PHARMACY

Teva to acquire CoGenesys for $400 million

BY Drew Buono

JERUSALEM Teva has entered into a definitive agreement to acquire the biotech company CoGenesys, in a deal worth $400 million cash. The deal focuses on the development of peptide and protein based medicines across broad therapeutic categories.

In its recently completed strategic review, Teva identified biopharmaceuticals and primarily biogenerics as a key, long-term growth opportunity for the company. With this acquisition, Teva is taking a step towards becoming a leading player in the biogenerics market, as that market evolves.

“We are very excited about this strategic acquisition. Biopharmaceuticals will be a long-term growth driver for Teva, and this transaction represents an important springboard in our efforts to establish ourselves among the leaders in this market. CoGenesys’ breadth of technologies and the depth of their team and pipeline complement Teva’s large-scale operations, extensive resources and its proven expertise in bringing drugs to market,” said Shlomo Yanai, Teva’s president and chief executive officer, commenting on the transaction. “This combination will enable us to realize our vision of delivering high quality, affordable biopharmaceuticals worldwide. CoGenesys’ acquisition reflects our commitment to capture the significant long-term prospects we believe the biogenerics market will offer.”

The deal is expected to close during the first half of 2008.

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PHARMACY

FDA updates labeling for birth control patch to reflect risk of blood clots

BY Drew Buono

WASHINGTON The Food and Drug Administration has approved additional changes to the labeling for the Ortho Evra patch, made by Ortho McNeil Pharmaceuticals, to include the results of a new study that found users of the birth control patch were at higher risk of developing serious blood clots, also known as venous thromboembolism, which can lead to a pulmonary embolism.

The Boston Collaborative Drug Surveillance Program on behalf of Johnson & Johnson conducted the study. The patch was studied in women aged 15-44. These recent findings support an earlier study that also said women in this group were at higher risk for VTE.

Ortho Evra is a prescription patch that releases the hormones ethinyl estradiol and norelgestromin through the skin into the blood stream. Because the hormones are processed by the body differently than hormones from birth control pills, women using the product will be exposed to about 60 percent more estrogen than if they were using typical birth control pills containing 35 micrograms of estrogen. Increased levels of estrogen may increase the risk of side effects, including VTE.

Women should discuss with their health care providers the possible increased risk of VTE with Ortho Evra, which is applied once a week, and balance this risk against the increased chance of pregnancy if women do not take their birth control pill daily.

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Study shows Avodart/Flomax combo more effective on enlarged prostate problems

BY Drew Buono

PHILADELPHIA A new study that will be published in the Journal of Urology shows that men with enlarged prostates who took a combination of two medications, Avodart and tamsulosin hydrochloride, the generic version of the Astellas Pharma/Boehringer Ingelheim drug Flomax, experienced greater improvements in urinary symptoms than men prescribed either medication alone, according to published reports.

Over time, Avodart (dutasteride) shrinks the prostate, improves symptoms and arrests the enlarged prostate disease process. Tamsulosin is an alpha-blocker that relaxes the muscles in the bladder and prostate.

The study, entitled The Combination of Avodart and Tamsulosin, looked at male patients with moderate-to-severe enlarged prostate symptoms received a placebo for four weeks and then were randomized to receive Avodart and tamsulosin as combination therapy, for the remaining 24 months of the study.

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