Amylin seeks FDA OK on once-weekly diabetes drug

[May 06, 2009]  NEW YORK (AP) -- Biotechnology company Amylin Pharmaceuticals Inc. said Tuesday it asked the Food and Drug Administration to approve its highly anticipated once-weekly injectable diabetes treatment exenatide LAR.

The drug is an extended version of the twice-daily injectable drug Byetta, a version of a protein found in Gila monster saliva, and is being viewed by Wall Street as a way for Amylin to reinvigorate sales. Byetta sales fell 32 percent in 2008 to $430.2 million because of safety concerns.

Because the drugs are injections, the much lower dosing schedule with exenatide LAR is seen as a commercial advantage.

The drug's competition would likely include Novo Nordisk's once-daily injection liraglutide, which is currently under FDA review.

Drugs that help diabetics control blood sugar are a hot area for developers because the drugs must be taken long-term to control the chronic condition. The U.S. market for diabetes drugs is worth about $5 billion per year.

Meanwhile, San Diego-based Amylin Pharmaceuticals Inc. is cutting about 200 jobs, or more than a third of its sales force, as it combines primary care and specialty drug sales units.

The company's partners on Byetta and exenatide LAR include Indianapolis-based Eli Lilly & Co. and Cambridge, Mass.-based Alkermes Inc.

Denmark-based Novo Nordisk received a split recommendation from its expert panel review at the FDA, with members expressing safety concerns over tumors associated with liraglutide. The FDA is not required to follow its panels' advice, though it normally does.

The FDA issued new safety guidelines for diabetes treatments last year after concerns about heightened risks of heart attack with GlaxoSmithKline's blockbuster pill Avandia created a storm around the agency and the British drugmaker in 2007.

Both exenatide LAR and liraglutide are part of the same class of diabetes treatments, called GLP-1 analogues. They help increase the body's insulin production.

Amylin shares rose 70 cents, or 6 percent, to $12.28 in morning trading while Alkermes shares jumped $1.46, or 18.6 percent, to $9.31. Eli Lilly shares rose 52 cents to $34.33.

[Associated Press; By DAMIAN J. TROISE]

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