metabolism, stopped short of recommending that all patients receive such testing before starting a course of clopidogrel (Plavix, Sanofi-Aventis). An estimated 2%–14% of the population probably have those alleles and are poor metabolizers, according to the FDA.

The FDA urges physicians to consider use of other antiplatelet agents in poor metabolizers, such as ticlopidine (Ticlid) or prasugrel (Effient), or potentially increasing the clopidogrel dose. Prasugrel did not seem to have the same metabolism issue.

Lung Drug Gets Okay From Panel

The FDA's Pulmonary-Allergy Drugs Advisory Committee voted 9-3 to recommend approval of pirfenidone for the reduction in the decline of lung function in idiopathic pulmonary fibrosis (IPF). Those who voted in favor of approval agreed that the data on the drug showed that treatment was beneficial in slowing the progression of the disease.

Panelists said, however, that more data are needed to help identify which subsets of patients with IPF may benefit the most from treatment. The panel also recommended that safety of the drug should be monitored long term, possibly in a patient registry.

There is no FDA-approved treatment for IPF, a progressive, irreversible diffuse parenchymal lung disease of unknown etiology that is typically diagnosed after age 50. Approximately 100,000 people in the United States have the disease, according to pirfenidone's manufacturer, InterMune.

Panel Votes Yes on DBS for Seizures

The FDA's Neurological Devices Advisory Panel voted 7–5 to recommend approval, with conditions, of an implantable device that delivers electrical stimulation to the brain as an adjunctive treatment for adults with refractory seizures.

The panel reviewed the data from one study of 109 patients on the Deep Brain Stimulation (DBS) System for Epilepsy, manufactured by Medtronic, which provides bilateral stimulation of the anterior thalamic nucleus. The proposed indication for the device is as adjunctive therapy for reducing the frequency of seizures in adults with epilepsy characterized by partial-onset seizures that are refractory to antiepileptic medications.

Panel members voting in favor of approval agreed that the study provided adequate efficacy and safety data on the device in this patient population. Those voting against approval were satisfied with the safety data, but said they did not consider the efficacy data robust enough to support approval.

The components of the DBS system include a neurostimulator that connects to two leads that are implanted in the anterior nucleus of the thalamus. The same system is already approved for treating essential tremor of Parkinson's disease.

Safety of Insulin Pumps Reviewed

Members of the FDA's General Hospital and Personal Use Devices Panel agreed that although there are technological issues with insulin infusion pumps, these are outweighed by user-related issues.

During 2006–2009, the FDA received 16,849 reports of adverse events (including 310 deaths) associated with insulin pumps; most were reported by the manufacturers. The reports were far from complete: In most cases the problem with the pump was not described, and the cause of death had not been thoroughly evaluated, according to the FDA. The most common device problems were listed as unknown (20%), replace (9%), display of an error message (almost 5%), failure to deliver (3%), and repair (3%).

Of the 310 deaths, the most commonly listed causes were diabetic coma, hyperglycemia, hypoglycemia, diabetic ketoacidosis, and unresponsiveness. There were 29 deaths associated with a motor vehicle.

PositiveID Buys Easy Check

PositiveID Corp. announced last month that it had bought the assets and intellectual property rights of Easy Check Medical Diagnostics, LLC. Terms of the deal were not disclosed. Easy Check is developing two primary products: a breath glucose detection system and a wireless communication device for diabetes management. The breath glucose test measures acetone levels in a patient's exhaled breath. PositiveID said in a statement that it believes that the test “may prove the close correlation between acetone concentrations found in a patient's exhaled breath and glucose found in his or her blood. This could eliminate a patient's need to prick his or her finger multiple times per day to get a blood sugar reading.” The iGlucose system, Easy Check's other product under development, uses wireless messages to send a diabetes patient's glucose readings on an online database; the system is “intended to provide next generation, real-time data to improve diabetes management and help ensure patient compliance, data accuracy, and insurance reimbursement,” according to PositiveID. Easy Check founder Benjamin Atkin noted that “By joining forces with PositiveID and leveraging their experience in bringing products to market, we will be able to accelerate the path to commercialization for our Easy Check breath glucose test and our iGlucose communication device.” For its part, PositiveID, along with partner company Receptors LLC, is developing a glucose-sensing microchip to detect glucose levels in the human body. Phase II development of that product is expected to be completed by the middle of this year.

Novartis Splits Top Positions

Novartis, maker of the osteoporosis drug Reclast, has named Joe Jimenez, who had been running Novartis Pharmaceuticals, as the company's CEO, effective Feb. 1. Long-time chairman and CEO Dr. David Vasella will remain as chairman. In announcing Mr. Jimenez' appointment on the company's fourth-quarter earnings call, Dr. Vasella said the company was simplifying its organizational structure. As part of the move, David Epstein, currently head of the oncology business, which is the company's fastest-growing unit in pharmaceuticals, was named to replace Mr. Jimenez as global division head of pharmaceuticals. Jon Symonds will become chief financial officer, replacing Raymund Breu, who is retiring. The announcement brings some closure to a process that began officially more than a year ago, as Novartis worked on its succession planning. The last phase was set in motion in October 2008, when Joerg Reinhardt, then head of vaccines and diagnostics, was named to the newly created post of chief operating officer and several other top executives were moved around.

Nipro Buys Home Diagnostics

Diversified device and drug maker Nipro will acquire diabetes test maker Home Diagnostics Inc. for $215 million under a Feb. 3 deal announced last month. If the deal proceeds as planned, Nipro would pay $11.50 per share for Fort Lauderdale, Fla.–based Home Diagnostics—a 90% premium over its Feb. 2 closing price of $6.05. Merging with Nipro would benefit Home Diagnostics' customers and suppliers by expanding product offerings and by “aligning our business with a global healthcare company,” Home Diagnostics CEO Joseph Capper explained. Home Diagnostics makes a broad range of blood glucose monitors, including TRUE2go, TRUEresult, TRUEtrack, TRUEbalance, Sidekick, and TRUEread systems, as well as related test strips and accessories. Home Diagnostics reported quarterly sales of $34.5 million last November, the most recent period for which figures are available. The third-quarter total represents a 3% decline from the prior year. Nipro, with annual sales of about $1.9 billion, makes devices and drugs, medical device manufacturing equipment and nonmedical glass products. Device offerings include diabetes-related products such as the Amigo insulin pump, as well as devices for dialysis, infusion and intervention anesthesiology.

Merck Fertility Drug Gets European OK

MSD, the non–North American division of Merck & Co. Inc., has received European Commission (EC) approval for Elonva (corifollitropin alfa injection), an ovarian stimulation drug. Elonva is used in combination with a GnRH antagonist for the development of multiple follicles in women undergoing infertility treatment. EC approval allows the company to begin marketing the drug in all European Union member states. “The European approval of Elonva is a positive step towards reducing the burden of injections for women experiencing difficulty conceiving,” Mirjam Mol-Arts, senior vice president, Merck Research Laboratories, said in a statement.

Medco Snaps Up DNA Direct

Medco has purchased DNA Direct, a firm that counsels patients on DNA testing. The deal was announced last month; financial terms were not disclosed. The purchase will enable Medco, a pharmacy benefits manager, to grow its personalized medicine business by adding decision support services for payors, providers and patients. During the past 3 years, Medco has focused its personalized medicine business around pharmacogenomics, or drug-related genetic testing. But the purchase of privately held DNA Direct was driven by a need to dive into the market more quickly, according to Dr. Rob Epstein, Medco's chief medical officer. The 5-year-old DNA Direct does not develop or run tests, but instead guides providers and patients through the genetic testing process. The genetic counselors DNA Direct employs could provide valuable input into the design of Medco's clinical studies “because of their expertise around asking the right questions in the right way and engaging people in a certain way,” said Dr. Epstein. “It's something we are looking forward to help bolster our [research and development] initiative.”

Reporters and editors from Elsevier's “The Pink Sheet” contributed to this column.

PositiveID Buys Easy Check

PositiveID Corp. announced last month that it had bought the assets and intellectual property rights of Easy Check Medical Diagnostics, LLC. Terms of the deal were not disclosed. Easy Check is developing two primary products: a breath glucose detection system and a wireless communication device for diabetes management. The breath glucose test measures acetone levels in a patient's exhaled breath. PositiveID said in a statement that it believes that the test “may prove the close correlation between acetone concentrations found in a patient's exhaled breath and glucose found in his or her blood. This could eliminate a patient's need to prick his or her finger multiple times per day to get a blood sugar reading.” The iGlucose system, Easy Check's other product under development, uses wireless messages to send a diabetes patient's glucose readings on an online database; the system is “intended to provide next generation, real-time data to improve diabetes management and help ensure patient compliance, data accuracy, and insurance reimbursement,” according to PositiveID. Easy Check founder Benjamin Atkin noted that “By joining forces with PositiveID and leveraging their experience in bringing products to market, we will be able to accelerate the path to commercialization for our Easy Check breath glucose test and our iGlucose communication device.” For its part, PositiveID, along with partner company Receptors LLC, is developing a glucose-sensing microchip to detect glucose levels in the human body. Phase II development of that product is expected to be completed by the middle of this year.

Novartis Splits Top Positions

Novartis, maker of the osteoporosis drug Reclast, has named Joe Jimenez, who had been running Novartis Pharmaceuticals, as the company's CEO, effective Feb. 1. Long-time chairman and CEO Dr. David Vasella will remain as chairman. In announcing Mr. Jimenez' appointment on the company's fourth-quarter earnings call, Dr. Vasella said the company was simplifying its organizational structure. As part of the move, David Epstein, currently head of the oncology business, which is the company's fastest-growing unit in pharmaceuticals, was named to replace Mr. Jimenez as global division head of pharmaceuticals. Jon Symonds will become chief financial officer, replacing Raymund Breu, who is retiring. The announcement brings some closure to a process that began officially more than a year ago, as Novartis worked on its succession planning. The last phase was set in motion in October 2008, when Joerg Reinhardt, then head of vaccines and diagnostics, was named to the newly created post of chief operating officer and several other top executives were moved around.

Nipro Buys Home Diagnostics

Diversified device and drug maker Nipro will acquire diabetes test maker Home Diagnostics Inc. for $215 million under a Feb. 3 deal announced last month. If the deal proceeds as planned, Nipro would pay $11.50 per share for Fort Lauderdale, Fla.–based Home Diagnostics—a 90% premium over its Feb. 2 closing price of $6.05. Merging with Nipro would benefit Home Diagnostics' customers and suppliers by expanding product offerings and by “aligning our business with a global healthcare company,” Home Diagnostics CEO Joseph Capper explained. Home Diagnostics makes a broad range of blood glucose monitors, including TRUE2go, TRUEresult, TRUEtrack, TRUEbalance, Sidekick, and TRUEread systems, as well as related test strips and accessories. Home Diagnostics reported quarterly sales of $34.5 million last November, the most recent period for which figures are available. The third-quarter total represents a 3% decline from the prior year. Nipro, with annual sales of about $1.9 billion, makes devices and drugs, medical device manufacturing equipment and nonmedical glass products. Device offerings include diabetes-related products such as the Amigo insulin pump, as well as devices for dialysis, infusion and intervention anesthesiology.

Merck Fertility Drug Gets European OK

MSD, the non–North American division of Merck & Co. Inc., has received European Commission (EC) approval for Elonva (corifollitropin alfa injection), an ovarian stimulation drug. Elonva is used in combination with a GnRH antagonist for the development of multiple follicles in women undergoing infertility treatment. EC approval allows the company to begin marketing the drug in all European Union member states. “The European approval of Elonva is a positive step towards reducing the burden of injections for women experiencing difficulty conceiving,” Mirjam Mol-Arts, senior vice president, Merck Research Laboratories, said in a statement.

Medco Snaps Up DNA Direct

Medco has purchased DNA Direct, a firm that counsels patients on DNA testing. The deal was announced last month; financial terms were not disclosed. The purchase will enable Medco, a pharmacy benefits manager, to grow its personalized medicine business by adding decision support services for payors, providers and patients. During the past 3 years, Medco has focused its personalized medicine business around pharmacogenomics, or drug-related genetic testing. But the purchase of privately held DNA Direct was driven by a need to dive into the market more quickly, according to Dr. Rob Epstein, Medco's chief medical officer. The 5-year-old DNA Direct does not develop or run tests, but instead guides providers and patients through the genetic testing process. The genetic counselors DNA Direct employs could provide valuable input into the design of Medco's clinical studies “because of their expertise around asking the right questions in the right way and engaging people in a certain way,” said Dr. Epstein. “It's something we are looking forward to help bolster our [research and development] initiative.”

Reporters and editors from Elsevier's “The Pink Sheet” contributed to this column.

PositiveID Buys Easy Check

PositiveID Corp. announced last month that it had bought the assets and intellectual property rights of Easy Check Medical Diagnostics, LLC. Terms of the deal were not disclosed. Easy Check is developing two primary products: a breath glucose detection system and a wireless communication device for diabetes management. The breath glucose test measures acetone levels in a patient's exhaled breath. PositiveID said in a statement that it believes that the test “may prove the close correlation between acetone concentrations found in a patient's exhaled breath and glucose found in his or her blood. This could eliminate a patient's need to prick his or her finger multiple times per day to get a blood sugar reading.” The iGlucose system, Easy Check's other product under development, uses wireless messages to send a diabetes patient's glucose readings on an online database; the system is “intended to provide next generation, real-time data to improve diabetes management and help ensure patient compliance, data accuracy, and insurance reimbursement,” according to PositiveID. Easy Check founder Benjamin Atkin noted that “By joining forces with PositiveID and leveraging their experience in bringing products to market, we will be able to accelerate the path to commercialization for our Easy Check breath glucose test and our iGlucose communication device.” For its part, PositiveID, along with partner company Receptors LLC, is developing a glucose-sensing microchip to detect glucose levels in the human body. Phase II development of that product is expected to be completed by the middle of this year.

Novartis Splits Top Positions

Novartis, maker of the osteoporosis drug Reclast, has named Joe Jimenez, who had been running Novartis Pharmaceuticals, as the company's CEO, effective Feb. 1. Long-time chairman and CEO Dr. David Vasella will remain as chairman. In announcing Mr. Jimenez' appointment on the company's fourth-quarter earnings call, Dr. Vasella said the company was simplifying its organizational structure. As part of the move, David Epstein, currently head of the oncology business, which is the company's fastest-growing unit in pharmaceuticals, was named to replace Mr. Jimenez as global division head of pharmaceuticals. Jon Symonds will become chief financial officer, replacing Raymund Breu, who is retiring. The announcement brings some closure to a process that began officially more than a year ago, as Novartis worked on its succession planning. The last phase was set in motion in October 2008, when Joerg Reinhardt, then head of vaccines and diagnostics, was named to the newly created post of chief operating officer and several other top executives were moved around.

Nipro Buys Home Diagnostics

Diversified device and drug maker Nipro will acquire diabetes test maker Home Diagnostics Inc. for $215 million under a Feb. 3 deal announced last month. If the deal proceeds as planned, Nipro would pay $11.50 per share for Fort Lauderdale, Fla.–based Home Diagnostics—a 90% premium over its Feb. 2 closing price of $6.05. Merging with Nipro would benefit Home Diagnostics' customers and suppliers by expanding product offerings and by “aligning our business with a global healthcare company,” Home Diagnostics CEO Joseph Capper explained. Home Diagnostics makes a broad range of blood glucose monitors, including TRUE2go, TRUEresult, TRUEtrack, TRUEbalance, Sidekick, and TRUEread systems, as well as related test strips and accessories. Home Diagnostics reported quarterly sales of $34.5 million last November, the most recent period for which figures are available. The third-quarter total represents a 3% decline from the prior year. Nipro, with annual sales of about $1.9 billion, makes devices and drugs, medical device manufacturing equipment and nonmedical glass products. Device offerings include diabetes-related products such as the Amigo insulin pump, as well as devices for dialysis, infusion and intervention anesthesiology.

Merck Fertility Drug Gets European OK

MSD, the non–North American division of Merck & Co. Inc., has received European Commission (EC) approval for Elonva (corifollitropin alfa injection), an ovarian stimulation drug. Elonva is used in combination with a GnRH antagonist for the development of multiple follicles in women undergoing infertility treatment. EC approval allows the company to begin marketing the drug in all European Union member states. “The European approval of Elonva is a positive step towards reducing the burden of injections for women experiencing difficulty conceiving,” Mirjam Mol-Arts, senior vice president, Merck Research Laboratories, said in a statement.

Medco Snaps Up DNA Direct

Medco has purchased DNA Direct, a firm that counsels patients on DNA testing. The deal was announced last month; financial terms were not disclosed. The purchase will enable Medco, a pharmacy benefits manager, to grow its personalized medicine business by adding decision support services for payors, providers and patients. During the past 3 years, Medco has focused its personalized medicine business around pharmacogenomics, or drug-related genetic testing. But the purchase of privately held DNA Direct was driven by a need to dive into the market more quickly, according to Dr. Rob Epstein, Medco's chief medical officer. The 5-year-old DNA Direct does not develop or run tests, but instead guides providers and patients through the genetic testing process. The genetic counselors DNA Direct employs could provide valuable input into the design of Medco's clinical studies “because of their expertise around asking the right questions in the right way and engaging people in a certain way,” said Dr. Epstein. “It's something we are looking forward to help bolster our [research and development] initiative.”

Reporters and editors from Elsevier's “The Pink Sheet” contributed to this column.

Liraglutide Licensed for Diabetes

The Food and Drug Administration has approved liraglutide as a once-daily injection for the treatment of type 2 diabetes.

Liraglutide, a human glucagonlike peptide 1 (GLP-1) receptor agonist that promotes glucose-dependent insulin secretion, will be marketed by Novo Nordisk under the name Victoza. It was licensed for use in combination with diet, exercise, and certain other glucose-lowering medications, but not as initial therapy. The first drug in this class, exenatide (Byetta, Amylin/Eli Lilly), was approved in 2005.

It should be used with caution in people with a history of pancreatitis, the FDA said. The most common side effects observed with liraglutide were headache, nausea, and diarrhea.

Novo Nordisk is required to conduct postmarketing cardiovascular and cancer safety studies. Also included in the approval is a Risk Evaluation and Mitigation Strategy (REMS) consisting of a medication guide and a communication plan.

Oral Morphine Solution Approved

A concentrated oral solution of morphine sulfate has been approved, rescuing a formulation that had been slated to be taken off the market last year until physician groups spoke up about its clinical utility and lack of equivalent products.

The approval of Roxane Laboratories' product cements the FDA's decision in April 2009 to reinstate the high-concentration oral solutions of morphine sulfate to the market, but not other unapproved narcotic products for which the agency had deemed that acceptable alternatives were available.

The solution is indicated for the relief of moderate to severe, acute, and chronic pain in opioid-tolerant patients, defined as those who are taking the equivalent of 60 mg/day of morphine. It will be available in doses of 100 mg/5 mL and 20 mg/1 mL.

The FDA's decision is part of the ongoing Unapproved Drugs Initiative that the agency began in 2006. Numerous other previously unapproved drugs, including some opioid formulations, have been approved through the initiative.

Combo Approved for Breast Cancer

The FDA approved lapatinib in combination with letrozole for the treatment of postmenopausal women with advanced breast cancer that is hormone receptor and HER2 positive and for whom hormonal therapy is indicated.

A kinase inhibitor, lapatinib (Tykerb) targets the HER2 protein that is overexpressed in HER2-positive breast cancer. Letrozole (Femara), an aromatase inhibitor, is used in patients with hormone-dependent breast cancer.

In a study sponsored by lapatinib manufacturer GlaxoSmithKline, progression-free survival was more than twofold higher among the women who were treated with the all-oral combination of these two agents, compared with those who received letrozole (Femara) alone, according to the statement issued by the FDA.

“It is too early to determine whether an improvement in overall survival will be observed in the clinical trial,” the statement said.

In the trial, median progression-free survival was 35.4 weeks among the 111 women who received lapatinib (1,500 mg/day) plus letrozole (2.5 mg/day), compared with a median of 13 weeks among the 108 women who received letrozole alone, according to the revised label for lapatinib.

Drug to Aid Walking in MS Okayed

A sustained-release formulation of the potassium channel blocker dalfampridine has been approved as a treatment to improve walking in people with multiple sclerosis.

In a statement, the FDA announced that dalfampridine extended-release tablets had been approved for this indication, based on studies that found patients treated with the drug had faster walking speeds than did those treated with placebo. This is the first drug approved for this indication, according to the FDA.

Dalfampridine will be marketed as Ampyra by Acorda Therapeutics.

The recommended dose of dalfampridine is 10 mg twice a day. However, higher doses have been associated with seizures, and the drug should not be taken by patients with moderate to severe kidney disease, whose blood levels with dalfampridine approach the levels that have been associated with seizures, according to the FDA statement.

The drug has a long history of use in the United States despite never having been approved, according to background documents filed by the FDA. For more than 20 years, dalfampridine has been compounded in pharmacies and used off-label to improve walking in people with various neurologic conditions.

McNeil Recalls More OTC Drugs

McNeil Consumer Healthcare is expanding its recall of several over-the-counter medications following an investigation into complaints that some products had a moldy smell and caused temporary GI symptoms.

In a press briefing to announce the expanded recall, FDA officials called McNeil to task for acting too slowly.

The voluntary recall affects certain lots of Benadryl, Tylenol, Motrin IB, Rolaids, Simply Sleep, and St. Joseph Aspirin. A full list of the affected products and their lot numbers can be found at

www.mcneilproductrecall.com

The company is advising consumers who purchased products from among the recalled lots to stop using the product and contact McNeil for instructions on a refund or replacement.

This expanded recall comes after McNeil Consumer Healthcare recalled all lots of Tylenol Arthritis Pain 100 count in December 2009.

The recalls are based on consumer complaints going back to 2008 that some McNeil OTC products had an unusual moldy, musty, or mildewlike odor. The company also received complaints from consumers who temporarily became ill after taking the products. The most common symptoms reported were nausea, stomach pain, vomiting, and diarrhea.

After an investigation, the company concluded that the smell was caused by trace amounts of the chemical 2,4,6-tribromoanisole (TBA), which is used in treating the wood pallets used to transport and store product packaging materials. While the health effects of the chemical have not been well studied, officials at the FDA said no serious effects have been documented in the medical literature and so far all of the adverse events reported have been minor.

Fake Alli Has Dangerous Dose

An FDA analysis of counterfeit Alli, the OTC formulation of the lipase inhibitor orlistat, has found that the fake product also contains sibutramine and, when taken at the recommended daily dose, may deliver twice the recommended dose of that drug.

The agency reported that Alli manufacturer GlaxoSmithKline had determined there were counterfeit versions of Alli 60-mg capsules being sold over the Internet. The fake version contained sibutramine, a controlled substance marketed as Meridia by Abbott Laboratories.

Upon further analysis, the FDA determined that people taking the counterfeit pills may be getting up to three times the usual daily dose of sibutramine, or twice the recommended maximum dose. According to the agency, in healthy people, sibutramine can cause anxiety, nausea, heart palpitations, tachycardia, insomnia, and small increases in blood pressure. For those who have a history of cardiovascular disease, the excess dose can lead to elevated blood pressure, stroke, or MI.

CVD Contraindication for Sibutramine

The weight-loss drug sibutramine is now contraindicated in people with a history of cardiovascular disease, the FDA announced.

The recommendation was based on a review of data indicating an increased risk of MI and stroke is associated with use of the drug in this population.

The new contraindication states that sibutramine “is not to be used in patients with a history of cardiovascular disease,” including history of coronary artery disease, history of stroke or transient ischemic attack, history of heart arrhythmias, history of heart failure, history of peripheral artery disease, and uncontrolled hypertension.

The FDA announcement on the new contraindication came the day after the agency announced that counterfeit formulations of orlistat (Alli) were found to contain sibutramine.

COPD Inhaler Deemed Safe

Treatment with the Spiriva HandiHaler, which contains a dry powder formulation of the anticholinergic tiotropium, does not appear to be associated with an increased risk of stroke, MI, or cardiovascular death in patients with chronic obstructive pulmonary disease, the FDA announced.

The FDA has now completed its safety review of this product “and believes the available data do not support an association between the use of Spiriva HandiHaler and an increased risk for these serious adverse events,” according to a statement issued by the agency.

The Spiriva HandiHaler (Boehringer Ingelheim/Pfizer) was approved in 2004 for the long-term maintenance treatment of bronchospasm associated with COPD, including chronic bronchitis and emphysema. It is administered once daily.

In October 2008, the agency issued a statement about two published studies that suggested an increased risk of stroke, MI, and death in patients treated with tiotropium. But the latest FDA statement said that a 4-year study comparing treatment with the Spiriva Handi-Haler to placebo in almost 6,000 patients with COPD found no increase in the risk of these outcomes in the treatment arm.

Liraglutide Licensed for Diabetes

The Food and Drug Administration has approved liraglutide as a once-daily injection for the treatment of type 2 diabetes.

Liraglutide, a human glucagonlike peptide 1 (GLP-1) receptor agonist that promotes glucose-dependent insulin secretion, will be marketed by Novo Nordisk under the name Victoza. It was licensed for use in combination with diet, exercise, and certain other glucose-lowering medications, but not as initial therapy. The first drug in this class, exenatide (Byetta, Amylin/Eli Lilly), was approved in 2005.

It should be used with caution in people with a history of pancreatitis, the FDA said. The most common side effects observed with liraglutide were headache, nausea, and diarrhea.

Novo Nordisk is required to conduct postmarketing cardiovascular and cancer safety studies. Also included in the approval is a Risk Evaluation and Mitigation Strategy (REMS) consisting of a medication guide and a communication plan.

Oral Morphine Solution Approved

A concentrated oral solution of morphine sulfate has been approved, rescuing a formulation that had been slated to be taken off the market last year until physician groups spoke up about its clinical utility and lack of equivalent products.

The approval of Roxane Laboratories' product cements the FDA's decision in April 2009 to reinstate the high-concentration oral solutions of morphine sulfate to the market, but not other unapproved narcotic products for which the agency had deemed that acceptable alternatives were available.

The solution is indicated for the relief of moderate to severe, acute, and chronic pain in opioid-tolerant patients, defined as those who are taking the equivalent of 60 mg/day of morphine. It will be available in doses of 100 mg/5 mL and 20 mg/1 mL.

The FDA's decision is part of the ongoing Unapproved Drugs Initiative that the agency began in 2006. Numerous other previously unapproved drugs, including some opioid formulations, have been approved through the initiative.

Combo Approved for Breast Cancer

The FDA approved lapatinib in combination with letrozole for the treatment of postmenopausal women with advanced breast cancer that is hormone receptor and HER2 positive and for whom hormonal therapy is indicated.

A kinase inhibitor, lapatinib (Tykerb) targets the HER2 protein that is overexpressed in HER2-positive breast cancer. Letrozole (Femara), an aromatase inhibitor, is used in patients with hormone-dependent breast cancer.

In a study sponsored by lapatinib manufacturer GlaxoSmithKline, progression-free survival was more than twofold higher among the women who were treated with the all-oral combination of these two agents, compared with those who received letrozole (Femara) alone, according to the statement issued by the FDA.

“It is too early to determine whether an improvement in overall survival will be observed in the clinical trial,” the statement said.

In the trial, median progression-free survival was 35.4 weeks among the 111 women who received lapatinib (1,500 mg/day) plus letrozole (2.5 mg/day), compared with a median of 13 weeks among the 108 women who received letrozole alone, according to the revised label for lapatinib.

Drug to Aid Walking in MS Okayed

A sustained-release formulation of the potassium channel blocker dalfampridine has been approved as a treatment to improve walking in people with multiple sclerosis.

In a statement, the FDA announced that dalfampridine extended-release tablets had been approved for this indication, based on studies that found patients treated with the drug had faster walking speeds than did those treated with placebo. This is the first drug approved for this indication, according to the FDA.

Dalfampridine will be marketed as Ampyra by Acorda Therapeutics.

The recommended dose of dalfampridine is 10 mg twice a day. However, higher doses have been associated with seizures, and the drug should not be taken by patients with moderate to severe kidney disease, whose blood levels with dalfampridine approach the levels that have been associated with seizures, according to the FDA statement.

The drug has a long history of use in the United States despite never having been approved, according to background documents filed by the FDA. For more than 20 years, dalfampridine has been compounded in pharmacies and used off-label to improve walking in people with various neurologic conditions.

McNeil Recalls More OTC Drugs

McNeil Consumer Healthcare is expanding its recall of several over-the-counter medications following an investigation into complaints that some products had a moldy smell and caused temporary GI symptoms.

In a press briefing to announce the expanded recall, FDA officials called McNeil to task for acting too slowly.

The voluntary recall affects certain lots of Benadryl, Tylenol, Motrin IB, Rolaids, Simply Sleep, and St. Joseph Aspirin. A full list of the affected products and their lot numbers can be found at

www.mcneilproductrecall.com

The company is advising consumers who purchased products from among the recalled lots to stop using the product and contact McNeil for instructions on a refund or replacement.

This expanded recall comes after McNeil Consumer Healthcare recalled all lots of Tylenol Arthritis Pain 100 count in December 2009.

The recalls are based on consumer complaints going back to 2008 that some McNeil OTC products had an unusual moldy, musty, or mildewlike odor. The company also received complaints from consumers who temporarily became ill after taking the products. The most common symptoms reported were nausea, stomach pain, vomiting, and diarrhea.

After an investigation, the company concluded that the smell was caused by trace amounts of the chemical 2,4,6-tribromoanisole (TBA), which is used in treating the wood pallets used to transport and store product packaging materials. While the health effects of the chemical have not been well studied, officials at the FDA said no serious effects have been documented in the medical literature and so far all of the adverse events reported have been minor.

Fake Alli Has Dangerous Dose

An FDA analysis of counterfeit Alli, the OTC formulation of the lipase inhibitor orlistat, has found that the fake product also contains sibutramine and, when taken at the recommended daily dose, may deliver twice the recommended dose of that drug.

The agency reported that Alli manufacturer GlaxoSmithKline had determined there were counterfeit versions of Alli 60-mg capsules being sold over the Internet. The fake version contained sibutramine, a controlled substance marketed as Meridia by Abbott Laboratories.

Upon further analysis, the FDA determined that people taking the counterfeit pills may be getting up to three times the usual daily dose of sibutramine, or twice the recommended maximum dose. According to the agency, in healthy people, sibutramine can cause anxiety, nausea, heart palpitations, tachycardia, insomnia, and small increases in blood pressure. For those who have a history of cardiovascular disease, the excess dose can lead to elevated blood pressure, stroke, or MI.

CVD Contraindication for Sibutramine

The weight-loss drug sibutramine is now contraindicated in people with a history of cardiovascular disease, the FDA announced.

The recommendation was based on a review of data indicating an increased risk of MI and stroke is associated with use of the drug in this population.

The new contraindication states that sibutramine “is not to be used in patients with a history of cardiovascular disease,” including history of coronary artery disease, history of stroke or transient ischemic attack, history of heart arrhythmias, history of heart failure, history of peripheral artery disease, and uncontrolled hypertension.

The FDA announcement on the new contraindication came the day after the agency announced that counterfeit formulations of orlistat (Alli) were found to contain sibutramine.

COPD Inhaler Deemed Safe

Treatment with the Spiriva HandiHaler, which contains a dry powder formulation of the anticholinergic tiotropium, does not appear to be associated with an increased risk of stroke, MI, or cardiovascular death in patients with chronic obstructive pulmonary disease, the FDA announced.

The FDA has now completed its safety review of this product “and believes the available data do not support an association between the use of Spiriva HandiHaler and an increased risk for these serious adverse events,” according to a statement issued by the agency.

The Spiriva HandiHaler (Boehringer Ingelheim/Pfizer) was approved in 2004 for the long-term maintenance treatment of bronchospasm associated with COPD, including chronic bronchitis and emphysema. It is administered once daily.

In October 2008, the agency issued a statement about two published studies that suggested an increased risk of stroke, MI, and death in patients treated with tiotropium. But the latest FDA statement said that a 4-year study comparing treatment with the Spiriva Handi-Haler to placebo in almost 6,000 patients with COPD found no increase in the risk of these outcomes in the treatment arm.

Liraglutide Licensed for Diabetes

The Food and Drug Administration has approved liraglutide as a once-daily injection for the treatment of type 2 diabetes.

Liraglutide, a human glucagonlike peptide 1 (GLP-1) receptor agonist that promotes glucose-dependent insulin secretion, will be marketed by Novo Nordisk under the name Victoza. It was licensed for use in combination with diet, exercise, and certain other glucose-lowering medications, but not as initial therapy. The first drug in this class, exenatide (Byetta, Amylin/Eli Lilly), was approved in 2005.

It should be used with caution in people with a history of pancreatitis, the FDA said. The most common side effects observed with liraglutide were headache, nausea, and diarrhea.

Novo Nordisk is required to conduct postmarketing cardiovascular and cancer safety studies. Also included in the approval is a Risk Evaluation and Mitigation Strategy (REMS) consisting of a medication guide and a communication plan.

Oral Morphine Solution Approved

A concentrated oral solution of morphine sulfate has been approved, rescuing a formulation that had been slated to be taken off the market last year until physician groups spoke up about its clinical utility and lack of equivalent products.

The approval of Roxane Laboratories' product cements the FDA's decision in April 2009 to reinstate the high-concentration oral solutions of morphine sulfate to the market, but not other unapproved narcotic products for which the agency had deemed that acceptable alternatives were available.

The solution is indicated for the relief of moderate to severe, acute, and chronic pain in opioid-tolerant patients, defined as those who are taking the equivalent of 60 mg/day of morphine. It will be available in doses of 100 mg/5 mL and 20 mg/1 mL.

The FDA's decision is part of the ongoing Unapproved Drugs Initiative that the agency began in 2006. Numerous other previously unapproved drugs, including some opioid formulations, have been approved through the initiative.

Combo Approved for Breast Cancer

The FDA approved lapatinib in combination with letrozole for the treatment of postmenopausal women with advanced breast cancer that is hormone receptor and HER2 positive and for whom hormonal therapy is indicated.

A kinase inhibitor, lapatinib (Tykerb) targets the HER2 protein that is overexpressed in HER2-positive breast cancer. Letrozole (Femara), an aromatase inhibitor, is used in patients with hormone-dependent breast cancer.

In a study sponsored by lapatinib manufacturer GlaxoSmithKline, progression-free survival was more than twofold higher among the women who were treated with the all-oral combination of these two agents, compared with those who received letrozole (Femara) alone, according to the statement issued by the FDA.

“It is too early to determine whether an improvement in overall survival will be observed in the clinical trial,” the statement said.

In the trial, median progression-free survival was 35.4 weeks among the 111 women who received lapatinib (1,500 mg/day) plus letrozole (2.5 mg/day), compared with a median of 13 weeks among the 108 women who received letrozole alone, according to the revised label for lapatinib.

Drug to Aid Walking in MS Okayed

A sustained-release formulation of the potassium channel blocker dalfampridine has been approved as a treatment to improve walking in people with multiple sclerosis.

In a statement, the FDA announced that dalfampridine extended-release tablets had been approved for this indication, based on studies that found patients treated with the drug had faster walking speeds than did those treated with placebo. This is the first drug approved for this indication, according to the FDA.

Dalfampridine will be marketed as Ampyra by Acorda Therapeutics.

The recommended dose of dalfampridine is 10 mg twice a day. However, higher doses have been associated with seizures, and the drug should not be taken by patients with moderate to severe kidney disease, whose blood levels with dalfampridine approach the levels that have been associated with seizures, according to the FDA statement.

The drug has a long history of use in the United States despite never having been approved, according to background documents filed by the FDA. For more than 20 years, dalfampridine has been compounded in pharmacies and used off-label to improve walking in people with various neurologic conditions.

McNeil Recalls More OTC Drugs

McNeil Consumer Healthcare is expanding its recall of several over-the-counter medications following an investigation into complaints that some products had a moldy smell and caused temporary GI symptoms.

In a press briefing to announce the expanded recall, FDA officials called McNeil to task for acting too slowly.

The voluntary recall affects certain lots of Benadryl, Tylenol, Motrin IB, Rolaids, Simply Sleep, and St. Joseph Aspirin. A full list of the affected products and their lot numbers can be found at

www.mcneilproductrecall.com

The company is advising consumers who purchased products from among the recalled lots to stop using the product and contact McNeil for instructions on a refund or replacement.

This expanded recall comes after McNeil Consumer Healthcare recalled all lots of Tylenol Arthritis Pain 100 count in December 2009.

The recalls are based on consumer complaints going back to 2008 that some McNeil OTC products had an unusual moldy, musty, or mildewlike odor. The company also received complaints from consumers who temporarily became ill after taking the products. The most common symptoms reported were nausea, stomach pain, vomiting, and diarrhea.

After an investigation, the company concluded that the smell was caused by trace amounts of the chemical 2,4,6-tribromoanisole (TBA), which is used in treating the wood pallets used to transport and store product packaging materials. While the health effects of the chemical have not been well studied, officials at the FDA said no serious effects have been documented in the medical literature and so far all of the adverse events reported have been minor.

Fake Alli Has Dangerous Dose

An FDA analysis of counterfeit Alli, the OTC formulation of the lipase inhibitor orlistat, has found that the fake product also contains sibutramine and, when taken at the recommended daily dose, may deliver twice the recommended dose of that drug.

The agency reported that Alli manufacturer GlaxoSmithKline had determined there were counterfeit versions of Alli 60-mg capsules being sold over the Internet. The fake version contained sibutramine, a controlled substance marketed as Meridia by Abbott Laboratories.

Upon further analysis, the FDA determined that people taking the counterfeit pills may be getting up to three times the usual daily dose of sibutramine, or twice the recommended maximum dose. According to the agency, in healthy people, sibutramine can cause anxiety, nausea, heart palpitations, tachycardia, insomnia, and small increases in blood pressure. For those who have a history of cardiovascular disease, the excess dose can lead to elevated blood pressure, stroke, or MI.

CVD Contraindication for Sibutramine

The weight-loss drug sibutramine is now contraindicated in people with a history of cardiovascular disease, the FDA announced.

The recommendation was based on a review of data indicating an increased risk of MI and stroke is associated with use of the drug in this population.

The new contraindication states that sibutramine “is not to be used in patients with a history of cardiovascular disease,” including history of coronary artery disease, history of stroke or transient ischemic attack, history of heart arrhythmias, history of heart failure, history of peripheral artery disease, and uncontrolled hypertension.

The FDA announcement on the new contraindication came the day after the agency announced that counterfeit formulations of orlistat (Alli) were found to contain sibutramine.

COPD Inhaler Deemed Safe

Treatment with the Spiriva HandiHaler, which contains a dry powder formulation of the anticholinergic tiotropium, does not appear to be associated with an increased risk of stroke, MI, or cardiovascular death in patients with chronic obstructive pulmonary disease, the FDA announced.

The FDA has now completed its safety review of this product “and believes the available data do not support an association between the use of Spiriva HandiHaler and an increased risk for these serious adverse events,” according to a statement issued by the agency.

The Spiriva HandiHaler (Boehringer Ingelheim/Pfizer) was approved in 2004 for the long-term maintenance treatment of bronchospasm associated with COPD, including chronic bronchitis and emphysema. It is administered once daily.

In October 2008, the agency issued a statement about two published studies that suggested an increased risk of stroke, MI, and death in patients treated with tiotropium. But the latest FDA statement said that a 4-year study comparing treatment with the Spiriva Handi-Haler to placebo in almost 6,000 patients with COPD found no increase in the risk of these outcomes in the treatment arm.

JDRF, Animas Ink Deal

The Juvenile Diabetes Research Foundation is collaborating with Animas, a division of Johnson & Johnson, to develop an automated system for insulin delivery—“the first step on the path to … the development of an artificial pancreas,” according to a statement from the JDRF. The first-generation system would be partially automated and would involve an insulin pump connected wirelessly with a continuous glucose monitor. The CGM would transmit its reading to the insulin pump, which would house a sophisticated computer program designed to prevent hypoglycemia and extreme hyperglycemia. The pump would slow or stop insulin delivery if it detected blood sugar was going too low and would increase insulin delivery if blood sugar was too high. DexCom is supplying the CGM technology for the system. If successful, the development of this system “would begin the process of automating how people with diabetes manage their blood sugar,” said Alan Lewis, Ph.D., president and CEO of the JDRF. “Even this early system could bring dramatic changes in the quality of life for the 3 million people in the U.S. with type 1 diabetes, beginning to free kids and adults from testing, calculating, and treating themselves throughout the day.” The JDRF is providing $8 million in funding over 3 years for the project, and aims to have the system ready for regulatory review in about 4 years.

Takeda, Pfizer Market Actos in China

Takeda has signed a copromotion deal with Pfizer to market its Actos type 2 diabetes drug in China. U.S. market exclusivity for Actos (pioglitazone), which generated global sales of over $4 billion in 2008, ends in 2011. China is expected to become the third-largest pharmaceutical market by 2011 and many big drug makers have committed to developing business there, among other promising emerging countries. Pfizer is now the largest drug maker in the country, with 2008 sales of $428 million, a figure analysts project will grow to $1 billion in 2009. For the last 5 years, Takeda has in China been marketing Actos with Tianjin Takeda Pharmaceuticals, a joint venture of Takeda Pharmaceutical Company Limited and Tianjin Lisheng Pharmaceutical Co., a Chinese company. According to the new agreement, which is exclusive, Pfizer will market Actos with the Tianjin joint venture in exchange for an undisclosed cut of sales.

Phenomix Taking Dutogliptin to Europe

A little over a year after partnering with Forest Laboratories to develop the DPP-4 inhibitor dutogliptin for type 2 diabetes in North America, Phenomix has sealed a deal with Chiesi Farmaceutici to commercialize the drug in Europe. The deal is worth up to $28 million in near-term cash and the total value, which includes milestone payments, could reach $163 million. Dutogliptin is now part of a phase III clinical development program that includes five studies of 3,000 patients. The first results are due for release in the second quarter of 2010, according to Forest, which has been Phenomix's partner in North America since October 2008. Milestones in the Chiesi agreement are tied to development and commercialization of dutogliptin in Europe and other territories including Brazil, Russia, and all other members of the Commonwealth of Independent States, Turkey, and North Africa. Chiesi, of Parma, Italy, will be responsible for product development, regulatory approval, and commercialization in the territories covered by the deal. Phenomix, based in San Diego, will also receive an undisclosed cut of sales.

EndoBarrier Gets CE Mark

The EndoBarrier, an investigational gastrointestinal liner designed to mimic the effects of Roux-en-Y gastric bypass, has received CE mark approval for marketing in Europe, the product's maker, GI Dynamics, said in a statement. The EndoBarrier gastrointestinal liner is placed in the GI tract endoscopically to create a barrier between food and the wall of the intestine. The company noted that clinical trials involving more than 270 patients have shown the significant weight loss and diabetes improvement achieved with the EndoBarrier system. “This European approval for 6 months of EndoBarrier therapy to treat type 2 diabetes and obesity is another key milestone for GI Dynamics as we continue to prepare to launch the product in Europe,” said Stuart A. Randle, the company's CEO.

Reporters and editors from Elsevier's “The Pink Sheet” contributed to this column.

JDRF, Animas Ink Deal

The Juvenile Diabetes Research Foundation is collaborating with Animas, a division of Johnson & Johnson, to develop an automated system for insulin delivery—“the first step on the path to … the development of an artificial pancreas,” according to a statement from the JDRF. The first-generation system would be partially automated and would involve an insulin pump connected wirelessly with a continuous glucose monitor. The CGM would transmit its reading to the insulin pump, which would house a sophisticated computer program designed to prevent hypoglycemia and extreme hyperglycemia. The pump would slow or stop insulin delivery if it detected blood sugar was going too low and would increase insulin delivery if blood sugar was too high. DexCom is supplying the CGM technology for the system. If successful, the development of this system “would begin the process of automating how people with diabetes manage their blood sugar,” said Alan Lewis, Ph.D., president and CEO of the JDRF. “Even this early system could bring dramatic changes in the quality of life for the 3 million people in the U.S. with type 1 diabetes, beginning to free kids and adults from testing, calculating, and treating themselves throughout the day.” The JDRF is providing $8 million in funding over 3 years for the project, and aims to have the system ready for regulatory review in about 4 years.

Takeda, Pfizer Market Actos in China

Takeda has signed a copromotion deal with Pfizer to market its Actos type 2 diabetes drug in China. U.S. market exclusivity for Actos (pioglitazone), which generated global sales of over $4 billion in 2008, ends in 2011. China is expected to become the third-largest pharmaceutical market by 2011 and many big drug makers have committed to developing business there, among other promising emerging countries. Pfizer is now the largest drug maker in the country, with 2008 sales of $428 million, a figure analysts project will grow to $1 billion in 2009. For the last 5 years, Takeda has in China been marketing Actos with Tianjin Takeda Pharmaceuticals, a joint venture of Takeda Pharmaceutical Company Limited and Tianjin Lisheng Pharmaceutical Co., a Chinese company. According to the new agreement, which is exclusive, Pfizer will market Actos with the Tianjin joint venture in exchange for an undisclosed cut of sales.

Phenomix Taking Dutogliptin to Europe

A little over a year after partnering with Forest Laboratories to develop the DPP-4 inhibitor dutogliptin for type 2 diabetes in North America, Phenomix has sealed a deal with Chiesi Farmaceutici to commercialize the drug in Europe. The deal is worth up to $28 million in near-term cash and the total value, which includes milestone payments, could reach $163 million. Dutogliptin is now part of a phase III clinical development program that includes five studies of 3,000 patients. The first results are due for release in the second quarter of 2010, according to Forest, which has been Phenomix's partner in North America since October 2008. Milestones in the Chiesi agreement are tied to development and commercialization of dutogliptin in Europe and other territories including Brazil, Russia, and all other members of the Commonwealth of Independent States, Turkey, and North Africa. Chiesi, of Parma, Italy, will be responsible for product development, regulatory approval, and commercialization in the territories covered by the deal. Phenomix, based in San Diego, will also receive an undisclosed cut of sales.

EndoBarrier Gets CE Mark

The EndoBarrier, an investigational gastrointestinal liner designed to mimic the effects of Roux-en-Y gastric bypass, has received CE mark approval for marketing in Europe, the product's maker, GI Dynamics, said in a statement. The EndoBarrier gastrointestinal liner is placed in the GI tract endoscopically to create a barrier between food and the wall of the intestine. The company noted that clinical trials involving more than 270 patients have shown the significant weight loss and diabetes improvement achieved with the EndoBarrier system. “This European approval for 6 months of EndoBarrier therapy to treat type 2 diabetes and obesity is another key milestone for GI Dynamics as we continue to prepare to launch the product in Europe,” said Stuart A. Randle, the company's CEO.

Reporters and editors from Elsevier's “The Pink Sheet” contributed to this column.

JDRF, Animas Ink Deal

The Juvenile Diabetes Research Foundation is collaborating with Animas, a division of Johnson & Johnson, to develop an automated system for insulin delivery—“the first step on the path to … the development of an artificial pancreas,” according to a statement from the JDRF. The first-generation system would be partially automated and would involve an insulin pump connected wirelessly with a continuous glucose monitor. The CGM would transmit its reading to the insulin pump, which would house a sophisticated computer program designed to prevent hypoglycemia and extreme hyperglycemia. The pump would slow or stop insulin delivery if it detected blood sugar was going too low and would increase insulin delivery if blood sugar was too high. DexCom is supplying the CGM technology for the system. If successful, the development of this system “would begin the process of automating how people with diabetes manage their blood sugar,” said Alan Lewis, Ph.D., president and CEO of the JDRF. “Even this early system could bring dramatic changes in the quality of life for the 3 million people in the U.S. with type 1 diabetes, beginning to free kids and adults from testing, calculating, and treating themselves throughout the day.” The JDRF is providing $8 million in funding over 3 years for the project, and aims to have the system ready for regulatory review in about 4 years.

Takeda, Pfizer Market Actos in China

Takeda has signed a copromotion deal with Pfizer to market its Actos type 2 diabetes drug in China. U.S. market exclusivity for Actos (pioglitazone), which generated global sales of over $4 billion in 2008, ends in 2011. China is expected to become the third-largest pharmaceutical market by 2011 and many big drug makers have committed to developing business there, among other promising emerging countries. Pfizer is now the largest drug maker in the country, with 2008 sales of $428 million, a figure analysts project will grow to $1 billion in 2009. For the last 5 years, Takeda has in China been marketing Actos with Tianjin Takeda Pharmaceuticals, a joint venture of Takeda Pharmaceutical Company Limited and Tianjin Lisheng Pharmaceutical Co., a Chinese company. According to the new agreement, which is exclusive, Pfizer will market Actos with the Tianjin joint venture in exchange for an undisclosed cut of sales.

Phenomix Taking Dutogliptin to Europe

A little over a year after partnering with Forest Laboratories to develop the DPP-4 inhibitor dutogliptin for type 2 diabetes in North America, Phenomix has sealed a deal with Chiesi Farmaceutici to commercialize the drug in Europe. The deal is worth up to $28 million in near-term cash and the total value, which includes milestone payments, could reach $163 million. Dutogliptin is now part of a phase III clinical development program that includes five studies of 3,000 patients. The first results are due for release in the second quarter of 2010, according to Forest, which has been Phenomix's partner in North America since October 2008. Milestones in the Chiesi agreement are tied to development and commercialization of dutogliptin in Europe and other territories including Brazil, Russia, and all other members of the Commonwealth of Independent States, Turkey, and North Africa. Chiesi, of Parma, Italy, will be responsible for product development, regulatory approval, and commercialization in the territories covered by the deal. Phenomix, based in San Diego, will also receive an undisclosed cut of sales.

EndoBarrier Gets CE Mark

The EndoBarrier, an investigational gastrointestinal liner designed to mimic the effects of Roux-en-Y gastric bypass, has received CE mark approval for marketing in Europe, the product's maker, GI Dynamics, said in a statement. The EndoBarrier gastrointestinal liner is placed in the GI tract endoscopically to create a barrier between food and the wall of the intestine. The company noted that clinical trials involving more than 270 patients have shown the significant weight loss and diabetes improvement achieved with the EndoBarrier system. “This European approval for 6 months of EndoBarrier therapy to treat type 2 diabetes and obesity is another key milestone for GI Dynamics as we continue to prepare to launch the product in Europe,” said Stuart A. Randle, the company's CEO.

Reporters and editors from Elsevier's “The Pink Sheet” contributed to this column.

Teaching Obesity

What's really causing the obesity epidemic? Just ask George Costanza, the pudgy best friend from TV's “Seinfeld,” or Billy Strean, Ph.D., of the University of Alberta in Edmonton, and they'll give you the same answer: bad gym teachers. George's high school gym teacher gave him a wedgie and called him “Can't-stand-ya,” and just look at what happened. According to Dr. Strean, childhood humiliation in physical education classes can turn people off fitness for good (Qual. Res. Sport Exerc. 2009;1:210-20). Physical education would be more fun, he said, if adults did not overorganize sports and waited until kids entered their teens before focusing on outcomes. By the way, Dr. Strean's curriculum vitae includes, under the heading “Certifications of Jocularity & Mirth,” the title of “Certified Laughter Leader (World Laughter Tour),” so he must know something about fun.

Suntan Smackdown

Just in time for spring break, at a hearing slated for next month the Food and Drug Administration is finally taking a look at the health effects of indoor tanning. Representatives from the Indoor Tanning Association are sure to be there, with a “healthy glow,” no doubt. So what will their defense of ultraviolet radiation be, now that the not-the-same-as-the-sun argument looks as weak the tobacco industry reaching for its last Lucky? One can only imagine how they'll wade through the oceans of evidence against them. But we'll be there to see them try … sipping a piñ colada under a beach umbrella, of course.

Manicures, Martinis, and Babies?

Yes, those things apparently go well together, at least they do according to the American Fertility Association, which sponsored a live infomercial on fertility services at an upscale Beverly Hills nail salon called Bellacures. The very name of the Manicures & Martinis Family Building program begs the question: What will market researchers get away with next? We'd like to wish all those parents- to-be the best of luck changing that 3 a.m. diaper. Hope the polish doesn't smudge.

Teaching Obesity

What's really causing the obesity epidemic? Just ask George Costanza, the pudgy best friend from TV's “Seinfeld,” or Billy Strean, Ph.D., of the University of Alberta in Edmonton, and they'll give you the same answer: bad gym teachers. George's high school gym teacher gave him a wedgie and called him “Can't-stand-ya,” and just look at what happened. According to Dr. Strean, childhood humiliation in physical education classes can turn people off fitness for good (Qual. Res. Sport Exerc. 2009;1:210-20). Physical education would be more fun, he said, if adults did not overorganize sports and waited until kids entered their teens before focusing on outcomes. By the way, Dr. Strean's curriculum vitae includes, under the heading “Certifications of Jocularity & Mirth,” the title of “Certified Laughter Leader (World Laughter Tour),” so he must know something about fun.

Suntan Smackdown

Just in time for spring break, at a hearing slated for next month the Food and Drug Administration is finally taking a look at the health effects of indoor tanning. Representatives from the Indoor Tanning Association are sure to be there, with a “healthy glow,” no doubt. So what will their defense of ultraviolet radiation be, now that the not-the-same-as-the-sun argument looks as weak the tobacco industry reaching for its last Lucky? One can only imagine how they'll wade through the oceans of evidence against them. But we'll be there to see them try … sipping a piñ colada under a beach umbrella, of course.

Manicures, Martinis, and Babies?

Yes, those things apparently go well together, at least they do according to the American Fertility Association, which sponsored a live infomercial on fertility services at an upscale Beverly Hills nail salon called Bellacures. The very name of the Manicures & Martinis Family Building program begs the question: What will market researchers get away with next? We'd like to wish all those parents- to-be the best of luck changing that 3 a.m. diaper. Hope the polish doesn't smudge.

Teaching Obesity

What's really causing the obesity epidemic? Just ask George Costanza, the pudgy best friend from TV's “Seinfeld,” or Billy Strean, Ph.D., of the University of Alberta in Edmonton, and they'll give you the same answer: bad gym teachers. George's high school gym teacher gave him a wedgie and called him “Can't-stand-ya,” and just look at what happened. According to Dr. Strean, childhood humiliation in physical education classes can turn people off fitness for good (Qual. Res. Sport Exerc. 2009;1:210-20). Physical education would be more fun, he said, if adults did not overorganize sports and waited until kids entered their teens before focusing on outcomes. By the way, Dr. Strean's curriculum vitae includes, under the heading “Certifications of Jocularity & Mirth,” the title of “Certified Laughter Leader (World Laughter Tour),” so he must know something about fun.

Suntan Smackdown

Just in time for spring break, at a hearing slated for next month the Food and Drug Administration is finally taking a look at the health effects of indoor tanning. Representatives from the Indoor Tanning Association are sure to be there, with a “healthy glow,” no doubt. So what will their defense of ultraviolet radiation be, now that the not-the-same-as-the-sun argument looks as weak the tobacco industry reaching for its last Lucky? One can only imagine how they'll wade through the oceans of evidence against them. But we'll be there to see them try … sipping a piñ colada under a beach umbrella, of course.

Manicures, Martinis, and Babies?

Yes, those things apparently go well together, at least they do according to the American Fertility Association, which sponsored a live infomercial on fertility services at an upscale Beverly Hills nail salon called Bellacures. The very name of the Manicures & Martinis Family Building program begs the question: What will market researchers get away with next? We'd like to wish all those parents- to-be the best of luck changing that 3 a.m. diaper. Hope the polish doesn't smudge.