PHARMACY

Pfizer, Bristol-Myers team up on treatment for metabolic disorders

BY Drew Buono

NEW YORK Pfizer and Bristol-Myers Squibb have reached an agreement on a worldwide alliance to research, develop and commercialize DGAT-1 inhibitors. The DGAT-1 inhibitors program includes compounds with applications for the treatment of metabolic disorders, including obesity and diabetes.

Pfizer will conduct all research and early-stage activities for the metabolic disorders and the companies will work together on Phase III development and commercialization activities.

DGAT-1 (diacylglycerol acyl transferase-1) is an enzyme critical to the creation of triglycerides and fat storage. Overweight and obese people have significantly greater triglyceride levels, making them more likely to get diabetes and its associated metabolic complications.

According to Elliot Sigal, chief scientific officer and president, Research and Development, Bristol-Myers Squibb, “This collaboration underscores the company’s commitment to investing in research and development, and reflects our strategy to identify partnerships that complement our own research efforts to enhance our innovative pipeline.”

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PHARMACY

Teva receives final FDA approval for generic Famvir, but will delay marketing until patent hearing

BY Drew Buono

JERUSALEM Teva Pharmaceuticals has been granted final approval on its application to market famciclovir, the generic version of Novartis’ Famvir in the 125, 250 and 500mgs.

Now with the approval from the Food and Drug Administration, Teva is also awarded a 180-day period of market exclusivity. But the company will hold off marketing the item until at least Sept. 5, 2007.

On that day, a hearing will be held involving a patent infringement suit brought against Teva regarding the famciclovir. The hearing is scheduled to meet at the U.S. District Court for the District of New Jersey regarding Novartis’ motion for a preliminary injunction. Therefore, both parties have agreed to not launch a generic version of Famvir until after the hearing.

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Forest, Daiichi Sankyo sign agreement for Azor

BY Drew Buono

NEW YORK Forest Laboratories and Daiichi Sankyo have signed a co-promotional agreement for Daiichi Sankyo’s new antihypertension drug Azor. Azor is a combination of the calcium channel blocker amlodipine besylate and the angiotensin receptor blocker olmesartan medoxomil.

Under the agreement, Forest will pay Daiichi Sankyo an upfront payment of $20 million and will receive a payment based upon product sales. The agreement is for three years, after which, Daiichi Sankyo will make residual payments to Forest.

The drug is still under review by the Food and Drug Administration with a decision expected by late September. Hypertension affects roughly 72 million people in the U.S., with about 65 percent of those diagnosed having trouble keeping it under control.

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