From Staff Reports

Amgen Buys Rights to Array Drug

In need of a cash infusion, Array BioPharma has received a $60 million up-front payment from Amgen for worldwide rights to ARRY-403, a phase I glucokinase activator for type 2 diabetes. Glucokinase activators stimulate the pancreas to secrete insulin while increasing the liver's glucose intake and reducing its secretion. The Boulder, Colo.–based biotech firm told investors it would make a deal before year's end. Array has six other homegrown products in clinical development with partners that include Genentech and Celgene. Amgen also has agreed to fund a 2-year research collaboration to identify and advance second-generation glucokinase activator compounds. Array can realize up to $666 million in clinical and commercial milestones, although some are pegged to at least one backup compound reaching market in addition to 403. Array can receive double-digit royalties on sales of 403 should it reach market, and the company retains an option to copromote the drug in the United States.

J&J, Diabetes Group to Collaborate

The Juvenile Diabetes Research Foundation announced that it will work with Johnson & Johnson to speed the development of drugs to promote the survival and function of insulin-producing cells in diabetes patients. The program will fund 1- or 2-year research projects at academic centers around the world that could lead to novel drug targets and industry collaborations for the treatment of type 1 diabetes. “This program will clearly help accelerate the translation of basic research into therapies useful in the treatment of diabetes,” said Alan J. Lewis, Ph.D., JDRF president and CEO. Funding decisions will be led by a combined review committee consisting of representatives from the JDRF and the Johnson & Johnson Corporate Office of Science and Technology and its affiliates, with oversight from a scientific advisory board and JDRF volunteers.

Diagnos Licensed for Retinal Device

Diagnos has received a Health Canada Class 2 Medical Device License for its CARA-CCE (Computer Assisted Retinal Analysis) device, the Brossard, Quebec firm has announced. “Health Canada approval enables us to begin to market and sell our product to support diabetic retinopathy screening,” said Peter Nowacki, the firm's general manager–medical. Company president André Larente noted that “Because diabetics require regular screening for eye disease, we estimate the global value of the retinopathy screening market at $600 million annually. We have established a global sales network and feel confident in our ability to begin to generate revenues with CARA.” CARA performs a proprietary enhancement of retinal images and can automatically highlight areas of possible pathology to the user, according to the company., which noted that “CARA's image enhancement algorithms make standard retinal images sharper, clearer, and easier to read.” It is an automated platform accessible securely over the Internet, and is compatible with all recognized image formats and brands of fundus cameras.

Biocompatibles Begins CM3 Trials

Biocompatibles International will initiate clinical trials for CM3—a type 2 diabetes drug—this month, the company announced in December. Biocompatibles entered into an agreement with AstraZeneca in December 2008 to develop CM3, a glucagon-like peptide-1 (GLP-1) analogue invented by Biocompatibles subsidiary CellMed. The agreement included preclinical, phase I and phase IIa activities managed by CellMed. As part of the development agreement, AstraZeneca will pay Biocompatibles a $6.9 million installment payment, part of a total payment of $14.2 million. The agreement also provides AstraZeneca with an exclusive option to license relevant patents for further exploitation at any time during the course of the development program, which is expected to be completed in 2012. “The first-generation GLP-1s have established the drug class in treating type 2 diabetes but have also shown some limitations,” said Biocompatibles CEO Crispin Simon. “We see CM3 as a second generation GLP-1, which has the potential to overcome these limitations.”

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

Amgen Buys Rights to Array Drug

In need of a cash infusion, Array BioPharma has received a $60 million up-front payment from Amgen for worldwide rights to ARRY-403, a phase I glucokinase activator for type 2 diabetes. Glucokinase activators stimulate the pancreas to secrete insulin while increasing the liver's glucose intake and reducing its secretion. The Boulder, Colo.–based biotech firm told investors it would make a deal before year's end. Array has six other homegrown products in clinical development with partners that include Genentech and Celgene. Amgen also has agreed to fund a 2-year research collaboration to identify and advance second-generation glucokinase activator compounds. Array can realize up to $666 million in clinical and commercial milestones, although some are pegged to at least one backup compound reaching market in addition to 403. Array can receive double-digit royalties on sales of 403 should it reach market, and the company retains an option to copromote the drug in the United States.

J&J, Diabetes Group to Collaborate

The Juvenile Diabetes Research Foundation announced that it will work with Johnson & Johnson to speed the development of drugs to promote the survival and function of insulin-producing cells in diabetes patients. The program will fund 1- or 2-year research projects at academic centers around the world that could lead to novel drug targets and industry collaborations for the treatment of type 1 diabetes. “This program will clearly help accelerate the translation of basic research into therapies useful in the treatment of diabetes,” said Alan J. Lewis, Ph.D., JDRF president and CEO. Funding decisions will be led by a combined review committee consisting of representatives from the JDRF and the Johnson & Johnson Corporate Office of Science and Technology and its affiliates, with oversight from a scientific advisory board and JDRF volunteers.

Diagnos Licensed for Retinal Device

Diagnos has received a Health Canada Class 2 Medical Device License for its CARA-CCE (Computer Assisted Retinal Analysis) device, the Brossard, Quebec firm has announced. “Health Canada approval enables us to begin to market and sell our product to support diabetic retinopathy screening,” said Peter Nowacki, the firm's general manager–medical. Company president André Larente noted that “Because diabetics require regular screening for eye disease, we estimate the global value of the retinopathy screening market at $600 million annually. We have established a global sales network and feel confident in our ability to begin to generate revenues with CARA.” CARA performs a proprietary enhancement of retinal images and can automatically highlight areas of possible pathology to the user, according to the company., which noted that “CARA's image enhancement algorithms make standard retinal images sharper, clearer, and easier to read.” It is an automated platform accessible securely over the Internet, and is compatible with all recognized image formats and brands of fundus cameras.

Biocompatibles Begins CM3 Trials

Biocompatibles International will initiate clinical trials for CM3—a type 2 diabetes drug—this month, the company announced in December. Biocompatibles entered into an agreement with AstraZeneca in December 2008 to develop CM3, a glucagon-like peptide-1 (GLP-1) analogue invented by Biocompatibles subsidiary CellMed. The agreement included preclinical, phase I and phase IIa activities managed by CellMed. As part of the development agreement, AstraZeneca will pay Biocompatibles a $6.9 million installment payment, part of a total payment of $14.2 million. The agreement also provides AstraZeneca with an exclusive option to license relevant patents for further exploitation at any time during the course of the development program, which is expected to be completed in 2012. “The first-generation GLP-1s have established the drug class in treating type 2 diabetes but have also shown some limitations,” said Biocompatibles CEO Crispin Simon. “We see CM3 as a second generation GLP-1, which has the potential to overcome these limitations.”

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

Amgen Buys Rights to Array Drug

In need of a cash infusion, Array BioPharma has received a $60 million up-front payment from Amgen for worldwide rights to ARRY-403, a phase I glucokinase activator for type 2 diabetes. Glucokinase activators stimulate the pancreas to secrete insulin while increasing the liver's glucose intake and reducing its secretion. The Boulder, Colo.–based biotech firm told investors it would make a deal before year's end. Array has six other homegrown products in clinical development with partners that include Genentech and Celgene. Amgen also has agreed to fund a 2-year research collaboration to identify and advance second-generation glucokinase activator compounds. Array can realize up to $666 million in clinical and commercial milestones, although some are pegged to at least one backup compound reaching market in addition to 403. Array can receive double-digit royalties on sales of 403 should it reach market, and the company retains an option to copromote the drug in the United States.

J&J, Diabetes Group to Collaborate

The Juvenile Diabetes Research Foundation announced that it will work with Johnson & Johnson to speed the development of drugs to promote the survival and function of insulin-producing cells in diabetes patients. The program will fund 1- or 2-year research projects at academic centers around the world that could lead to novel drug targets and industry collaborations for the treatment of type 1 diabetes. “This program will clearly help accelerate the translation of basic research into therapies useful in the treatment of diabetes,” said Alan J. Lewis, Ph.D., JDRF president and CEO. Funding decisions will be led by a combined review committee consisting of representatives from the JDRF and the Johnson & Johnson Corporate Office of Science and Technology and its affiliates, with oversight from a scientific advisory board and JDRF volunteers.

Diagnos Licensed for Retinal Device

Diagnos has received a Health Canada Class 2 Medical Device License for its CARA-CCE (Computer Assisted Retinal Analysis) device, the Brossard, Quebec firm has announced. “Health Canada approval enables us to begin to market and sell our product to support diabetic retinopathy screening,” said Peter Nowacki, the firm's general manager–medical. Company president André Larente noted that “Because diabetics require regular screening for eye disease, we estimate the global value of the retinopathy screening market at $600 million annually. We have established a global sales network and feel confident in our ability to begin to generate revenues with CARA.” CARA performs a proprietary enhancement of retinal images and can automatically highlight areas of possible pathology to the user, according to the company., which noted that “CARA's image enhancement algorithms make standard retinal images sharper, clearer, and easier to read.” It is an automated platform accessible securely over the Internet, and is compatible with all recognized image formats and brands of fundus cameras.

Biocompatibles Begins CM3 Trials

Biocompatibles International will initiate clinical trials for CM3—a type 2 diabetes drug—this month, the company announced in December. Biocompatibles entered into an agreement with AstraZeneca in December 2008 to develop CM3, a glucagon-like peptide-1 (GLP-1) analogue invented by Biocompatibles subsidiary CellMed. The agreement included preclinical, phase I and phase IIa activities managed by CellMed. As part of the development agreement, AstraZeneca will pay Biocompatibles a $6.9 million installment payment, part of a total payment of $14.2 million. The agreement also provides AstraZeneca with an exclusive option to license relevant patents for further exploitation at any time during the course of the development program, which is expected to be completed in 2012. “The first-generation GLP-1s have established the drug class in treating type 2 diabetes but have also shown some limitations,” said Biocompatibles CEO Crispin Simon. “We see CM3 as a second generation GLP-1, which has the potential to overcome these limitations.”

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

New Rosuvastatin Indication Backed

The FDA's Endocrinologic and Metabolic Drugs Advisory Committee voted 12–4, with 1 abstention, that data support the use of rosuvastatin for the primary prevention of major cardiovascular adverse events in men aged 50 years and older and in women aged 60 years and older with a fasting LDL cholesterol level below 130 mg/dL, high-sensitivity C-reactive protein (hsCRP) level of 2.0 mg/L or more, triglyceride level below 500 mg/dL, and no prior history of cardiovascular events or disease.

Those criteria are based on a multinational, randomized placebo-controlled study of 17,802 people who did not have hyperlipidemia but did have an elevated level of hsCRP. The study was stopped early because of the positive results (N. Engl. J. Med. 2008;359:2195–207).

The panel was not asked specifically to vote on whether to approve rosuvastatin for the indication.

AstraZeneca markets rosuvastatin as Crestor. First approved in 2003, rosuvastatin has been approved for several indications, most related to lipid lowering.

Three safety issues were raised by the FDA reviewers: a greater number of deaths due to gastrointestinal disorders, confusion-related events, and a significant increase in investigator-diagnosed cases of diabetes among the patients in the rosuvastatin arm.

Diclofenac Hepatotoxicity Cited

Warnings about potential hepatotoxicity associated with the use of diclofenac have been added to the labels of all products containing the NSAID, the FDA announced.

A notice posted on the FDA's MedWatch site said that the manufacturers—Endo Pharmaceuticals and Novartis Consumer Health—had revised the “hepatic effects” section of the diclofenac topical gel label to include new warnings and precautions.

There have been postmarketing reports of severe hepatic reactions, including liver necrosis, jaundice, fulminant hepatitis with and without jaundice, and liver failure, according to the FDA. Some of the cases have been fatal or resulted in liver transplantation.

Because a patient may develop severe hepatoxicity without symptoms, clinicians should periodically measure transaminase levels in patients taking diclofenac long-term. Levels should be monitored within 4–8 weeks after initiating treatment, according to the FDA notice.

Desipramine Gets Safety Warnings

Warnings related to the risk of sudden death and cardiac dysrhythmias associated with desipramine have been added to the label of the tricyclic antidepressant, according to the FDA.

A notice on the FDA's MedWatch site states that “extreme caution” should be used when desipramine is prescribed to patients who have a family history of sudden death, cardiac dysrhythmias, and cardiac conduction disturbances. Also added is the statement that “seizures precede cardiac dysrhythmias and death in some patients.”

Desipramine, approved in 1964, is marketed as Norpramin by Sanofi-Aventis, which issued a Dear Healthcare Professional letter about the label changes.

Panel Backs New Tiotropium Claim

An FDA advisory panel voted 11–1 that data from two studies provided enough evidence to support approval of a claim that treatment with the inhaled, dry-powder formulation of tiotropium reduces exacerbations in patients with chronic obstructive pulmonary disease.

The FDA's Pulmonary-Allergy Drugs Advisory Committee also voted 11–1 that data from the Understanding Potential Long-Term Impacts on Function with Tiotropium (UPLIFT) trial, “adequately addressed” the potential safety signals of an increased risk of stroke and adverse cardiovascular outcomes identified in pooled data and meta-analyses.

The dry-powder formulation of tiotropium, marketed as the Spiriva HandiHaler by Boehringer Ingelheim and Pfizer, was approved in the United States in 2004 for long-term maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disorder, including chronic bronchitis and emphysema. Administered once daily, each inhalation contains 18 mcg of tiotropium, an anticholinergic.

Sibutramine Tied to Cardiac Events

As part of an ongoing safety review of the weight-loss drug sibutramine, the FDA is looking at recent data suggesting a higher cardiovascular event rate with the medication, compared with placebo.

A statement on the agency's MedWatch site notes these preliminary findings “highlight the importance of avoiding the use of sibutramine” in patients with coronary artery disease, heart failure, arrhythmias, or stroke, as recommended in the current sibutramine label.

Sibutramine is marketed as Meridia by Abbott Laboratories. It was approved in 1997 for the management of obesity, including weight loss in conjunction with a reduced-calorie diet, and is recommended only for obese patients.

The FDA reported preliminary results from about 10,000 patients aged 55 years or older. Events in the study's primary end point—MI, stroke, resuscitated cardiac arrest, or death—were reported in 11.4% of those on sibutramine and in 10% of those on placebo. The FDA described the difference as “higher than expected, suggesting that sibutramine is associated with an increased cardiovascular risk in the study population.”

Valproate Teratogenicity Highlighted

The high risk of neural tube defects and other major malformations in babies exposed during the first trimester to valproate sodium and the related products, valproic acid and divalproex sodium, is the focus of an FDA notice.

The risk of a neural tube defect in a baby born to a mother who took valproate or one of the two related products during the first 12 weeks of pregnancy is 1 in 20, compared with the U.S. background rate of 1 in 1,500, and the major malformation rate in babies is nearly fourfold greater with valproate than with a different antiepileptic: 10.7% vs. 2.9%.

Marketed as Depakene and as Stavzor, valproic acid was approved in 1978 for treating epilepsy. Valproate, marketed as Depacon, was approved more recently for treating bipolar disorder and migraine headaches. Divalproex sodium, marketed as Depakote, Depakote CP, and Depakote ER, is approved for migraine prophylaxis, manic episodes associated with bipolar disorder, and epilepsy.

Inhaled Antibiotic Eyed for Use in CF

Studies of an inhaled formulation of the monobactam antibiotic aztreonam in patients with cystic fibrosis show that it is a safe and effective treatment for Pseudomonas aeruginosa lung infections in this population, a federal advisory panel concluded in a 15–2 vote.

The FDA's Anti-Infective Drugs Advisory Committee found that the manufacturer, Gilead Sciences, had provided substantial evidence that inhaled aztreonam, administered at a dose of 75 mg three times a day for 28 days, was safe and effective for the proposed indication: improvement of respiratory symptoms and pulmonary function in patients who have cystic fibrosis with P. aeruginosa. If approved, the company plans to market it as Cayston, along with a novel, portable handheld nebulizer. The panel was not asked to vote specifically on whether to recommend approval.

Inhaled aztreonam has been approved for this indication in the European Union, Canada, and other countries. The intravenous formulation was approved in 1986 in the United States for indications that include P. aeruginosa infections, but not specifically for CF patients.

New Rosuvastatin Indication Backed

The FDA's Endocrinologic and Metabolic Drugs Advisory Committee voted 12–4, with 1 abstention, that data support the use of rosuvastatin for the primary prevention of major cardiovascular adverse events in men aged 50 years and older and in women aged 60 years and older with a fasting LDL cholesterol level below 130 mg/dL, high-sensitivity C-reactive protein (hsCRP) level of 2.0 mg/L or more, triglyceride level below 500 mg/dL, and no prior history of cardiovascular events or disease.

Those criteria are based on a multinational, randomized placebo-controlled study of 17,802 people who did not have hyperlipidemia but did have an elevated level of hsCRP. The study was stopped early because of the positive results (N. Engl. J. Med. 2008;359:2195–207).

The panel was not asked specifically to vote on whether to approve rosuvastatin for the indication.

AstraZeneca markets rosuvastatin as Crestor. First approved in 2003, rosuvastatin has been approved for several indications, most related to lipid lowering.

Three safety issues were raised by the FDA reviewers: a greater number of deaths due to gastrointestinal disorders, confusion-related events, and a significant increase in investigator-diagnosed cases of diabetes among the patients in the rosuvastatin arm.

Diclofenac Hepatotoxicity Cited

Warnings about potential hepatotoxicity associated with the use of diclofenac have been added to the labels of all products containing the NSAID, the FDA announced.

A notice posted on the FDA's MedWatch site said that the manufacturers—Endo Pharmaceuticals and Novartis Consumer Health—had revised the “hepatic effects” section of the diclofenac topical gel label to include new warnings and precautions.

There have been postmarketing reports of severe hepatic reactions, including liver necrosis, jaundice, fulminant hepatitis with and without jaundice, and liver failure, according to the FDA. Some of the cases have been fatal or resulted in liver transplantation.

Because a patient may develop severe hepatoxicity without symptoms, clinicians should periodically measure transaminase levels in patients taking diclofenac long-term. Levels should be monitored within 4–8 weeks after initiating treatment, according to the FDA notice.

Desipramine Gets Safety Warnings

Warnings related to the risk of sudden death and cardiac dysrhythmias associated with desipramine have been added to the label of the tricyclic antidepressant, according to the FDA.

A notice on the FDA's MedWatch site states that “extreme caution” should be used when desipramine is prescribed to patients who have a family history of sudden death, cardiac dysrhythmias, and cardiac conduction disturbances. Also added is the statement that “seizures precede cardiac dysrhythmias and death in some patients.”

Desipramine, approved in 1964, is marketed as Norpramin by Sanofi-Aventis, which issued a Dear Healthcare Professional letter about the label changes.

Panel Backs New Tiotropium Claim

An FDA advisory panel voted 11–1 that data from two studies provided enough evidence to support approval of a claim that treatment with the inhaled, dry-powder formulation of tiotropium reduces exacerbations in patients with chronic obstructive pulmonary disease.

The FDA's Pulmonary-Allergy Drugs Advisory Committee also voted 11–1 that data from the Understanding Potential Long-Term Impacts on Function with Tiotropium (UPLIFT) trial, “adequately addressed” the potential safety signals of an increased risk of stroke and adverse cardiovascular outcomes identified in pooled data and meta-analyses.

The dry-powder formulation of tiotropium, marketed as the Spiriva HandiHaler by Boehringer Ingelheim and Pfizer, was approved in the United States in 2004 for long-term maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disorder, including chronic bronchitis and emphysema. Administered once daily, each inhalation contains 18 mcg of tiotropium, an anticholinergic.

Sibutramine Tied to Cardiac Events

As part of an ongoing safety review of the weight-loss drug sibutramine, the FDA is looking at recent data suggesting a higher cardiovascular event rate with the medication, compared with placebo.

A statement on the agency's MedWatch site notes these preliminary findings “highlight the importance of avoiding the use of sibutramine” in patients with coronary artery disease, heart failure, arrhythmias, or stroke, as recommended in the current sibutramine label.

Sibutramine is marketed as Meridia by Abbott Laboratories. It was approved in 1997 for the management of obesity, including weight loss in conjunction with a reduced-calorie diet, and is recommended only for obese patients.

The FDA reported preliminary results from about 10,000 patients aged 55 years or older. Events in the study's primary end point—MI, stroke, resuscitated cardiac arrest, or death—were reported in 11.4% of those on sibutramine and in 10% of those on placebo. The FDA described the difference as “higher than expected, suggesting that sibutramine is associated with an increased cardiovascular risk in the study population.”

Valproate Teratogenicity Highlighted

The high risk of neural tube defects and other major malformations in babies exposed during the first trimester to valproate sodium and the related products, valproic acid and divalproex sodium, is the focus of an FDA notice.

The risk of a neural tube defect in a baby born to a mother who took valproate or one of the two related products during the first 12 weeks of pregnancy is 1 in 20, compared with the U.S. background rate of 1 in 1,500, and the major malformation rate in babies is nearly fourfold greater with valproate than with a different antiepileptic: 10.7% vs. 2.9%.

Marketed as Depakene and as Stavzor, valproic acid was approved in 1978 for treating epilepsy. Valproate, marketed as Depacon, was approved more recently for treating bipolar disorder and migraine headaches. Divalproex sodium, marketed as Depakote, Depakote CP, and Depakote ER, is approved for migraine prophylaxis, manic episodes associated with bipolar disorder, and epilepsy.

Inhaled Antibiotic Eyed for Use in CF

Studies of an inhaled formulation of the monobactam antibiotic aztreonam in patients with cystic fibrosis show that it is a safe and effective treatment for Pseudomonas aeruginosa lung infections in this population, a federal advisory panel concluded in a 15–2 vote.

The FDA's Anti-Infective Drugs Advisory Committee found that the manufacturer, Gilead Sciences, had provided substantial evidence that inhaled aztreonam, administered at a dose of 75 mg three times a day for 28 days, was safe and effective for the proposed indication: improvement of respiratory symptoms and pulmonary function in patients who have cystic fibrosis with P. aeruginosa. If approved, the company plans to market it as Cayston, along with a novel, portable handheld nebulizer. The panel was not asked to vote specifically on whether to recommend approval.

Inhaled aztreonam has been approved for this indication in the European Union, Canada, and other countries. The intravenous formulation was approved in 1986 in the United States for indications that include P. aeruginosa infections, but not specifically for CF patients.

New Rosuvastatin Indication Backed

The FDA's Endocrinologic and Metabolic Drugs Advisory Committee voted 12–4, with 1 abstention, that data support the use of rosuvastatin for the primary prevention of major cardiovascular adverse events in men aged 50 years and older and in women aged 60 years and older with a fasting LDL cholesterol level below 130 mg/dL, high-sensitivity C-reactive protein (hsCRP) level of 2.0 mg/L or more, triglyceride level below 500 mg/dL, and no prior history of cardiovascular events or disease.

Those criteria are based on a multinational, randomized placebo-controlled study of 17,802 people who did not have hyperlipidemia but did have an elevated level of hsCRP. The study was stopped early because of the positive results (N. Engl. J. Med. 2008;359:2195–207).

The panel was not asked specifically to vote on whether to approve rosuvastatin for the indication.

AstraZeneca markets rosuvastatin as Crestor. First approved in 2003, rosuvastatin has been approved for several indications, most related to lipid lowering.

Three safety issues were raised by the FDA reviewers: a greater number of deaths due to gastrointestinal disorders, confusion-related events, and a significant increase in investigator-diagnosed cases of diabetes among the patients in the rosuvastatin arm.

Diclofenac Hepatotoxicity Cited

Warnings about potential hepatotoxicity associated with the use of diclofenac have been added to the labels of all products containing the NSAID, the FDA announced.

A notice posted on the FDA's MedWatch site said that the manufacturers—Endo Pharmaceuticals and Novartis Consumer Health—had revised the “hepatic effects” section of the diclofenac topical gel label to include new warnings and precautions.

There have been postmarketing reports of severe hepatic reactions, including liver necrosis, jaundice, fulminant hepatitis with and without jaundice, and liver failure, according to the FDA. Some of the cases have been fatal or resulted in liver transplantation.

Because a patient may develop severe hepatoxicity without symptoms, clinicians should periodically measure transaminase levels in patients taking diclofenac long-term. Levels should be monitored within 4–8 weeks after initiating treatment, according to the FDA notice.

Desipramine Gets Safety Warnings

Warnings related to the risk of sudden death and cardiac dysrhythmias associated with desipramine have been added to the label of the tricyclic antidepressant, according to the FDA.

A notice on the FDA's MedWatch site states that “extreme caution” should be used when desipramine is prescribed to patients who have a family history of sudden death, cardiac dysrhythmias, and cardiac conduction disturbances. Also added is the statement that “seizures precede cardiac dysrhythmias and death in some patients.”

Desipramine, approved in 1964, is marketed as Norpramin by Sanofi-Aventis, which issued a Dear Healthcare Professional letter about the label changes.

Panel Backs New Tiotropium Claim

An FDA advisory panel voted 11–1 that data from two studies provided enough evidence to support approval of a claim that treatment with the inhaled, dry-powder formulation of tiotropium reduces exacerbations in patients with chronic obstructive pulmonary disease.

The FDA's Pulmonary-Allergy Drugs Advisory Committee also voted 11–1 that data from the Understanding Potential Long-Term Impacts on Function with Tiotropium (UPLIFT) trial, “adequately addressed” the potential safety signals of an increased risk of stroke and adverse cardiovascular outcomes identified in pooled data and meta-analyses.

The dry-powder formulation of tiotropium, marketed as the Spiriva HandiHaler by Boehringer Ingelheim and Pfizer, was approved in the United States in 2004 for long-term maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disorder, including chronic bronchitis and emphysema. Administered once daily, each inhalation contains 18 mcg of tiotropium, an anticholinergic.

Sibutramine Tied to Cardiac Events

As part of an ongoing safety review of the weight-loss drug sibutramine, the FDA is looking at recent data suggesting a higher cardiovascular event rate with the medication, compared with placebo.

A statement on the agency's MedWatch site notes these preliminary findings “highlight the importance of avoiding the use of sibutramine” in patients with coronary artery disease, heart failure, arrhythmias, or stroke, as recommended in the current sibutramine label.

Sibutramine is marketed as Meridia by Abbott Laboratories. It was approved in 1997 for the management of obesity, including weight loss in conjunction with a reduced-calorie diet, and is recommended only for obese patients.

The FDA reported preliminary results from about 10,000 patients aged 55 years or older. Events in the study's primary end point—MI, stroke, resuscitated cardiac arrest, or death—were reported in 11.4% of those on sibutramine and in 10% of those on placebo. The FDA described the difference as “higher than expected, suggesting that sibutramine is associated with an increased cardiovascular risk in the study population.”

Valproate Teratogenicity Highlighted

The high risk of neural tube defects and other major malformations in babies exposed during the first trimester to valproate sodium and the related products, valproic acid and divalproex sodium, is the focus of an FDA notice.

The risk of a neural tube defect in a baby born to a mother who took valproate or one of the two related products during the first 12 weeks of pregnancy is 1 in 20, compared with the U.S. background rate of 1 in 1,500, and the major malformation rate in babies is nearly fourfold greater with valproate than with a different antiepileptic: 10.7% vs. 2.9%.

Marketed as Depakene and as Stavzor, valproic acid was approved in 1978 for treating epilepsy. Valproate, marketed as Depacon, was approved more recently for treating bipolar disorder and migraine headaches. Divalproex sodium, marketed as Depakote, Depakote CP, and Depakote ER, is approved for migraine prophylaxis, manic episodes associated with bipolar disorder, and epilepsy.

Inhaled Antibiotic Eyed for Use in CF

Studies of an inhaled formulation of the monobactam antibiotic aztreonam in patients with cystic fibrosis show that it is a safe and effective treatment for Pseudomonas aeruginosa lung infections in this population, a federal advisory panel concluded in a 15–2 vote.

The FDA's Anti-Infective Drugs Advisory Committee found that the manufacturer, Gilead Sciences, had provided substantial evidence that inhaled aztreonam, administered at a dose of 75 mg three times a day for 28 days, was safe and effective for the proposed indication: improvement of respiratory symptoms and pulmonary function in patients who have cystic fibrosis with P. aeruginosa. If approved, the company plans to market it as Cayston, along with a novel, portable handheld nebulizer. The panel was not asked to vote specifically on whether to recommend approval.

Inhaled aztreonam has been approved for this indication in the European Union, Canada, and other countries. The intravenous formulation was approved in 1986 in the United States for indications that include P. aeruginosa infections, but not specifically for CF patients.

Genzyme, FDA Warn of Contamination

Genzyme and the Food and Drug Administration have issued warnings to patients and health care providers that certain lots of five biological drugs, including Thyrogen, have been found to be contaminated with a variety of foreign particles. Physicians have been directed to visually inspect the vials of the products in question before use and also to filter the products to ensure the removal of possible foreign particles. This latest contamination warning is yet another blow to the credibility of Genzyme's management team, which in June was forced to temporarily shut down the company's Allston, Mass., plant because of bioreactor contamination. The facility resumed production in August, and Genzyme asserts that the current problem is not related to recent efforts to decontaminate the plant. Nonetheless, all five of the products in question—Cerezyme, Fabrazyme, Myozyme, Aldurazyme, and Thyrogen—are manufactured and/or finished and filled at the Allston plant. The Cambridge, Mass.–based company asks that vials observed to contain foreign particles be reported via a toll-free telephone number and returned to Genzyme; no adverse events related to the contamination have been reported.

Integrated Diagnostics Gets Financing

Integrated Diagnostics, a start-up diagnostics developer debuts with the support of a $30 million “Series A” financing round, led by InterWest Partners. The Seattle firm is developing genomic and proteomic technologies to identify organ-specific proteins and enable the diagnosis and prognosis of a variety of diseases. Areas of focus include personalized and preventive diagnostics for cancer, diabetes, and Alzheimer's disease.

“Integrated Diagnostics' research enabling technologies will allow us to cut in half the standard development times for diagnostics,” said company founder Leroy Hood. Launched Oct. 14, Integrated Diagnostics is an outgrowth of a public-private partnership between the nation of Luxembourg and several American research institutions, including the Seattle-based Institute for Systems Biology.

Tethys to Expand Rollout

Privately-held Tethys Bioscience is set to expand the rollout of its PreDx Diabetes Risk Score test, after securing $25 million in new financing. Previously, since its 2005 founding, the company had raised more than $54 million in financing. The test, which Tethys says helps identify those most at risk of developing type 2 diabetes, measures several biomarkers in a patient's blood sample, puts the results through an algorithm, and scores risk of developing diabetes within 5 years. Doctors can work with those at highest risk to prevent the onset of disease, according to the company. Launched in January 2009, the product is now available only from the company's California laboratory.

Tethys is in negotiations with a range of larger diagnostic players, including LabCorp, regarding a potential licensing deal that would make the test more widely available.

Takeda, Amylin Sign Deal

Takeda and Amylin have teamed up to develop and commercialize several obesity candidates, including pramlintide/metreleptin and davalintide, the companies have announced. The deal includes additional compounds from both companies' research pipelines. Under the arrangement with Takeda, Amylin will receive $75 million up front. Development and sales milestones across the multiple programs could total more than $1 billion. The deal calls for development milestones up to $200 million for two specific products and up to $50 million for any additional products. Commercial milestones are $140 million per product related to first sale of the products and up to $800 million per product for other sales-based milestones. Amylin is also eligible for double-digit royalties on sales. Amylin will be responsible for development of potential candidates through phase II for regulatory approval in the United States, while Takeda will lead development beyond phase II in the United States and elsewhere. Amylin will be responsible for paying 20% of development costs within the United States, while Takeda will be responsible for 80% of costs nationally and 100% of costs outside the country.

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

Genzyme, FDA Warn of Contamination

Genzyme and the Food and Drug Administration have issued warnings to patients and health care providers that certain lots of five biological drugs, including Thyrogen, have been found to be contaminated with a variety of foreign particles. Physicians have been directed to visually inspect the vials of the products in question before use and also to filter the products to ensure the removal of possible foreign particles. This latest contamination warning is yet another blow to the credibility of Genzyme's management team, which in June was forced to temporarily shut down the company's Allston, Mass., plant because of bioreactor contamination. The facility resumed production in August, and Genzyme asserts that the current problem is not related to recent efforts to decontaminate the plant. Nonetheless, all five of the products in question—Cerezyme, Fabrazyme, Myozyme, Aldurazyme, and Thyrogen—are manufactured and/or finished and filled at the Allston plant. The Cambridge, Mass.–based company asks that vials observed to contain foreign particles be reported via a toll-free telephone number and returned to Genzyme; no adverse events related to the contamination have been reported.

Integrated Diagnostics Gets Financing

Integrated Diagnostics, a start-up diagnostics developer debuts with the support of a $30 million “Series A” financing round, led by InterWest Partners. The Seattle firm is developing genomic and proteomic technologies to identify organ-specific proteins and enable the diagnosis and prognosis of a variety of diseases. Areas of focus include personalized and preventive diagnostics for cancer, diabetes, and Alzheimer's disease.

“Integrated Diagnostics' research enabling technologies will allow us to cut in half the standard development times for diagnostics,” said company founder Leroy Hood. Launched Oct. 14, Integrated Diagnostics is an outgrowth of a public-private partnership between the nation of Luxembourg and several American research institutions, including the Seattle-based Institute for Systems Biology.

Tethys to Expand Rollout

Privately-held Tethys Bioscience is set to expand the rollout of its PreDx Diabetes Risk Score test, after securing $25 million in new financing. Previously, since its 2005 founding, the company had raised more than $54 million in financing. The test, which Tethys says helps identify those most at risk of developing type 2 diabetes, measures several biomarkers in a patient's blood sample, puts the results through an algorithm, and scores risk of developing diabetes within 5 years. Doctors can work with those at highest risk to prevent the onset of disease, according to the company. Launched in January 2009, the product is now available only from the company's California laboratory.

Tethys is in negotiations with a range of larger diagnostic players, including LabCorp, regarding a potential licensing deal that would make the test more widely available.

Takeda, Amylin Sign Deal

Takeda and Amylin have teamed up to develop and commercialize several obesity candidates, including pramlintide/metreleptin and davalintide, the companies have announced. The deal includes additional compounds from both companies' research pipelines. Under the arrangement with Takeda, Amylin will receive $75 million up front. Development and sales milestones across the multiple programs could total more than $1 billion. The deal calls for development milestones up to $200 million for two specific products and up to $50 million for any additional products. Commercial milestones are $140 million per product related to first sale of the products and up to $800 million per product for other sales-based milestones. Amylin is also eligible for double-digit royalties on sales. Amylin will be responsible for development of potential candidates through phase II for regulatory approval in the United States, while Takeda will lead development beyond phase II in the United States and elsewhere. Amylin will be responsible for paying 20% of development costs within the United States, while Takeda will be responsible for 80% of costs nationally and 100% of costs outside the country.

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

Genzyme, FDA Warn of Contamination

Genzyme and the Food and Drug Administration have issued warnings to patients and health care providers that certain lots of five biological drugs, including Thyrogen, have been found to be contaminated with a variety of foreign particles. Physicians have been directed to visually inspect the vials of the products in question before use and also to filter the products to ensure the removal of possible foreign particles. This latest contamination warning is yet another blow to the credibility of Genzyme's management team, which in June was forced to temporarily shut down the company's Allston, Mass., plant because of bioreactor contamination. The facility resumed production in August, and Genzyme asserts that the current problem is not related to recent efforts to decontaminate the plant. Nonetheless, all five of the products in question—Cerezyme, Fabrazyme, Myozyme, Aldurazyme, and Thyrogen—are manufactured and/or finished and filled at the Allston plant. The Cambridge, Mass.–based company asks that vials observed to contain foreign particles be reported via a toll-free telephone number and returned to Genzyme; no adverse events related to the contamination have been reported.

Integrated Diagnostics Gets Financing

Integrated Diagnostics, a start-up diagnostics developer debuts with the support of a $30 million “Series A” financing round, led by InterWest Partners. The Seattle firm is developing genomic and proteomic technologies to identify organ-specific proteins and enable the diagnosis and prognosis of a variety of diseases. Areas of focus include personalized and preventive diagnostics for cancer, diabetes, and Alzheimer's disease.

“Integrated Diagnostics' research enabling technologies will allow us to cut in half the standard development times for diagnostics,” said company founder Leroy Hood. Launched Oct. 14, Integrated Diagnostics is an outgrowth of a public-private partnership between the nation of Luxembourg and several American research institutions, including the Seattle-based Institute for Systems Biology.

Tethys to Expand Rollout

Privately-held Tethys Bioscience is set to expand the rollout of its PreDx Diabetes Risk Score test, after securing $25 million in new financing. Previously, since its 2005 founding, the company had raised more than $54 million in financing. The test, which Tethys says helps identify those most at risk of developing type 2 diabetes, measures several biomarkers in a patient's blood sample, puts the results through an algorithm, and scores risk of developing diabetes within 5 years. Doctors can work with those at highest risk to prevent the onset of disease, according to the company. Launched in January 2009, the product is now available only from the company's California laboratory.

Tethys is in negotiations with a range of larger diagnostic players, including LabCorp, regarding a potential licensing deal that would make the test more widely available.

Takeda, Amylin Sign Deal

Takeda and Amylin have teamed up to develop and commercialize several obesity candidates, including pramlintide/metreleptin and davalintide, the companies have announced. The deal includes additional compounds from both companies' research pipelines. Under the arrangement with Takeda, Amylin will receive $75 million up front. Development and sales milestones across the multiple programs could total more than $1 billion. The deal calls for development milestones up to $200 million for two specific products and up to $50 million for any additional products. Commercial milestones are $140 million per product related to first sale of the products and up to $800 million per product for other sales-based milestones. Amylin is also eligible for double-digit royalties on sales. Amylin will be responsible for development of potential candidates through phase II for regulatory approval in the United States, while Takeda will lead development beyond phase II in the United States and elsewhere. Amylin will be responsible for paying 20% of development costs within the United States, while Takeda will be responsible for 80% of costs nationally and 100% of costs outside the country.

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

Ligand to Buy Metabasis

Ligand Pharmaceuticals has agreed to acquire the troubled biotechnology company Metabasis Therapeutics, the two companies have announced. At the close of the transaction, Metabasis stockholders will receive a cash payment of $3.2 million minus its estimated net liabilities; Metabasis currently estimates the closing payment at $1.8 million. In addition, its stockholders will receive cash payments as frequently as every 6 months from proceeds of the sale or partnering of any of the Metabasis drug development programs. In recent months, Metabasis, which is developing treatments for diabetes and hyperlipidemia, had been delisted from the NASDAQ stock exchange, and its CEO had left for a position at Merck & Co.

Merck Begins Payment Disclosures

Merck & Co. paid physicians and medical professionals $3.7 million in 2009's third quarter, according to the company's Web site. Merck's total third-quarter payments are a sixth of those of its rival, Eli Lilly & Co.; the difference may have been due in part to the summer vacation season. But there might be other reasons. The physician receiving the top payment from Merck, for example, took in $22,600, far below the $70,000 received by Lilly's highest paid speaker. Merck's average payment per program was $1,548 and the maximum number of programs for any one speaker was 11. Lilly's speakers racked up far more speaking engagements; its top earners gave more than 40 lectures.

Sanofi, Wellstat Ink Pact

Sanofi-Aventis has signed a licensing deal for global rights to a first-in-class oral insulin sensitizer, PN2034, for treatment of type 2 diabetes. PN2034 restores responsiveness to insulin and enhances insulin action in the liver, according to Sanofi and its licensor, Wellstat Therapeutics. The molecule works through an undisclosed target distinct from that of best-selling insulin sensitizers already on the market, such as GlaxoSmithKline's Avandia (rosiglitazone) and Takeda's Actos (pioglitazone). “PN2034 has the potential to be used across the entire spectrum of [diabetes] patients,” Michael Bamat, Wellstat's vice president for research and development, said in an interview. Sanofi will pay an undisclosed up front fee to Wellstat. The total valueof the deal could reach as high as $350 million.

Saxagliptin Okayed in Europe

Bristol Myers-Squibb and AstraZeneca's dipeptidyl peptidase-4 inhibitor Onglyza (saxagliptin) is set to launch in Europe in early 2010 after being officially cleared for treatment of type 2 diabetes. A once-daily 5-mg dose of the oral drug was cleared by the European Commission as an add-on therapy with the common diabetes treatments metformin, sulfonylureas, and thiazolidinediones, the companies announced last month. An “add-on” indication in Europe contrasts with the wider label in the United States, where Onglyza can be used solo. The Food and Drug Administration approved the product in late July as an adjunct to diet and exercise for improving glycemic control in adults with type 2 diabetes.

Myriad Finds IND Candidate

Myriad Pharmaceuticals Inc. has identified an investigational drug candidate targeting a novel molecular target, the protein kinase IKK epsilon. Inhibitors of IKK epsilon are expected to have significant potential for the treatment of obesity, diabetes, and associated diseases. Myriad's IND candidate, MPI-0485520, is a selective and potent inhibitor of IKK epsilon, with both in vitro and in vivo biological activity. “MPI-0485520 represents a potentially very large commercial opportunity for Myriad Pharmaceuticals,” said Myriad president and CEO Adrian N. Hobden, Ph.D.

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

Ligand to Buy Metabasis

Ligand Pharmaceuticals has agreed to acquire the troubled biotechnology company Metabasis Therapeutics, the two companies have announced. At the close of the transaction, Metabasis stockholders will receive a cash payment of $3.2 million minus its estimated net liabilities; Metabasis currently estimates the closing payment at $1.8 million. In addition, its stockholders will receive cash payments as frequently as every 6 months from proceeds of the sale or partnering of any of the Metabasis drug development programs. In recent months, Metabasis, which is developing treatments for diabetes and hyperlipidemia, had been delisted from the NASDAQ stock exchange, and its CEO had left for a position at Merck & Co.

Merck Begins Payment Disclosures

Merck & Co. paid physicians and medical professionals $3.7 million in 2009's third quarter, according to the company's Web site. Merck's total third-quarter payments are a sixth of those of its rival, Eli Lilly & Co.; the difference may have been due in part to the summer vacation season. But there might be other reasons. The physician receiving the top payment from Merck, for example, took in $22,600, far below the $70,000 received by Lilly's highest paid speaker. Merck's average payment per program was $1,548 and the maximum number of programs for any one speaker was 11. Lilly's speakers racked up far more speaking engagements; its top earners gave more than 40 lectures.

Sanofi, Wellstat Ink Pact

Sanofi-Aventis has signed a licensing deal for global rights to a first-in-class oral insulin sensitizer, PN2034, for treatment of type 2 diabetes. PN2034 restores responsiveness to insulin and enhances insulin action in the liver, according to Sanofi and its licensor, Wellstat Therapeutics. The molecule works through an undisclosed target distinct from that of best-selling insulin sensitizers already on the market, such as GlaxoSmithKline's Avandia (rosiglitazone) and Takeda's Actos (pioglitazone). “PN2034 has the potential to be used across the entire spectrum of [diabetes] patients,” Michael Bamat, Wellstat's vice president for research and development, said in an interview. Sanofi will pay an undisclosed up front fee to Wellstat. The total valueof the deal could reach as high as $350 million.

Saxagliptin Okayed in Europe

Bristol Myers-Squibb and AstraZeneca's dipeptidyl peptidase-4 inhibitor Onglyza (saxagliptin) is set to launch in Europe in early 2010 after being officially cleared for treatment of type 2 diabetes. A once-daily 5-mg dose of the oral drug was cleared by the European Commission as an add-on therapy with the common diabetes treatments metformin, sulfonylureas, and thiazolidinediones, the companies announced last month. An “add-on” indication in Europe contrasts with the wider label in the United States, where Onglyza can be used solo. The Food and Drug Administration approved the product in late July as an adjunct to diet and exercise for improving glycemic control in adults with type 2 diabetes.

Myriad Finds IND Candidate

Myriad Pharmaceuticals Inc. has identified an investigational drug candidate targeting a novel molecular target, the protein kinase IKK epsilon. Inhibitors of IKK epsilon are expected to have significant potential for the treatment of obesity, diabetes, and associated diseases. Myriad's IND candidate, MPI-0485520, is a selective and potent inhibitor of IKK epsilon, with both in vitro and in vivo biological activity. “MPI-0485520 represents a potentially very large commercial opportunity for Myriad Pharmaceuticals,” said Myriad president and CEO Adrian N. Hobden, Ph.D.

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

Ligand to Buy Metabasis

Ligand Pharmaceuticals has agreed to acquire the troubled biotechnology company Metabasis Therapeutics, the two companies have announced. At the close of the transaction, Metabasis stockholders will receive a cash payment of $3.2 million minus its estimated net liabilities; Metabasis currently estimates the closing payment at $1.8 million. In addition, its stockholders will receive cash payments as frequently as every 6 months from proceeds of the sale or partnering of any of the Metabasis drug development programs. In recent months, Metabasis, which is developing treatments for diabetes and hyperlipidemia, had been delisted from the NASDAQ stock exchange, and its CEO had left for a position at Merck & Co.

Merck Begins Payment Disclosures

Merck & Co. paid physicians and medical professionals $3.7 million in 2009's third quarter, according to the company's Web site. Merck's total third-quarter payments are a sixth of those of its rival, Eli Lilly & Co.; the difference may have been due in part to the summer vacation season. But there might be other reasons. The physician receiving the top payment from Merck, for example, took in $22,600, far below the $70,000 received by Lilly's highest paid speaker. Merck's average payment per program was $1,548 and the maximum number of programs for any one speaker was 11. Lilly's speakers racked up far more speaking engagements; its top earners gave more than 40 lectures.

Sanofi, Wellstat Ink Pact

Sanofi-Aventis has signed a licensing deal for global rights to a first-in-class oral insulin sensitizer, PN2034, for treatment of type 2 diabetes. PN2034 restores responsiveness to insulin and enhances insulin action in the liver, according to Sanofi and its licensor, Wellstat Therapeutics. The molecule works through an undisclosed target distinct from that of best-selling insulin sensitizers already on the market, such as GlaxoSmithKline's Avandia (rosiglitazone) and Takeda's Actos (pioglitazone). “PN2034 has the potential to be used across the entire spectrum of [diabetes] patients,” Michael Bamat, Wellstat's vice president for research and development, said in an interview. Sanofi will pay an undisclosed up front fee to Wellstat. The total valueof the deal could reach as high as $350 million.

Saxagliptin Okayed in Europe

Bristol Myers-Squibb and AstraZeneca's dipeptidyl peptidase-4 inhibitor Onglyza (saxagliptin) is set to launch in Europe in early 2010 after being officially cleared for treatment of type 2 diabetes. A once-daily 5-mg dose of the oral drug was cleared by the European Commission as an add-on therapy with the common diabetes treatments metformin, sulfonylureas, and thiazolidinediones, the companies announced last month. An “add-on” indication in Europe contrasts with the wider label in the United States, where Onglyza can be used solo. The Food and Drug Administration approved the product in late July as an adjunct to diet and exercise for improving glycemic control in adults with type 2 diabetes.

Myriad Finds IND Candidate

Myriad Pharmaceuticals Inc. has identified an investigational drug candidate targeting a novel molecular target, the protein kinase IKK epsilon. Inhibitors of IKK epsilon are expected to have significant potential for the treatment of obesity, diabetes, and associated diseases. Myriad's IND candidate, MPI-0485520, is a selective and potent inhibitor of IKK epsilon, with both in vitro and in vivo biological activity. “MPI-0485520 represents a potentially very large commercial opportunity for Myriad Pharmaceuticals,” said Myriad president and CEO Adrian N. Hobden, Ph.D.

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

Study Examines Psychotropic Rx

Most antidepressants are prescribed by general practice physicians, including general practitioners, ob.gyns, and pediatricians, according to a study by sponsored by the Substance Abuse and Mental Health Services Administration. The study found that 62% of 232 million antidepressant prescriptions written between August 2006 and July 2007 were written by general practitioners, as were 59% of the 272 million prescriptions for psychotropic drugs. Pediatricians wrote 25% of all stimulant prescriptions. Psychiatrists and addiction specialists wrote two-thirds of the prescriptions for antimania medications, 49% of prescriptions for anti- psychotics, 34% of prescriptions for stimulants, and 21% of prescriptions for antipsychotics. The researchers noted that “concerns remain about whether patients treated in the general medical setting are receiving treatment concordant with evidence-based guidelines, psychotherapy, adequate medication monitoring, and appropriate intensity of treatment,” adding that a previous study found that about two-thirds of primary care physicians reported they were unable to obtain outpatient mental health services for patients. The study appears in the September issue of Psychiatric Services.

More HIPAA Goes to Rights Office

The Health and Human Services' Office for Civil Rights will now enforce the confidentiality of electronic health information as well as other patient records, HHS Secretary Kathleen Sebelius announced. The office already had responsibility for enforcing the HIPAA's privacy rule, which guards nonelectronic personal health information. But enforcement of the HIPAA security rule for electronic health information had been delegated to the Centers for Medicare and Medicaid Services. Legislation approved as part of the Recovery Act of 2009 mandated better enforcement of both rules. Ms. Sebelius noted in a statement that electronic and nonelectronic health information increasingly overlaps. “Combining the enforcement authority [for both rules] in one agency within HHS will facilitate improvements by eliminating duplication and increasing efficiency,” she said. CMS will continue to have authority for the administration and enforcement of other HIPAA regulations.

HHS Issues Privacy Breach Rules

The federal government is requiring physicians and other HIPAA covered entities to notify individuals when their protected health information has been breached. The rule went into effect last month. Under the rule, physicians have up to 60 calendar days from when they detect unauthorized access of protected health information to notify the patient. If the breach involves more than 500 individuals, the HHS secretary and a major media outlet in their area must be notified. “This new federal law ensures that covered entities and business associates are accountable to [HHS] and to individuals for proper safeguarding of the private information entrusted to their care,” said Robinsue Frohboese, acting director of the Office of Civil Rights at HHS. “These protections will be a cornerstone of maintaining consumer trust as we move forward with meaningful use of electronic health records and electronic exchange of health information.” There are exceptions: Notifications are not necessary if the information that was disclosed is unlikely to be retained. For example, if a nurse gives a patient the wrong discharge papers but quickly takes them back, it's reasonable to assume that the patient could not have retained that protected information, said HHS. More information is available at

www.hhs.gov/ocr/privacy

Lilly Payment Data Now Public

Eli Lilly & Co. has made good on its promise to publish how much it pays physicians and other health care professionals in consulting fees, honoraria, and the like. The drugmaker detailed the payments for the first quarter of 2009 at

www.lillyfacultyregistry.com

Youth Tobacco Sales Drop More

Sales of tobacco to children have reached historic lows, the Substance Abuse and Mental Health Services Administration said. SAMHSA credited the Synar Amendment program, which requires states to prohibit the sale and distribution of tobacco to people under age 18. All 50 states and the District of Columbia have, for the third year running, achieved better than 80% compliance among tobacco product retailers, said the agency. “Continued state vigilance will build on our track record of success in protecting children from the public health menace of tobacco,” said SAMHSA acting administrator Eric Broderick, D.D.S., in a statement.

Study Examines Psychotropic Rx

Most antidepressants are prescribed by general practice physicians, including general practitioners, ob.gyns, and pediatricians, according to a study by sponsored by the Substance Abuse and Mental Health Services Administration. The study found that 62% of 232 million antidepressant prescriptions written between August 2006 and July 2007 were written by general practitioners, as were 59% of the 272 million prescriptions for psychotropic drugs. Pediatricians wrote 25% of all stimulant prescriptions. Psychiatrists and addiction specialists wrote two-thirds of the prescriptions for antimania medications, 49% of prescriptions for anti- psychotics, 34% of prescriptions for stimulants, and 21% of prescriptions for antipsychotics. The researchers noted that “concerns remain about whether patients treated in the general medical setting are receiving treatment concordant with evidence-based guidelines, psychotherapy, adequate medication monitoring, and appropriate intensity of treatment,” adding that a previous study found that about two-thirds of primary care physicians reported they were unable to obtain outpatient mental health services for patients. The study appears in the September issue of Psychiatric Services.

More HIPAA Goes to Rights Office

The Health and Human Services' Office for Civil Rights will now enforce the confidentiality of electronic health information as well as other patient records, HHS Secretary Kathleen Sebelius announced. The office already had responsibility for enforcing the HIPAA's privacy rule, which guards nonelectronic personal health information. But enforcement of the HIPAA security rule for electronic health information had been delegated to the Centers for Medicare and Medicaid Services. Legislation approved as part of the Recovery Act of 2009 mandated better enforcement of both rules. Ms. Sebelius noted in a statement that electronic and nonelectronic health information increasingly overlaps. “Combining the enforcement authority [for both rules] in one agency within HHS will facilitate improvements by eliminating duplication and increasing efficiency,” she said. CMS will continue to have authority for the administration and enforcement of other HIPAA regulations.

HHS Issues Privacy Breach Rules

The federal government is requiring physicians and other HIPAA covered entities to notify individuals when their protected health information has been breached. The rule went into effect last month. Under the rule, physicians have up to 60 calendar days from when they detect unauthorized access of protected health information to notify the patient. If the breach involves more than 500 individuals, the HHS secretary and a major media outlet in their area must be notified. “This new federal law ensures that covered entities and business associates are accountable to [HHS] and to individuals for proper safeguarding of the private information entrusted to their care,” said Robinsue Frohboese, acting director of the Office of Civil Rights at HHS. “These protections will be a cornerstone of maintaining consumer trust as we move forward with meaningful use of electronic health records and electronic exchange of health information.” There are exceptions: Notifications are not necessary if the information that was disclosed is unlikely to be retained. For example, if a nurse gives a patient the wrong discharge papers but quickly takes them back, it's reasonable to assume that the patient could not have retained that protected information, said HHS. More information is available at

www.hhs.gov/ocr/privacy

Lilly Payment Data Now Public

Eli Lilly & Co. has made good on its promise to publish how much it pays physicians and other health care professionals in consulting fees, honoraria, and the like. The drugmaker detailed the payments for the first quarter of 2009 at

www.lillyfacultyregistry.com

Youth Tobacco Sales Drop More

Sales of tobacco to children have reached historic lows, the Substance Abuse and Mental Health Services Administration said. SAMHSA credited the Synar Amendment program, which requires states to prohibit the sale and distribution of tobacco to people under age 18. All 50 states and the District of Columbia have, for the third year running, achieved better than 80% compliance among tobacco product retailers, said the agency. “Continued state vigilance will build on our track record of success in protecting children from the public health menace of tobacco,” said SAMHSA acting administrator Eric Broderick, D.D.S., in a statement.

Study Examines Psychotropic Rx

Most antidepressants are prescribed by general practice physicians, including general practitioners, ob.gyns, and pediatricians, according to a study by sponsored by the Substance Abuse and Mental Health Services Administration. The study found that 62% of 232 million antidepressant prescriptions written between August 2006 and July 2007 were written by general practitioners, as were 59% of the 272 million prescriptions for psychotropic drugs. Pediatricians wrote 25% of all stimulant prescriptions. Psychiatrists and addiction specialists wrote two-thirds of the prescriptions for antimania medications, 49% of prescriptions for anti- psychotics, 34% of prescriptions for stimulants, and 21% of prescriptions for antipsychotics. The researchers noted that “concerns remain about whether patients treated in the general medical setting are receiving treatment concordant with evidence-based guidelines, psychotherapy, adequate medication monitoring, and appropriate intensity of treatment,” adding that a previous study found that about two-thirds of primary care physicians reported they were unable to obtain outpatient mental health services for patients. The study appears in the September issue of Psychiatric Services.

More HIPAA Goes to Rights Office

The Health and Human Services' Office for Civil Rights will now enforce the confidentiality of electronic health information as well as other patient records, HHS Secretary Kathleen Sebelius announced. The office already had responsibility for enforcing the HIPAA's privacy rule, which guards nonelectronic personal health information. But enforcement of the HIPAA security rule for electronic health information had been delegated to the Centers for Medicare and Medicaid Services. Legislation approved as part of the Recovery Act of 2009 mandated better enforcement of both rules. Ms. Sebelius noted in a statement that electronic and nonelectronic health information increasingly overlaps. “Combining the enforcement authority [for both rules] in one agency within HHS will facilitate improvements by eliminating duplication and increasing efficiency,” she said. CMS will continue to have authority for the administration and enforcement of other HIPAA regulations.

HHS Issues Privacy Breach Rules

The federal government is requiring physicians and other HIPAA covered entities to notify individuals when their protected health information has been breached. The rule went into effect last month. Under the rule, physicians have up to 60 calendar days from when they detect unauthorized access of protected health information to notify the patient. If the breach involves more than 500 individuals, the HHS secretary and a major media outlet in their area must be notified. “This new federal law ensures that covered entities and business associates are accountable to [HHS] and to individuals for proper safeguarding of the private information entrusted to their care,” said Robinsue Frohboese, acting director of the Office of Civil Rights at HHS. “These protections will be a cornerstone of maintaining consumer trust as we move forward with meaningful use of electronic health records and electronic exchange of health information.” There are exceptions: Notifications are not necessary if the information that was disclosed is unlikely to be retained. For example, if a nurse gives a patient the wrong discharge papers but quickly takes them back, it's reasonable to assume that the patient could not have retained that protected information, said HHS. More information is available at

www.hhs.gov/ocr/privacy

Lilly Payment Data Now Public

Eli Lilly & Co. has made good on its promise to publish how much it pays physicians and other health care professionals in consulting fees, honoraria, and the like. The drugmaker detailed the payments for the first quarter of 2009 at

www.lillyfacultyregistry.com

Youth Tobacco Sales Drop More

Sales of tobacco to children have reached historic lows, the Substance Abuse and Mental Health Services Administration said. SAMHSA credited the Synar Amendment program, which requires states to prohibit the sale and distribution of tobacco to people under age 18. All 50 states and the District of Columbia have, for the third year running, achieved better than 80% compliance among tobacco product retailers, said the agency. “Continued state vigilance will build on our track record of success in protecting children from the public health menace of tobacco,” said SAMHSA acting administrator Eric Broderick, D.D.S., in a statement.

Merck Licenses Depomed Patents

Depomed Inc. has provided a license to Merck & Co. for certain patents to develop fixed-dose combinations of sitagliptin and extended-release metformin for type 2 diabetes. Under the agreement, Merck will pay Depomed $10 million to receive a nonexclusive license and other rights to certain Depomed patents. Depomed is eligible to receive a milestone payment upon the filing of the New Drug Application for a drug that may be developed, and modest royalties on any net product sales for an agreed-upon period. Merck will be granted a “right of reference” in the NDA for Depomed's Glumetza (extended-release metformin hydrochloride tablets) in Merck's regulatory filings for a drug involving fixed-dose combinations of sitagliptin and extended-release metformin. Depomed has no development obligations under the agreement.

Patton, Unomedical in Partnership

Injection port therapy maker Patton Medical Devices LP has partnered with Unomedical, maker of single-use devices for diabetes patients, to develop the i-port Advance, a subcutaneous injection port that includes a disposable inserter. The device is designed to eliminate the need for manual insertion. “We believe the i-port Advance may help alleviate the potential for error from an improper manual insertion while providing the key benefit of having a simple way to deliver injections without the need to puncture the skin for each dose,” said John Burns, president of Patton. Patton has exclusive rights to market and distribute the i-port Advance in the United States and international markets, whereas Unomedical has exclusive manufacturing rights. The target date for commercial availability of the device is April 2010.

BioSante Raises $11 Million

BioSante Pharmaceuticals Inc., a Lincolnshire, Ill., biopharmaceutical firm, recently raised $11.1 million in a private placement a day after releasing positive phase III trial data for LibiGel, its transdermal testosterone gel. The company aims to be the first to reach the U.S. market with a female sexual dysfunction therapy, but is waiting for a cash-infusing merger with cancer biotechnology firm Cell Genesys Inc. to close. In an interview, BioSante CEO Stephen M. Simes predicted his company now will have sufficient cash to file a New Drug Application with the Food and Drug Administration for LibiGel during the first half of 2011. BioSante is open to out-licensing the compound during the remainder of the phase III program, he added, or waiting to find a commercialization partner following FDA approval.

SemBioSys Genetics Gets Patent

SemBioSys Genetics Inc. has been granted a U.S. patent, “Methods for the Production of Insulin in Plants.” The granted claims of the patent deal with a method for the commercial production of insulin in plant seeds. “Human insulin is currently the world's largest-volume protein pharmaceutical and is an ideal target for our oil-body-oleosin technology platform,” said James Szarko, president and CEO of SemBioSys, based in Calgary, Alta. “The issuance of this patent ensures our exclusivity to commercialize our insulin-production technology [in the United States] and offers competitive advantages to potential partners who wish to supply the expanding diabetes market,” he said. The company received a similar patent in Europe last year, and similar patents are pending in other countries, including Canada, Australia, Japan, China, India, and Mexico.

Debiopharm, Mercury Ink Pact

Debiopharm Group (Debiopharm), a group of biopharmaceutical companies based in Lausanne, Switzerland, and Mercury Therapeutics Inc., a biotech company in Woburn, Mass., have signed an exclusive license agreement for the development and commercialization of Debio 0930, a small molecule activator of adenosine monophosphate–activated protein kinase (AMPK) for the treatment of diabetes and metabolic diseases. Activation of AMPK has been shown to lower fasting blood glucose levels and improve glucose disposal following a glucose challenge. The agreement calls for Debiopharm to pay Mercury for continued research and development support, predefined advanced milestone payments during the development of the compound, and a royalty based on net sales of the commercialized product. The drug's first use in humans is expected to be in 2012.

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

Merck Licenses Depomed Patents

Depomed Inc. has provided a license to Merck & Co. for certain patents to develop fixed-dose combinations of sitagliptin and extended-release metformin for type 2 diabetes. Under the agreement, Merck will pay Depomed $10 million to receive a nonexclusive license and other rights to certain Depomed patents. Depomed is eligible to receive a milestone payment upon the filing of the New Drug Application for a drug that may be developed, and modest royalties on any net product sales for an agreed-upon period. Merck will be granted a “right of reference” in the NDA for Depomed's Glumetza (extended-release metformin hydrochloride tablets) in Merck's regulatory filings for a drug involving fixed-dose combinations of sitagliptin and extended-release metformin. Depomed has no development obligations under the agreement.

Patton, Unomedical in Partnership

Injection port therapy maker Patton Medical Devices LP has partnered with Unomedical, maker of single-use devices for diabetes patients, to develop the i-port Advance, a subcutaneous injection port that includes a disposable inserter. The device is designed to eliminate the need for manual insertion. “We believe the i-port Advance may help alleviate the potential for error from an improper manual insertion while providing the key benefit of having a simple way to deliver injections without the need to puncture the skin for each dose,” said John Burns, president of Patton. Patton has exclusive rights to market and distribute the i-port Advance in the United States and international markets, whereas Unomedical has exclusive manufacturing rights. The target date for commercial availability of the device is April 2010.

BioSante Raises $11 Million

BioSante Pharmaceuticals Inc., a Lincolnshire, Ill., biopharmaceutical firm, recently raised $11.1 million in a private placement a day after releasing positive phase III trial data for LibiGel, its transdermal testosterone gel. The company aims to be the first to reach the U.S. market with a female sexual dysfunction therapy, but is waiting for a cash-infusing merger with cancer biotechnology firm Cell Genesys Inc. to close. In an interview, BioSante CEO Stephen M. Simes predicted his company now will have sufficient cash to file a New Drug Application with the Food and Drug Administration for LibiGel during the first half of 2011. BioSante is open to out-licensing the compound during the remainder of the phase III program, he added, or waiting to find a commercialization partner following FDA approval.

SemBioSys Genetics Gets Patent

SemBioSys Genetics Inc. has been granted a U.S. patent, “Methods for the Production of Insulin in Plants.” The granted claims of the patent deal with a method for the commercial production of insulin in plant seeds. “Human insulin is currently the world's largest-volume protein pharmaceutical and is an ideal target for our oil-body-oleosin technology platform,” said James Szarko, president and CEO of SemBioSys, based in Calgary, Alta. “The issuance of this patent ensures our exclusivity to commercialize our insulin-production technology [in the United States] and offers competitive advantages to potential partners who wish to supply the expanding diabetes market,” he said. The company received a similar patent in Europe last year, and similar patents are pending in other countries, including Canada, Australia, Japan, China, India, and Mexico.

Debiopharm, Mercury Ink Pact

Debiopharm Group (Debiopharm), a group of biopharmaceutical companies based in Lausanne, Switzerland, and Mercury Therapeutics Inc., a biotech company in Woburn, Mass., have signed an exclusive license agreement for the development and commercialization of Debio 0930, a small molecule activator of adenosine monophosphate–activated protein kinase (AMPK) for the treatment of diabetes and metabolic diseases. Activation of AMPK has been shown to lower fasting blood glucose levels and improve glucose disposal following a glucose challenge. The agreement calls for Debiopharm to pay Mercury for continued research and development support, predefined advanced milestone payments during the development of the compound, and a royalty based on net sales of the commercialized product. The drug's first use in humans is expected to be in 2012.

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

Merck Licenses Depomed Patents

Depomed Inc. has provided a license to Merck & Co. for certain patents to develop fixed-dose combinations of sitagliptin and extended-release metformin for type 2 diabetes. Under the agreement, Merck will pay Depomed $10 million to receive a nonexclusive license and other rights to certain Depomed patents. Depomed is eligible to receive a milestone payment upon the filing of the New Drug Application for a drug that may be developed, and modest royalties on any net product sales for an agreed-upon period. Merck will be granted a “right of reference” in the NDA for Depomed's Glumetza (extended-release metformin hydrochloride tablets) in Merck's regulatory filings for a drug involving fixed-dose combinations of sitagliptin and extended-release metformin. Depomed has no development obligations under the agreement.

Patton, Unomedical in Partnership

Injection port therapy maker Patton Medical Devices LP has partnered with Unomedical, maker of single-use devices for diabetes patients, to develop the i-port Advance, a subcutaneous injection port that includes a disposable inserter. The device is designed to eliminate the need for manual insertion. “We believe the i-port Advance may help alleviate the potential for error from an improper manual insertion while providing the key benefit of having a simple way to deliver injections without the need to puncture the skin for each dose,” said John Burns, president of Patton. Patton has exclusive rights to market and distribute the i-port Advance in the United States and international markets, whereas Unomedical has exclusive manufacturing rights. The target date for commercial availability of the device is April 2010.

BioSante Raises $11 Million

BioSante Pharmaceuticals Inc., a Lincolnshire, Ill., biopharmaceutical firm, recently raised $11.1 million in a private placement a day after releasing positive phase III trial data for LibiGel, its transdermal testosterone gel. The company aims to be the first to reach the U.S. market with a female sexual dysfunction therapy, but is waiting for a cash-infusing merger with cancer biotechnology firm Cell Genesys Inc. to close. In an interview, BioSante CEO Stephen M. Simes predicted his company now will have sufficient cash to file a New Drug Application with the Food and Drug Administration for LibiGel during the first half of 2011. BioSante is open to out-licensing the compound during the remainder of the phase III program, he added, or waiting to find a commercialization partner following FDA approval.

SemBioSys Genetics Gets Patent

SemBioSys Genetics Inc. has been granted a U.S. patent, “Methods for the Production of Insulin in Plants.” The granted claims of the patent deal with a method for the commercial production of insulin in plant seeds. “Human insulin is currently the world's largest-volume protein pharmaceutical and is an ideal target for our oil-body-oleosin technology platform,” said James Szarko, president and CEO of SemBioSys, based in Calgary, Alta. “The issuance of this patent ensures our exclusivity to commercialize our insulin-production technology [in the United States] and offers competitive advantages to potential partners who wish to supply the expanding diabetes market,” he said. The company received a similar patent in Europe last year, and similar patents are pending in other countries, including Canada, Australia, Japan, China, India, and Mexico.

Debiopharm, Mercury Ink Pact

Debiopharm Group (Debiopharm), a group of biopharmaceutical companies based in Lausanne, Switzerland, and Mercury Therapeutics Inc., a biotech company in Woburn, Mass., have signed an exclusive license agreement for the development and commercialization of Debio 0930, a small molecule activator of adenosine monophosphate–activated protein kinase (AMPK) for the treatment of diabetes and metabolic diseases. Activation of AMPK has been shown to lower fasting blood glucose levels and improve glucose disposal following a glucose challenge. The agreement calls for Debiopharm to pay Mercury for continued research and development support, predefined advanced milestone payments during the development of the compound, and a royalty based on net sales of the commercialized product. The drug's first use in humans is expected to be in 2012.

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

Merck, Schering to Pay Fine

Merck and Schering-Plough will pay $5.4 million to 35 states and the District of Columbia to resolve an investigation into the firms' delayed release of negative study results for the cholesterol-lowering drug Vytorin (ezetimibe and simvastatin). The agreement, which is not an admission of liability, covers the states' and Washington's investigative costs. The ENHANCE trial found Vytorin was no more effective in reducing plaque in carotid arteries than was simvastatin alone.

Amgen, GSK to Join on Denosumab

Amgen and GlaxoSmithKline have agreed to share in the commercialization of Amgen's monoclonal antibody denosumab for postmenopausal osteoporosis in Europe, Australia, New Zealand, and Mexico. Amgen will commercialize denosumab—which has not yet been approved in these countries—for osteoporosis and oncology in the United States and Canada, and for all oncology indications in Europe and specified markets. GlaxoSmithKline will register and commercialize denosumab for all indications in countries where Amgen does not currently have a commercial presence, including China, Brazil, India, and South Korea. The arrangement includes an initial payment and near-term commercial milestones to Amgen totaling $120 million, and payment of ongoing royalties. “Our collaboration with GlaxoSmithKline will help Amgen bring the promise of denosumab to patients in Europe and other parts of the world more effectively than if we commercialized the drug globally on our own,” said Amgen CEO Kevin Sharer. Andrew Witty, CEO of GlaxoSmithKline, noted that “the data for denosumab [are] very encouraging and we believe it will provide significant benefit and value to patients with postmenopausal osteoporosis and other bone disease conditions.” Together with Amgen, we are committed to increasing worldwide access to this medicine.”

Allergan Lap Band OKed for Diabetes

Allergan's Lap-Band AP adjustable gastric banding system for obesity intervention has received European market approval for weight loss that leads to improvement or remission of type 2 diabetes, the firm has announced. The approval, the first of its kind, was supported by results of a 2-year randomized trial that confirmed results from previous observational studies. The study showed that patients who lost weight with Lap-Band AP were more than five times more likely to achieve remission of type 2 diabetes than were patients receiving conventional diabetes therapy (73% vs. 13%). Expanded labeling for the device states that weight loss associated with the system “has been shown to improve or lead to remission of type 2 diabetes,” the company said.

Sernova Gets Canadian Grant

An arm of the Canadian government, the National Research Council of Canada's Industrial Research Assistance Program, has awarded Sernova Corp. up to $486,000 to support a preclinical study of the company's Cell Pouch System for human cell transplantation. The Cell Pouch System will be used initially for treatment of insulin-dependent diabetes, and also has potential for use in other chronic diseases such as hemophilia, spinal cord injury, and Parkinson's disease. “We are grateful to NRC-IRAP for their crucial support of this important study, which will advance the development of a Canadian technology with ramifications for the treatment of insulin-dependent diabetics and other major diseases,” said Philip Toleikis, Ph.D., president and CEO of Sernova, based in London, Ont. “We appreciate NRC-IRAP's thorough review of our development program and look forward to commercializing our technology into multiple disease indications and major markets worldwide.” The study supported by NRC-IRAP involves implantation of Sernova's novel medical device into diabetic pigs to establish device parameters and optimize performance. The study is expected to begin this month and be completed within 12 months. The interim results from the first 3-6 months will be used to finalize the device design for the planned large animal study recommended by the Food and Drug Administration in support of a future phase I/II human clinical study. NRC-IRAP will reimburse Sernova for 100% of designated salary costs to a maximum of $262,000, and for 69% of contractor fees to a maximum of $224,000.

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

Merck, Schering to Pay Fine

Merck and Schering-Plough will pay $5.4 million to 35 states and the District of Columbia to resolve an investigation into the firms' delayed release of negative study results for the cholesterol-lowering drug Vytorin (ezetimibe and simvastatin). The agreement, which is not an admission of liability, covers the states' and Washington's investigative costs. The ENHANCE trial found Vytorin was no more effective in reducing plaque in carotid arteries than was simvastatin alone.

Amgen, GSK to Join on Denosumab

Amgen and GlaxoSmithKline have agreed to share in the commercialization of Amgen's monoclonal antibody denosumab for postmenopausal osteoporosis in Europe, Australia, New Zealand, and Mexico. Amgen will commercialize denosumab—which has not yet been approved in these countries—for osteoporosis and oncology in the United States and Canada, and for all oncology indications in Europe and specified markets. GlaxoSmithKline will register and commercialize denosumab for all indications in countries where Amgen does not currently have a commercial presence, including China, Brazil, India, and South Korea. The arrangement includes an initial payment and near-term commercial milestones to Amgen totaling $120 million, and payment of ongoing royalties. “Our collaboration with GlaxoSmithKline will help Amgen bring the promise of denosumab to patients in Europe and other parts of the world more effectively than if we commercialized the drug globally on our own,” said Amgen CEO Kevin Sharer. Andrew Witty, CEO of GlaxoSmithKline, noted that “the data for denosumab [are] very encouraging and we believe it will provide significant benefit and value to patients with postmenopausal osteoporosis and other bone disease conditions.” Together with Amgen, we are committed to increasing worldwide access to this medicine.”

Allergan Lap Band OKed for Diabetes

Allergan's Lap-Band AP adjustable gastric banding system for obesity intervention has received European market approval for weight loss that leads to improvement or remission of type 2 diabetes, the firm has announced. The approval, the first of its kind, was supported by results of a 2-year randomized trial that confirmed results from previous observational studies. The study showed that patients who lost weight with Lap-Band AP were more than five times more likely to achieve remission of type 2 diabetes than were patients receiving conventional diabetes therapy (73% vs. 13%). Expanded labeling for the device states that weight loss associated with the system “has been shown to improve or lead to remission of type 2 diabetes,” the company said.

Sernova Gets Canadian Grant

An arm of the Canadian government, the National Research Council of Canada's Industrial Research Assistance Program, has awarded Sernova Corp. up to $486,000 to support a preclinical study of the company's Cell Pouch System for human cell transplantation. The Cell Pouch System will be used initially for treatment of insulin-dependent diabetes, and also has potential for use in other chronic diseases such as hemophilia, spinal cord injury, and Parkinson's disease. “We are grateful to NRC-IRAP for their crucial support of this important study, which will advance the development of a Canadian technology with ramifications for the treatment of insulin-dependent diabetics and other major diseases,” said Philip Toleikis, Ph.D., president and CEO of Sernova, based in London, Ont. “We appreciate NRC-IRAP's thorough review of our development program and look forward to commercializing our technology into multiple disease indications and major markets worldwide.” The study supported by NRC-IRAP involves implantation of Sernova's novel medical device into diabetic pigs to establish device parameters and optimize performance. The study is expected to begin this month and be completed within 12 months. The interim results from the first 3-6 months will be used to finalize the device design for the planned large animal study recommended by the Food and Drug Administration in support of a future phase I/II human clinical study. NRC-IRAP will reimburse Sernova for 100% of designated salary costs to a maximum of $262,000, and for 69% of contractor fees to a maximum of $224,000.

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

Merck, Schering to Pay Fine

Merck and Schering-Plough will pay $5.4 million to 35 states and the District of Columbia to resolve an investigation into the firms' delayed release of negative study results for the cholesterol-lowering drug Vytorin (ezetimibe and simvastatin). The agreement, which is not an admission of liability, covers the states' and Washington's investigative costs. The ENHANCE trial found Vytorin was no more effective in reducing plaque in carotid arteries than was simvastatin alone.

Amgen, GSK to Join on Denosumab

Amgen and GlaxoSmithKline have agreed to share in the commercialization of Amgen's monoclonal antibody denosumab for postmenopausal osteoporosis in Europe, Australia, New Zealand, and Mexico. Amgen will commercialize denosumab—which has not yet been approved in these countries—for osteoporosis and oncology in the United States and Canada, and for all oncology indications in Europe and specified markets. GlaxoSmithKline will register and commercialize denosumab for all indications in countries where Amgen does not currently have a commercial presence, including China, Brazil, India, and South Korea. The arrangement includes an initial payment and near-term commercial milestones to Amgen totaling $120 million, and payment of ongoing royalties. “Our collaboration with GlaxoSmithKline will help Amgen bring the promise of denosumab to patients in Europe and other parts of the world more effectively than if we commercialized the drug globally on our own,” said Amgen CEO Kevin Sharer. Andrew Witty, CEO of GlaxoSmithKline, noted that “the data for denosumab [are] very encouraging and we believe it will provide significant benefit and value to patients with postmenopausal osteoporosis and other bone disease conditions.” Together with Amgen, we are committed to increasing worldwide access to this medicine.”

Allergan Lap Band OKed for Diabetes

Allergan's Lap-Band AP adjustable gastric banding system for obesity intervention has received European market approval for weight loss that leads to improvement or remission of type 2 diabetes, the firm has announced. The approval, the first of its kind, was supported by results of a 2-year randomized trial that confirmed results from previous observational studies. The study showed that patients who lost weight with Lap-Band AP were more than five times more likely to achieve remission of type 2 diabetes than were patients receiving conventional diabetes therapy (73% vs. 13%). Expanded labeling for the device states that weight loss associated with the system “has been shown to improve or lead to remission of type 2 diabetes,” the company said.

Sernova Gets Canadian Grant

An arm of the Canadian government, the National Research Council of Canada's Industrial Research Assistance Program, has awarded Sernova Corp. up to $486,000 to support a preclinical study of the company's Cell Pouch System for human cell transplantation. The Cell Pouch System will be used initially for treatment of insulin-dependent diabetes, and also has potential for use in other chronic diseases such as hemophilia, spinal cord injury, and Parkinson's disease. “We are grateful to NRC-IRAP for their crucial support of this important study, which will advance the development of a Canadian technology with ramifications for the treatment of insulin-dependent diabetics and other major diseases,” said Philip Toleikis, Ph.D., president and CEO of Sernova, based in London, Ont. “We appreciate NRC-IRAP's thorough review of our development program and look forward to commercializing our technology into multiple disease indications and major markets worldwide.” The study supported by NRC-IRAP involves implantation of Sernova's novel medical device into diabetic pigs to establish device parameters and optimize performance. The study is expected to begin this month and be completed within 12 months. The interim results from the first 3-6 months will be used to finalize the device design for the planned large animal study recommended by the Food and Drug Administration in support of a future phase I/II human clinical study. NRC-IRAP will reimburse Sernova for 100% of designated salary costs to a maximum of $262,000, and for 69% of contractor fees to a maximum of $224,000.

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

GE, Intel Form Alliance

GE and Intel Corporation are forming an alliance to develop products to help elderly patients manage their chronic illnesses, the companies announced. They will invest $250 million over the next 5 years for research and development of home health technologies in areas such as diabetes, cardiovascular disease, medication compliance, and sleep apnea. The market for telehealth and home health monitoring is predicted to grow from $3 billion in 2009 to an estimated $7.7 billion by 2012. GE Healthcare also will sell and market the Intel Health Guide, a personal health system that includes vital sign collection and communication tools, in the United States. “This partnership offers the potential to lower costs by keeping people out of hospitals while giving health professionals the data they need to deliver the best possible care,” Jeff Immelt, GE's board chairman and CEO, said in a statement.

Immuron Buys Hasadit's Technology

Immuron, a biopharmaceutical company, has agreed to acquire a novel oral immune modulation technology from Hadasit, the commercial arm of Hadassah Medical Center in Jerusalem. The combination of oral immune modulation with Immuron's existing oral protein and antibody technology could yield “a convenient, all-natural, side effect-free approach to address serious diseases which have multibillion-dollar markets, including metabolic syndrome, hepatitis C, and type 2 diabetes,” the company said in a statement. Immuron will focus its initial clinical development effort with this platform technology on metabolic syndrome, chronic hepatitis C, and liver cancer. Hadasit also will provide discounted clinical and laboratory services to Immuron. In return, Hadasit shall be issued 19.99% of Immuron's equity at the time of the approval of the transaction by Immuron's shareholders, as well as royalties on certain Immuron products. Professor Yaron Ilan of Hadassah Medical Center will become the medical director of Immuron.

Quest Pays Government $302 Million

Quest Diagnostics will pay the government $302 million to settle False Claim Act allegations that a former subsidiary knowingly sold a parathyroid hormone test kit with inaccurate performance claims, the Justice Department reported. The investigation was initiated by a whistleblower lawsuit filed by a Quest competitor in 2004. The payout is one of the largest recoveries in a case involving a medical device, according to the Justice Department. “This settlement provides further evidence that the department will vigorously prosecute cases involving violations of the Food, Drug, and Cosmetic Act, and will pursue recovery of taxpayer dollars resulting from fraudulent marketing campaigns by medical device manufacturers,” said Michael F. Hertz, acting assistant attorney general for the civil division.

Novocell Receives Endoderm Patent

Novocell Inc., a stem cell engineering company, has received a patent for its work with human definitive endoderm cells, an essential cell for generating pancreatic-type cells and other endoderm lineage-derived tissues and organs, including lung, intestine, liver, thymus, and thyroid cells. Novocell is developing pancreatic-type cells for use in diabetes therapy. “This composition patent is a milestone achievement for Novocell and is the culmination of extensive research that opened the door to the endoderm lineage,” said Fred Middleton, Novocell's chairman and acting CEO. “The efficient production of endoderm represents the first critical step in the creation of a renewable islet source derived from [human embryonic stem] cells that is targeted at restoring normal glucose regulation in diabetic patients.”

Biodel Plans VIAject NDA

Biodel Inc. plans to submit a new drug application to the Food and Drug Administration for approval to market its VIAject ultrarapid-acting injectable human insulin for the treatment of diabetes, the company announced last month. VIAject is intended for mealtime use by type 1 or type 2 diabetes patients. The NDA will be based upon results from multiple pharmacokinetic and pharmacodynamic studies as well as two completed phase III studies. Now that the company has cleared up some issues surrounding patient data from India, “We are … comfortable proceeding with the preparation and submission of the NDA for VIAject in the second half of this year,” said Solomon Steiner, Ph.D., Biodel's chairman and CEO. “This is based on a compelling package of pharmacodynamic studies demonstrating potential advantages over currently available rapid-acting insulin analogs as well as the results of both pivotal phase III clinical trials, which we believe met the end point of noninferior change in HbA1c over 6 months.”

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

GE, Intel Form Alliance

GE and Intel Corporation are forming an alliance to develop products to help elderly patients manage their chronic illnesses, the companies announced. They will invest $250 million over the next 5 years for research and development of home health technologies in areas such as diabetes, cardiovascular disease, medication compliance, and sleep apnea. The market for telehealth and home health monitoring is predicted to grow from $3 billion in 2009 to an estimated $7.7 billion by 2012. GE Healthcare also will sell and market the Intel Health Guide, a personal health system that includes vital sign collection and communication tools, in the United States. “This partnership offers the potential to lower costs by keeping people out of hospitals while giving health professionals the data they need to deliver the best possible care,” Jeff Immelt, GE's board chairman and CEO, said in a statement.

Immuron Buys Hasadit's Technology

Immuron, a biopharmaceutical company, has agreed to acquire a novel oral immune modulation technology from Hadasit, the commercial arm of Hadassah Medical Center in Jerusalem. The combination of oral immune modulation with Immuron's existing oral protein and antibody technology could yield “a convenient, all-natural, side effect-free approach to address serious diseases which have multibillion-dollar markets, including metabolic syndrome, hepatitis C, and type 2 diabetes,” the company said in a statement. Immuron will focus its initial clinical development effort with this platform technology on metabolic syndrome, chronic hepatitis C, and liver cancer. Hadasit also will provide discounted clinical and laboratory services to Immuron. In return, Hadasit shall be issued 19.99% of Immuron's equity at the time of the approval of the transaction by Immuron's shareholders, as well as royalties on certain Immuron products. Professor Yaron Ilan of Hadassah Medical Center will become the medical director of Immuron.

Quest Pays Government $302 Million

Quest Diagnostics will pay the government $302 million to settle False Claim Act allegations that a former subsidiary knowingly sold a parathyroid hormone test kit with inaccurate performance claims, the Justice Department reported. The investigation was initiated by a whistleblower lawsuit filed by a Quest competitor in 2004. The payout is one of the largest recoveries in a case involving a medical device, according to the Justice Department. “This settlement provides further evidence that the department will vigorously prosecute cases involving violations of the Food, Drug, and Cosmetic Act, and will pursue recovery of taxpayer dollars resulting from fraudulent marketing campaigns by medical device manufacturers,” said Michael F. Hertz, acting assistant attorney general for the civil division.

Novocell Receives Endoderm Patent

Novocell Inc., a stem cell engineering company, has received a patent for its work with human definitive endoderm cells, an essential cell for generating pancreatic-type cells and other endoderm lineage-derived tissues and organs, including lung, intestine, liver, thymus, and thyroid cells. Novocell is developing pancreatic-type cells for use in diabetes therapy. “This composition patent is a milestone achievement for Novocell and is the culmination of extensive research that opened the door to the endoderm lineage,” said Fred Middleton, Novocell's chairman and acting CEO. “The efficient production of endoderm represents the first critical step in the creation of a renewable islet source derived from [human embryonic stem] cells that is targeted at restoring normal glucose regulation in diabetic patients.”

Biodel Plans VIAject NDA

Biodel Inc. plans to submit a new drug application to the Food and Drug Administration for approval to market its VIAject ultrarapid-acting injectable human insulin for the treatment of diabetes, the company announced last month. VIAject is intended for mealtime use by type 1 or type 2 diabetes patients. The NDA will be based upon results from multiple pharmacokinetic and pharmacodynamic studies as well as two completed phase III studies. Now that the company has cleared up some issues surrounding patient data from India, “We are … comfortable proceeding with the preparation and submission of the NDA for VIAject in the second half of this year,” said Solomon Steiner, Ph.D., Biodel's chairman and CEO. “This is based on a compelling package of pharmacodynamic studies demonstrating potential advantages over currently available rapid-acting insulin analogs as well as the results of both pivotal phase III clinical trials, which we believe met the end point of noninferior change in HbA1c over 6 months.”

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

GE, Intel Form Alliance

GE and Intel Corporation are forming an alliance to develop products to help elderly patients manage their chronic illnesses, the companies announced. They will invest $250 million over the next 5 years for research and development of home health technologies in areas such as diabetes, cardiovascular disease, medication compliance, and sleep apnea. The market for telehealth and home health monitoring is predicted to grow from $3 billion in 2009 to an estimated $7.7 billion by 2012. GE Healthcare also will sell and market the Intel Health Guide, a personal health system that includes vital sign collection and communication tools, in the United States. “This partnership offers the potential to lower costs by keeping people out of hospitals while giving health professionals the data they need to deliver the best possible care,” Jeff Immelt, GE's board chairman and CEO, said in a statement.

Immuron Buys Hasadit's Technology

Immuron, a biopharmaceutical company, has agreed to acquire a novel oral immune modulation technology from Hadasit, the commercial arm of Hadassah Medical Center in Jerusalem. The combination of oral immune modulation with Immuron's existing oral protein and antibody technology could yield “a convenient, all-natural, side effect-free approach to address serious diseases which have multibillion-dollar markets, including metabolic syndrome, hepatitis C, and type 2 diabetes,” the company said in a statement. Immuron will focus its initial clinical development effort with this platform technology on metabolic syndrome, chronic hepatitis C, and liver cancer. Hadasit also will provide discounted clinical and laboratory services to Immuron. In return, Hadasit shall be issued 19.99% of Immuron's equity at the time of the approval of the transaction by Immuron's shareholders, as well as royalties on certain Immuron products. Professor Yaron Ilan of Hadassah Medical Center will become the medical director of Immuron.

Quest Pays Government $302 Million

Quest Diagnostics will pay the government $302 million to settle False Claim Act allegations that a former subsidiary knowingly sold a parathyroid hormone test kit with inaccurate performance claims, the Justice Department reported. The investigation was initiated by a whistleblower lawsuit filed by a Quest competitor in 2004. The payout is one of the largest recoveries in a case involving a medical device, according to the Justice Department. “This settlement provides further evidence that the department will vigorously prosecute cases involving violations of the Food, Drug, and Cosmetic Act, and will pursue recovery of taxpayer dollars resulting from fraudulent marketing campaigns by medical device manufacturers,” said Michael F. Hertz, acting assistant attorney general for the civil division.

Novocell Receives Endoderm Patent

Novocell Inc., a stem cell engineering company, has received a patent for its work with human definitive endoderm cells, an essential cell for generating pancreatic-type cells and other endoderm lineage-derived tissues and organs, including lung, intestine, liver, thymus, and thyroid cells. Novocell is developing pancreatic-type cells for use in diabetes therapy. “This composition patent is a milestone achievement for Novocell and is the culmination of extensive research that opened the door to the endoderm lineage,” said Fred Middleton, Novocell's chairman and acting CEO. “The efficient production of endoderm represents the first critical step in the creation of a renewable islet source derived from [human embryonic stem] cells that is targeted at restoring normal glucose regulation in diabetic patients.”

Biodel Plans VIAject NDA

Biodel Inc. plans to submit a new drug application to the Food and Drug Administration for approval to market its VIAject ultrarapid-acting injectable human insulin for the treatment of diabetes, the company announced last month. VIAject is intended for mealtime use by type 1 or type 2 diabetes patients. The NDA will be based upon results from multiple pharmacokinetic and pharmacodynamic studies as well as two completed phase III studies. Now that the company has cleared up some issues surrounding patient data from India, “We are … comfortable proceeding with the preparation and submission of the NDA for VIAject in the second half of this year,” said Solomon Steiner, Ph.D., Biodel's chairman and CEO. “This is based on a compelling package of pharmacodynamic studies demonstrating potential advantages over currently available rapid-acting insulin analogs as well as the results of both pivotal phase III clinical trials, which we believe met the end point of noninferior change in HbA1c over 6 months.”

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

Even as the rate of new 2009-H1N1 infections dwindles in the Northern Hemisphere, infection officials are bracing for the influenza's potential re-emergence this fall.

At press time, the House Appropriations Committee had approved $2.05 billion in emergency supplemental funding to increase surveillance of outbreaks and to purchase antivirals and antibiotics to help stop the spread of the infection. This amount was $550 million more than President Obams had requested.

Efforts are underway to develop a vaccine for 2009-H1N1. “We're taking those initial steps that are important and necessary should a vaccine [for 2009-H1N1] need to be made,” said Dr. Richard E. Besser, acting director of the U.S. Centers for Disease Control and Prevention. “There are a lot of decisions that need to be made between now and” this fall, when people start receiving their flu shots.

Current gaps in knowledge about 2009-H1N1 are expected to be filled in the coming months as the flu season unfolds in the Southern Hemisphere. During this time, he said, epidemiologists will be seeking answers to several questions: How does the virus compete with other viruses that are circulating in the community? Does it change, and if so, in what way? Does it develop resistance?

If given the go-ahead, the bulk of vaccine production can start at the end of June, which means that the earliest a 2009-H1N1 vaccine will be available is in September, according to Klaus Stöhr, D.V.M., vice president and global head of Novartis Vaccines and Diagnostics Ltd. and former head of the World Health Organization's Global Influenza Program. Dr. Stöhr spoke at the international conference on Influenza Vaccines for the World held in Cannes, France.

The number of inoculations necessary will depend on how potent the vaccine needs to be, explained Dr. William Schaffner, chair of the department of preventive medicine at Vanderbilt University, Nashville, Tenn. In all likelihood, the 2009-H1N1 vaccine will require two shots to ensure immunity.

Couple that with the logistics of providing the seasonal influenza vaccine and “the potential for confusion is vast,” he said in an interview.

Because people get immunized against the flu in so many different settings, it will be difficult to keep track of which shots an individual has actually received. It may help to make the 2009-H1N1 vaccine available only at public health clinics, but they are not staffed or organized to immunize a large portion of the population. It will also be quite difficult to track side effects specifically from the 2009-H1N1 vaccine.

The good news is that “what we're seeing so far is a fair amount of stability in the virus,” Dr. Besser said.

At press time, virus isolates from the United States, Canada, Germany, Mexico, the Netherlands, and New Zealand had been genetically sequenced and “all of the genes examined were 99%-100% identical. This means it will be somewhat easier to produce an influenza vaccine,” said Nancy Cox, Ph.D., chief of the influenza division at the CDC.

A lot could happen, however, between now and the fall. “We could see the current strain fizzle out and never come back again. We could see the current strain come back as it currently is, or we could see it mutate and come back in a more severe form. What we need to do during this period is make sure that we're prepared as a government, as a public health agency, [and] that our laboratories are ready should this come back as a much more severe infection,” Dr. Besser said at a CDC press briefing.

So far, the genetic analysis of 2009-H1N1 has shown no sign of the virulence markers found in the 1918 pandemic influenza strain, also an H1N1 type, Dr. Cox said at CDC press briefing.

The 2009-H1N1 strain is “easily transmitted,” with an attack rate of about 25%-30%, based on early analyses of person-to-person spread within families and households, said Dr. Anne Schuchat, the CDC's interim deputy director for science and public health programs. This attack rate is comparable to what is usually seen among most seasonal influenza strains.

Even as the rate of new 2009-H1N1 infections dwindles in the Northern Hemisphere, infection officials are bracing for the influenza's potential re-emergence this fall.

At press time, the House Appropriations Committee had approved $2.05 billion in emergency supplemental funding to increase surveillance of outbreaks and to purchase antivirals and antibiotics to help stop the spread of the infection. This amount was $550 million more than President Obams had requested.

Efforts are underway to develop a vaccine for 2009-H1N1. “We're taking those initial steps that are important and necessary should a vaccine [for 2009-H1N1] need to be made,” said Dr. Richard E. Besser, acting director of the U.S. Centers for Disease Control and Prevention. “There are a lot of decisions that need to be made between now and” this fall, when people start receiving their flu shots.

Current gaps in knowledge about 2009-H1N1 are expected to be filled in the coming months as the flu season unfolds in the Southern Hemisphere. During this time, he said, epidemiologists will be seeking answers to several questions: How does the virus compete with other viruses that are circulating in the community? Does it change, and if so, in what way? Does it develop resistance?

If given the go-ahead, the bulk of vaccine production can start at the end of June, which means that the earliest a 2009-H1N1 vaccine will be available is in September, according to Klaus Stöhr, D.V.M., vice president and global head of Novartis Vaccines and Diagnostics Ltd. and former head of the World Health Organization's Global Influenza Program. Dr. Stöhr spoke at the international conference on Influenza Vaccines for the World held in Cannes, France.

The number of inoculations necessary will depend on how potent the vaccine needs to be, explained Dr. William Schaffner, chair of the department of preventive medicine at Vanderbilt University, Nashville, Tenn. In all likelihood, the 2009-H1N1 vaccine will require two shots to ensure immunity.

Couple that with the logistics of providing the seasonal influenza vaccine and “the potential for confusion is vast,” he said in an interview.

Because people get immunized against the flu in so many different settings, it will be difficult to keep track of which shots an individual has actually received. It may help to make the 2009-H1N1 vaccine available only at public health clinics, but they are not staffed or organized to immunize a large portion of the population. It will also be quite difficult to track side effects specifically from the 2009-H1N1 vaccine.

The good news is that “what we're seeing so far is a fair amount of stability in the virus,” Dr. Besser said.

At press time, virus isolates from the United States, Canada, Germany, Mexico, the Netherlands, and New Zealand had been genetically sequenced and “all of the genes examined were 99%-100% identical. This means it will be somewhat easier to produce an influenza vaccine,” said Nancy Cox, Ph.D., chief of the influenza division at the CDC.

A lot could happen, however, between now and the fall. “We could see the current strain fizzle out and never come back again. We could see the current strain come back as it currently is, or we could see it mutate and come back in a more severe form. What we need to do during this period is make sure that we're prepared as a government, as a public health agency, [and] that our laboratories are ready should this come back as a much more severe infection,” Dr. Besser said at a CDC press briefing.

So far, the genetic analysis of 2009-H1N1 has shown no sign of the virulence markers found in the 1918 pandemic influenza strain, also an H1N1 type, Dr. Cox said at CDC press briefing.

The 2009-H1N1 strain is “easily transmitted,” with an attack rate of about 25%-30%, based on early analyses of person-to-person spread within families and households, said Dr. Anne Schuchat, the CDC's interim deputy director for science and public health programs. This attack rate is comparable to what is usually seen among most seasonal influenza strains.

Even as the rate of new 2009-H1N1 infections dwindles in the Northern Hemisphere, infection officials are bracing for the influenza's potential re-emergence this fall.

At press time, the House Appropriations Committee had approved $2.05 billion in emergency supplemental funding to increase surveillance of outbreaks and to purchase antivirals and antibiotics to help stop the spread of the infection. This amount was $550 million more than President Obams had requested.

Efforts are underway to develop a vaccine for 2009-H1N1. “We're taking those initial steps that are important and necessary should a vaccine [for 2009-H1N1] need to be made,” said Dr. Richard E. Besser, acting director of the U.S. Centers for Disease Control and Prevention. “There are a lot of decisions that need to be made between now and” this fall, when people start receiving their flu shots.

Current gaps in knowledge about 2009-H1N1 are expected to be filled in the coming months as the flu season unfolds in the Southern Hemisphere. During this time, he said, epidemiologists will be seeking answers to several questions: How does the virus compete with other viruses that are circulating in the community? Does it change, and if so, in what way? Does it develop resistance?

If given the go-ahead, the bulk of vaccine production can start at the end of June, which means that the earliest a 2009-H1N1 vaccine will be available is in September, according to Klaus Stöhr, D.V.M., vice president and global head of Novartis Vaccines and Diagnostics Ltd. and former head of the World Health Organization's Global Influenza Program. Dr. Stöhr spoke at the international conference on Influenza Vaccines for the World held in Cannes, France.

The number of inoculations necessary will depend on how potent the vaccine needs to be, explained Dr. William Schaffner, chair of the department of preventive medicine at Vanderbilt University, Nashville, Tenn. In all likelihood, the 2009-H1N1 vaccine will require two shots to ensure immunity.

Couple that with the logistics of providing the seasonal influenza vaccine and “the potential for confusion is vast,” he said in an interview.

Because people get immunized against the flu in so many different settings, it will be difficult to keep track of which shots an individual has actually received. It may help to make the 2009-H1N1 vaccine available only at public health clinics, but they are not staffed or organized to immunize a large portion of the population. It will also be quite difficult to track side effects specifically from the 2009-H1N1 vaccine.

The good news is that “what we're seeing so far is a fair amount of stability in the virus,” Dr. Besser said.

At press time, virus isolates from the United States, Canada, Germany, Mexico, the Netherlands, and New Zealand had been genetically sequenced and “all of the genes examined were 99%-100% identical. This means it will be somewhat easier to produce an influenza vaccine,” said Nancy Cox, Ph.D., chief of the influenza division at the CDC.

A lot could happen, however, between now and the fall. “We could see the current strain fizzle out and never come back again. We could see the current strain come back as it currently is, or we could see it mutate and come back in a more severe form. What we need to do during this period is make sure that we're prepared as a government, as a public health agency, [and] that our laboratories are ready should this come back as a much more severe infection,” Dr. Besser said at a CDC press briefing.

So far, the genetic analysis of 2009-H1N1 has shown no sign of the virulence markers found in the 1918 pandemic influenza strain, also an H1N1 type, Dr. Cox said at CDC press briefing.

The 2009-H1N1 strain is “easily transmitted,” with an attack rate of about 25%-30%, based on early analyses of person-to-person spread within families and households, said Dr. Anne Schuchat, the CDC's interim deputy director for science and public health programs. This attack rate is comparable to what is usually seen among most seasonal influenza strains.

NeuroMetrix Settles Charges

NeuroMetrix will pay $3.7 million to the government and will comply with a 5-year corporate integrity agreement to settle allegations that it provided illegal kickbacks to physicians as part of a marketing program for its NC-stat neuropathy diagnostic system. The settlement, announced last month, relates to marketing practices during August 2004-2006, and fraudulent reimbursement practices during January 2003-April 2006, according to the Department of Justice. The deal stems from an investigation that began in 2006 and resolves allegations that the firm paid illegal kickbacks to physicians to encourage them to use NC-stat, and in certain circumstances led them to improperly bill Medicare.

DiaMedica Names New CEO

DiaMedica Inc., a drug discovery and clinical development company based in Winnipeg, Canada, that focuses on novel treatments for type 2 diabetes, has named Reginald (Reggie) Bowerman as its president and chief executive officer, the company announced last month. Mr. Bowerman has worked in the pharmaceutical industry for 23 years, most recently as vice president of commercial operations at MGI Pharma. He will be based in Minneapolis. “We are excited that Mr. Bowerman is joining DiaMedica in a senior leadership capacity,” said Rick Pauls, immediate past president and CEO of DiaMedica. “Mr. Bowerman's long track record of commercial success, exceptional leadership, interpersonal and organizational skills, along with a diverse industry background in the pharmaceutical sector, will guide DiaMedica as we continue to develop into a world-class biopharmaceutical company. The widely recognized success of MGI Pharma as a biopharmaceutical company, in which Mr. Bowerman played a key leadership role, will provide him with significant insights into where we seek to move DiaMedica going forward,” said Mr. Pauls, who will continue to serve as chairman of DiaMedica's board of directors and will work closely with Mr. Bowerman during the transition. In accordance with the company's stock option plan, DiaMedica has granted Mr. Bowerman 500,000 stock options at an exercise price of $1.00 per share. The options are subject to regulatory approval.

Ceapro, IR2Dx Sign Agreement

Ceapro Inc. has signed a research and commercial development agreement with IR2Dx Inc., an assay development firm, to conduct a research project comparing the commonly used liquid oral glucose tolerance test to CeaProve, a test food developed by Ceapro. CeaProve comprises six wafers containing 50 g of glycemic carbohydrate, fat, and protein. The standard glucose tolerance test “is widely perceived to have significant weaknesses and limitations, including variability, false negatives, required time of over 2 hours, and side effects, which are addressed or minimized with CeaProve,” the company said in a statement last month announcing the agreement. After the completion of a pilot phase, the company expects that 500 patients will be enrolled in a multisite trial, expected to last about a year. CeaProve's development costs will be jointly covered by Ceapro and IR2Dx. Ceapro will remain responsible for the manufacturing of the product and will receive royalties on net sales in addition to regulatory milestones. IR2Dx will have worldwide marketing rights for thehospital, clinic, and physician market.

HGS Receives Milestone Payment

The pharmaceutical company Human Genome Sciences announced last month that GlaxoSmithKline has begun a phase III clinical trial program to evaluate the efficacy, safety, and tolerability of albiglutide (Syncria) in the long-term treatment of type 2 diabetes. As a result, HGS will receive a $9-million milestone payment in the first quarter of this year. “We are delighted that GSK has advanced Syncria to phase III development, and we look forward to the future progress of this important program,” H. Thomas Watkins, Human Genome Sciences' president and CEO, said in a statement. Syncria is made from the genetic fusion of human albumin and modified human GLP-1 peptide, and is designed to act throughout the body to help maintain normal blood sugar levels and control appetite. HGS, which licensed Syncria to GSK in 2004, is entitled to fees and milestone payments of up to $183 million—including $24 million received so far—if Syncria is commercialized.

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

NeuroMetrix Settles Charges

NeuroMetrix will pay $3.7 million to the government and will comply with a 5-year corporate integrity agreement to settle allegations that it provided illegal kickbacks to physicians as part of a marketing program for its NC-stat neuropathy diagnostic system. The settlement, announced last month, relates to marketing practices during August 2004-2006, and fraudulent reimbursement practices during January 2003-April 2006, according to the Department of Justice. The deal stems from an investigation that began in 2006 and resolves allegations that the firm paid illegal kickbacks to physicians to encourage them to use NC-stat, and in certain circumstances led them to improperly bill Medicare.

DiaMedica Names New CEO

DiaMedica Inc., a drug discovery and clinical development company based in Winnipeg, Canada, that focuses on novel treatments for type 2 diabetes, has named Reginald (Reggie) Bowerman as its president and chief executive officer, the company announced last month. Mr. Bowerman has worked in the pharmaceutical industry for 23 years, most recently as vice president of commercial operations at MGI Pharma. He will be based in Minneapolis. “We are excited that Mr. Bowerman is joining DiaMedica in a senior leadership capacity,” said Rick Pauls, immediate past president and CEO of DiaMedica. “Mr. Bowerman's long track record of commercial success, exceptional leadership, interpersonal and organizational skills, along with a diverse industry background in the pharmaceutical sector, will guide DiaMedica as we continue to develop into a world-class biopharmaceutical company. The widely recognized success of MGI Pharma as a biopharmaceutical company, in which Mr. Bowerman played a key leadership role, will provide him with significant insights into where we seek to move DiaMedica going forward,” said Mr. Pauls, who will continue to serve as chairman of DiaMedica's board of directors and will work closely with Mr. Bowerman during the transition. In accordance with the company's stock option plan, DiaMedica has granted Mr. Bowerman 500,000 stock options at an exercise price of $1.00 per share. The options are subject to regulatory approval.

Ceapro, IR2Dx Sign Agreement

Ceapro Inc. has signed a research and commercial development agreement with IR2Dx Inc., an assay development firm, to conduct a research project comparing the commonly used liquid oral glucose tolerance test to CeaProve, a test food developed by Ceapro. CeaProve comprises six wafers containing 50 g of glycemic carbohydrate, fat, and protein. The standard glucose tolerance test “is widely perceived to have significant weaknesses and limitations, including variability, false negatives, required time of over 2 hours, and side effects, which are addressed or minimized with CeaProve,” the company said in a statement last month announcing the agreement. After the completion of a pilot phase, the company expects that 500 patients will be enrolled in a multisite trial, expected to last about a year. CeaProve's development costs will be jointly covered by Ceapro and IR2Dx. Ceapro will remain responsible for the manufacturing of the product and will receive royalties on net sales in addition to regulatory milestones. IR2Dx will have worldwide marketing rights for thehospital, clinic, and physician market.

HGS Receives Milestone Payment

The pharmaceutical company Human Genome Sciences announced last month that GlaxoSmithKline has begun a phase III clinical trial program to evaluate the efficacy, safety, and tolerability of albiglutide (Syncria) in the long-term treatment of type 2 diabetes. As a result, HGS will receive a $9-million milestone payment in the first quarter of this year. “We are delighted that GSK has advanced Syncria to phase III development, and we look forward to the future progress of this important program,” H. Thomas Watkins, Human Genome Sciences' president and CEO, said in a statement. Syncria is made from the genetic fusion of human albumin and modified human GLP-1 peptide, and is designed to act throughout the body to help maintain normal blood sugar levels and control appetite. HGS, which licensed Syncria to GSK in 2004, is entitled to fees and milestone payments of up to $183 million—including $24 million received so far—if Syncria is commercialized.

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

NeuroMetrix Settles Charges

NeuroMetrix will pay $3.7 million to the government and will comply with a 5-year corporate integrity agreement to settle allegations that it provided illegal kickbacks to physicians as part of a marketing program for its NC-stat neuropathy diagnostic system. The settlement, announced last month, relates to marketing practices during August 2004-2006, and fraudulent reimbursement practices during January 2003-April 2006, according to the Department of Justice. The deal stems from an investigation that began in 2006 and resolves allegations that the firm paid illegal kickbacks to physicians to encourage them to use NC-stat, and in certain circumstances led them to improperly bill Medicare.

DiaMedica Names New CEO

DiaMedica Inc., a drug discovery and clinical development company based in Winnipeg, Canada, that focuses on novel treatments for type 2 diabetes, has named Reginald (Reggie) Bowerman as its president and chief executive officer, the company announced last month. Mr. Bowerman has worked in the pharmaceutical industry for 23 years, most recently as vice president of commercial operations at MGI Pharma. He will be based in Minneapolis. “We are excited that Mr. Bowerman is joining DiaMedica in a senior leadership capacity,” said Rick Pauls, immediate past president and CEO of DiaMedica. “Mr. Bowerman's long track record of commercial success, exceptional leadership, interpersonal and organizational skills, along with a diverse industry background in the pharmaceutical sector, will guide DiaMedica as we continue to develop into a world-class biopharmaceutical company. The widely recognized success of MGI Pharma as a biopharmaceutical company, in which Mr. Bowerman played a key leadership role, will provide him with significant insights into where we seek to move DiaMedica going forward,” said Mr. Pauls, who will continue to serve as chairman of DiaMedica's board of directors and will work closely with Mr. Bowerman during the transition. In accordance with the company's stock option plan, DiaMedica has granted Mr. Bowerman 500,000 stock options at an exercise price of $1.00 per share. The options are subject to regulatory approval.

Ceapro, IR2Dx Sign Agreement

Ceapro Inc. has signed a research and commercial development agreement with IR2Dx Inc., an assay development firm, to conduct a research project comparing the commonly used liquid oral glucose tolerance test to CeaProve, a test food developed by Ceapro. CeaProve comprises six wafers containing 50 g of glycemic carbohydrate, fat, and protein. The standard glucose tolerance test “is widely perceived to have significant weaknesses and limitations, including variability, false negatives, required time of over 2 hours, and side effects, which are addressed or minimized with CeaProve,” the company said in a statement last month announcing the agreement. After the completion of a pilot phase, the company expects that 500 patients will be enrolled in a multisite trial, expected to last about a year. CeaProve's development costs will be jointly covered by Ceapro and IR2Dx. Ceapro will remain responsible for the manufacturing of the product and will receive royalties on net sales in addition to regulatory milestones. IR2Dx will have worldwide marketing rights for thehospital, clinic, and physician market.

HGS Receives Milestone Payment

The pharmaceutical company Human Genome Sciences announced last month that GlaxoSmithKline has begun a phase III clinical trial program to evaluate the efficacy, safety, and tolerability of albiglutide (Syncria) in the long-term treatment of type 2 diabetes. As a result, HGS will receive a $9-million milestone payment in the first quarter of this year. “We are delighted that GSK has advanced Syncria to phase III development, and we look forward to the future progress of this important program,” H. Thomas Watkins, Human Genome Sciences' president and CEO, said in a statement. Syncria is made from the genetic fusion of human albumin and modified human GLP-1 peptide, and is designed to act throughout the body to help maintain normal blood sugar levels and control appetite. HGS, which licensed Syncria to GSK in 2004, is entitled to fees and milestone payments of up to $183 million—including $24 million received so far—if Syncria is commercialized.

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