Amylin Pharmaceuticals Motto: Try, Try, and then Try Again
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If first you don't succeed, try again. If you still don't succeed, try for number three. It seems like the third time's a charm for drug maker, Amylin Pharmaceuticals (NASDAQ: AMLN).
Roughly 26 million Americans and 285 million people worldwide suffer from diabetes. Some of these folks are going to be awfully glad that Amylin Pharmaceuticals didn't give up.
Bydureon, one of the most anticipated new drugs in the history of diabetes medications, was given a nod by the Food and Drug Administration (FDA) on Friday. Amylin, along with its partner, Alkermes (NASDAQ: ALKS), will now be able to market its once-a-week injectible diabetes drug for the treatment of Type 2 diabetes.
Amid the announcement and just before 2 p.m. on Friday, shares of both drug company stocks were halted. But after the market's close, shares of both Amylin and Alkermes received favorable gains. Amylin stock price increased almost 15 percent to $13.94 a share, while Alkermes shares increased to $20 a share -- up five percent in after-market trading. Both Amylin and Alkermes shares are expected to see active trading on Monday.
Amylin's Road to Bydureon's Approval
Amylin tried to receive FDA approval on Bydureon twice before, but hurdles stood in its way. One obstacle in getting earlier approval was the FDA's concern over the possibility that the drug caused heart rhythm abnormalities. Future drug studies revealed no evidence of such heart problems resulting from Bydureon.
During its long, rough road (Amylin began its Bydureon approval battle in May of 2009) to Bydureon's FDA approval, Bydureon severed its long-term ties with diabetes-drug partner Eli Lilly & Co. (NYSE: LLY), which means that Amylin has to sell the drug solo in the United States. Bydureon is already for sale in Europe, where Amylin is looking to replace Eli Lilly's commercial sales efforts with a new marketing partner.
Bydureon doesn't come without it risks, however. In a prominent warning box on the drug's label, patients are warned of the risks of thyroid c-cell tumors. Other warnings include risks of pancreatitis, hypoglycemia, and renal insufficiency.
Bydureon offers more convenience than Amylin's existing drug, Byetta, which is injected twice a day for blood glucose monitoring control.
Meanwhile, Amylin has some catching up to do with Novo Nordisk (NYSE: NVO). Novo has been selling its rival GLP-1 diabetes drug, Victoza, to the tune of $1 billion sales worldwide annually. And Amylin indeed has some work to do considering the study that put Bydureon and Victoza head-to-head. The study's findings: Bydureon didn't control blood glucose as well as Novo's Victoza.
But because Victoza must currently be injected daily, Bydureon may have an edge out of convenience.
Good or bad, Novo has recently been involved in a controversy for reportedly hiring Paula Dean as a spokesperson for its diabetes drug.
And so it begins: Amylin and Novo Nordisk begin their combat. Novo's sales reps will no doubt tout the Victoza's win in the head-to-head battle with Bydureon, while Amylin's has the once a week convenience selling point.
Which selling point is more important to diabetics? It will be a closely watched competition to find out.
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