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CLX to Buy ThyroTest
CLX Medical has entered into a letter of intent with ThyroTec, LLC, to acquire ThyroTest, a rapid thyroid-stimulating hormone (TSH) screening device used for the detection of hypothyroidism in adults. The company expects to announce a definitive agreement for the acquisition of ThyroTest very shortly, CLX said in a statement. ThyroTest is FDA-cleared and has also achieved Clinical Laboratory Improvement Amendments (CLIA)-waived status, so it can be administered in the more than 100,000 CLIA-waived doctors' offices in the United States, as well as in any nonwaived laboratory. CLX Medical also holds a 51% equity interest in Zonda Inc., which has developed several rapid point-of-care tests, including one for chlamydia.
Zentiva Agrees to Sanofi Takeover
The board of directors of Czech generic pharmaceutical maker Zentiva has agreed to recommend to shareholders that the company accept a takeover offer from Sanofi-Aventis for about $1.8 billion in cash. The price represents a 26% increase over the value of Zentiva stock on April 30, the last day of trading before the intention to make an offer was announced. Zentiva sells generic drugs in the Czech Republic, Slovakia, Romania, and Turkey, and is growing rapidly in Poland, Russia, Bulgaria, Hungary, the Ukraine, and the Baltic States, according to a statement by Sanofi. “Sanofi-Aventis believes that the operations of Zentiva present a compelling fit with this strategy and provide Sanofi-Aventis with a unique opportunity to accelerate its strategy in the markets that Zentiva serves,” the company said. “It is intended that Zentiva will become a platform for Sanofi-Aventis's further growth in the Central and Eastern European markets, focused upon providing affordable pharmaceuticals to patients in this region.”
NDA for Gencaro
ARCA Biopharma has filed a new drug application for Gencaro (bucindolol), which could be the first cardiovascular drug approved with an accompanying pharmacogenomic test, according to the company. “While currently available ?-blockers are a mainstay in medicine, it is difficult for physicians to predict which patients will respond to which therapy,” Michael Bristow, ARCA chairman, said in a statement. “Bucindolol interacts with certain polymorphism of adrenergic receptors that help regulate cardiac function, allowing us to predict patient clinical response using a simple genetic test.” Last year, ARCA signed a collaboration agreement with Laboratory Corporation of America, which is preparing a premarket approval application for the genomic test to submit to FDA's Center for Devices and Radiological Health.
Tethys Buys Lipomics Technologies
Diagnostics start-up Tethys Bioscience acquired Lipomics Technologies last month for an undisclosed sum. The purchase was thought to be made in order to shore up the technology expertise of the company, which launched its first diabetes risk assessment tool, PreDx, earlier this year. PreDx measures blood-borne biomarkers related to inflammation, lipid and carbohydrate metabolism, and coagulation to calculate a score identifying the patient's risk for developing diabetes. Lipomics specializes in profiling lipids, which can be evaluated in combination with proteins as an effective risk assessment tool for chronic conditions, according to Tethys. Lipomics's current business centers on contracting to perform biomarker research for drug company development projects, partnerships that could be helpful to Tethys's plan to establish drug-diagnostic comarketing agreements.
Shionogi Aims for Sciele Pharma
Japanese drugmaker Shionogi and Co. is planning to buy Atlanta-based Sciele Pharma for $1.42 billion—a transaction approved by both companies' boards, Shionogi announced last month. Sciele specializes in developing and marketing branded drugs that target cardiovascular health/diabetes, women's health, and pediatrics. Their products include novel formulations of off-patent drugs. “The acquisition is part of the medium- and long-term goals [at Shionogi] to establish a sales infrastructure in the U.S.,” a Shionogi spokesman said. The company's U.S. presence so far has been limited to Shionogi USA, a small subsidiary based in New Jersey, which was set up in 2001 to support drug development. The firm's primary revenue in this country has come from royalties on AstraZeneca's sales of Crestor (rosuvastatin), which was developed by Shionogi. Shionogi is offering $31 per share for Sciele, which represents a 60% premium over the company's average share price in recent months. The transaction is expected to close in the fourth quarter of 2008.
Reporters and editors from Elsevier's “The Pink Sheet” and “The Gray Sheet” contributed to this column.
CLX to Buy ThyroTest
CLX Medical has entered into a letter of intent with ThyroTec, LLC, to acquire ThyroTest, a rapid thyroid-stimulating hormone (TSH) screening device used for the detection of hypothyroidism in adults. The company expects to announce a definitive agreement for the acquisition of ThyroTest very shortly, CLX said in a statement. ThyroTest is FDA-cleared and has also achieved Clinical Laboratory Improvement Amendments (CLIA)-waived status, so it can be administered in the more than 100,000 CLIA-waived doctors' offices in the United States, as well as in any nonwaived laboratory. CLX Medical also holds a 51% equity interest in Zonda Inc., which has developed several rapid point-of-care tests, including one for chlamydia.
Zentiva Agrees to Sanofi Takeover
The board of directors of Czech generic pharmaceutical maker Zentiva has agreed to recommend to shareholders that the company accept a takeover offer from Sanofi-Aventis for about $1.8 billion in cash. The price represents a 26% increase over the value of Zentiva stock on April 30, the last day of trading before the intention to make an offer was announced. Zentiva sells generic drugs in the Czech Republic, Slovakia, Romania, and Turkey, and is growing rapidly in Poland, Russia, Bulgaria, Hungary, the Ukraine, and the Baltic States, according to a statement by Sanofi. “Sanofi-Aventis believes that the operations of Zentiva present a compelling fit with this strategy and provide Sanofi-Aventis with a unique opportunity to accelerate its strategy in the markets that Zentiva serves,” the company said. “It is intended that Zentiva will become a platform for Sanofi-Aventis's further growth in the Central and Eastern European markets, focused upon providing affordable pharmaceuticals to patients in this region.”
NDA for Gencaro
ARCA Biopharma has filed a new drug application for Gencaro (bucindolol), which could be the first cardiovascular drug approved with an accompanying pharmacogenomic test, according to the company. “While currently available ?-blockers are a mainstay in medicine, it is difficult for physicians to predict which patients will respond to which therapy,” Michael Bristow, ARCA chairman, said in a statement. “Bucindolol interacts with certain polymorphism of adrenergic receptors that help regulate cardiac function, allowing us to predict patient clinical response using a simple genetic test.” Last year, ARCA signed a collaboration agreement with Laboratory Corporation of America, which is preparing a premarket approval application for the genomic test to submit to FDA's Center for Devices and Radiological Health.
Tethys Buys Lipomics Technologies
Diagnostics start-up Tethys Bioscience acquired Lipomics Technologies last month for an undisclosed sum. The purchase was thought to be made in order to shore up the technology expertise of the company, which launched its first diabetes risk assessment tool, PreDx, earlier this year. PreDx measures blood-borne biomarkers related to inflammation, lipid and carbohydrate metabolism, and coagulation to calculate a score identifying the patient's risk for developing diabetes. Lipomics specializes in profiling lipids, which can be evaluated in combination with proteins as an effective risk assessment tool for chronic conditions, according to Tethys. Lipomics's current business centers on contracting to perform biomarker research for drug company development projects, partnerships that could be helpful to Tethys's plan to establish drug-diagnostic comarketing agreements.
Shionogi Aims for Sciele Pharma
Japanese drugmaker Shionogi and Co. is planning to buy Atlanta-based Sciele Pharma for $1.42 billion—a transaction approved by both companies' boards, Shionogi announced last month. Sciele specializes in developing and marketing branded drugs that target cardiovascular health/diabetes, women's health, and pediatrics. Their products include novel formulations of off-patent drugs. “The acquisition is part of the medium- and long-term goals [at Shionogi] to establish a sales infrastructure in the U.S.,” a Shionogi spokesman said. The company's U.S. presence so far has been limited to Shionogi USA, a small subsidiary based in New Jersey, which was set up in 2001 to support drug development. The firm's primary revenue in this country has come from royalties on AstraZeneca's sales of Crestor (rosuvastatin), which was developed by Shionogi. Shionogi is offering $31 per share for Sciele, which represents a 60% premium over the company's average share price in recent months. The transaction is expected to close in the fourth quarter of 2008.
Reporters and editors from Elsevier's “The Pink Sheet” and “The Gray Sheet” contributed to this column.
CLX to Buy ThyroTest
CLX Medical has entered into a letter of intent with ThyroTec, LLC, to acquire ThyroTest, a rapid thyroid-stimulating hormone (TSH) screening device used for the detection of hypothyroidism in adults. The company expects to announce a definitive agreement for the acquisition of ThyroTest very shortly, CLX said in a statement. ThyroTest is FDA-cleared and has also achieved Clinical Laboratory Improvement Amendments (CLIA)-waived status, so it can be administered in the more than 100,000 CLIA-waived doctors' offices in the United States, as well as in any nonwaived laboratory. CLX Medical also holds a 51% equity interest in Zonda Inc., which has developed several rapid point-of-care tests, including one for chlamydia.
Zentiva Agrees to Sanofi Takeover
The board of directors of Czech generic pharmaceutical maker Zentiva has agreed to recommend to shareholders that the company accept a takeover offer from Sanofi-Aventis for about $1.8 billion in cash. The price represents a 26% increase over the value of Zentiva stock on April 30, the last day of trading before the intention to make an offer was announced. Zentiva sells generic drugs in the Czech Republic, Slovakia, Romania, and Turkey, and is growing rapidly in Poland, Russia, Bulgaria, Hungary, the Ukraine, and the Baltic States, according to a statement by Sanofi. “Sanofi-Aventis believes that the operations of Zentiva present a compelling fit with this strategy and provide Sanofi-Aventis with a unique opportunity to accelerate its strategy in the markets that Zentiva serves,” the company said. “It is intended that Zentiva will become a platform for Sanofi-Aventis's further growth in the Central and Eastern European markets, focused upon providing affordable pharmaceuticals to patients in this region.”
NDA for Gencaro
ARCA Biopharma has filed a new drug application for Gencaro (bucindolol), which could be the first cardiovascular drug approved with an accompanying pharmacogenomic test, according to the company. “While currently available ?-blockers are a mainstay in medicine, it is difficult for physicians to predict which patients will respond to which therapy,” Michael Bristow, ARCA chairman, said in a statement. “Bucindolol interacts with certain polymorphism of adrenergic receptors that help regulate cardiac function, allowing us to predict patient clinical response using a simple genetic test.” Last year, ARCA signed a collaboration agreement with Laboratory Corporation of America, which is preparing a premarket approval application for the genomic test to submit to FDA's Center for Devices and Radiological Health.
Tethys Buys Lipomics Technologies
Diagnostics start-up Tethys Bioscience acquired Lipomics Technologies last month for an undisclosed sum. The purchase was thought to be made in order to shore up the technology expertise of the company, which launched its first diabetes risk assessment tool, PreDx, earlier this year. PreDx measures blood-borne biomarkers related to inflammation, lipid and carbohydrate metabolism, and coagulation to calculate a score identifying the patient's risk for developing diabetes. Lipomics specializes in profiling lipids, which can be evaluated in combination with proteins as an effective risk assessment tool for chronic conditions, according to Tethys. Lipomics's current business centers on contracting to perform biomarker research for drug company development projects, partnerships that could be helpful to Tethys's plan to establish drug-diagnostic comarketing agreements.
Shionogi Aims for Sciele Pharma
Japanese drugmaker Shionogi and Co. is planning to buy Atlanta-based Sciele Pharma for $1.42 billion—a transaction approved by both companies' boards, Shionogi announced last month. Sciele specializes in developing and marketing branded drugs that target cardiovascular health/diabetes, women's health, and pediatrics. Their products include novel formulations of off-patent drugs. “The acquisition is part of the medium- and long-term goals [at Shionogi] to establish a sales infrastructure in the U.S.,” a Shionogi spokesman said. The company's U.S. presence so far has been limited to Shionogi USA, a small subsidiary based in New Jersey, which was set up in 2001 to support drug development. The firm's primary revenue in this country has come from royalties on AstraZeneca's sales of Crestor (rosuvastatin), which was developed by Shionogi. Shionogi is offering $31 per share for Sciele, which represents a 60% premium over the company's average share price in recent months. The transaction is expected to close in the fourth quarter of 2008.
Reporters and editors from Elsevier's “The Pink Sheet” and “The Gray Sheet” contributed to this column.