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Sector Snap: New Diabetes Drugs Under FDA Review

Thu, 03/26/2009 - 9:25am
NEW YORK (AP) — Several companies jockeying for position in the growing diabetes drug market will face Food and Drug Administration reviews in the coming months that could determine which treatments are poised for success. On April 1, an FDA advisory panel will review Bristol-Myers Squibb Co. and AstraZeneca's candidate saxagliptin, with a review of Novo Nordisk's liraglutide on April 2. Recommendations from these panels will likely determine whether the drugs gain marketing approval, while also giving a hint of how well they will perform in the market. Meanwhile, Amylin Pharmaceuticals Inc. with partners Eli Lilly & Co. and Alkermes Inc. still plan to ask for approval of the extended-release version of Byetta, called exenatide LAR, during the second quarter. But that application will come amid tougher safety review standards for new diabetes drugs, with the FDA more focused on heart risks. The agency wants companies developing diabetes drug to include safety data on patients at higher risk of heart attacks or strokes. The increased scrutiny follows related safety concerns with GlaxoSmithKline's diabetes drug Avandia two years ago, after a medical journal suggested the drug could increase the risk of heart attacks and heart-related deaths. If approved, Novo's once-daily injection liraglutide is expected to be a heavy competitor with Amylin's current twice-daily injection Byetta and the extended LAR version, which is injected once weekly. Both Byetta and liraglutide are part of the GLP-1 class, which controls blood sugar. Meanwhile, Bristol-Myers' DPP-4 inhibitor saxagliptin would compete directly against Merck & Co.'s blockbuster Januvia. Though the drug pairings use different methods to control blood-sugar levels, they all have the same goal, which will make for a crowded field of competitors. The heart risk concern still hangs over Amylin, according to Citi analyst Dr. Yaron Werber. The company plans to use data gleaned from reviewing past study results on Byetta instead of clinical trial data from exenatide. "This analysis was done in a manner consistent with the FDA updated guidance for evaluating cardiovascular risk in type 2 diabetes agents," the company said in a statement Thursday. The results suggest there is no increased risk with Byetta, Amylin said. Still, Werber remained concern that the data could be rejected because it includes studies that have only three months of data and is retrospective. "It is not clear if the FDA will accept the argument that a cardiovascular analysis for Byetta replaces an analysis for LAR," Werber said in a note to investors. Shares of San Diego-based Amylin rose 56 cents, or 4.5 percent, to $13.03, while Alkermes gained 91 cents, or 7.9 percent, to reach $12.46 in afternoon trading. Indianapolis-based Eli Lilly gained 3 cents to reach $33.56. Shares of Denmark-based Novo Nordisk rose $1.70, or 3.5 percent, to $50.32, while shares of New York-based Bristol-Myers fell 10 cents to $20.96 and London-based AstraZeneca fell 51 cents to $33.11.
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