Amylin Cuts Workforce, Asks FDA to Approve Once-Weekly Byetta

It has been an interesting month for San Diego-based Amylin Pharmaceuticals Inc., the co-manufacturer of Byetta (exenatide) with Eli Lilly & Co., and Alkermes Inc. First, the company announced that it will reduce its sales force by 35 percent-200 employees-in hope of saving $20 million this year and $45 million annually starting in 2010. The company plans to retain 325 representatives to sell its diabetes products to doctors and endocrinologists. At the same time, Amylin has petitioned the FDA to approve the marketing of Byetta LAR, a form of the type 2 drug that requires injection only once a week.

The employee cutback was not unexpected. Large pharmaceutical companies across the board are trimming their sales staffs in the wake of lagging drug sales. Amylin, however, has also been hit with a notable drop in Byetta sales since 2008, when the FDA began questioning whether the drug might be a causative factor in several deaths from severe pancreatitis.

The agency’s concerns about the drug’s safety caused a 32 percent drop in sales last year, from $635 million to $430 million. Amylin is hoping that Byetta LAR will rejuvenate the market for the drug, especially given the attraction of injecting the drug once a week instead of twice daily. The U.S. market for diabetes drugs is estimated at $5 billion per year, and some analysts say that Byetta LAR, which would be the first long-acting diabetes drug on the market, could push Byetta sales past the $1 billion mark.
The fly in the ointment for Amylin and its partners is that the FDA has intensified its scrutiny of diabetes drugs ever since GlaxoSmithKline’s popular Avandia was associated with an increased risk of heart attack in 2007. Since then, the agency has been slower to approve drugs and has added new performance benchmarks to its requirements.

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