Amylin Pharmaceuticals (Nasdaq: AMLN) will forever be a reminder to biotech investors that blockbuster product approval does not guarantee anything in the market. Once a darling because of its first-in-class GLP-1 analog Byetta for diabetes, Amylin has had a rough go of it in the face of competitive offerings, regulatory setbacks, and internecine wars with a former partner.
For all of the drama, though, there may yet be potential in this battered biotech.
Bydureon – Is Third Time The Charm?
Bydureon, a once-weekly injected drug otherwise similar to Byetta, has long been the crown jewel in Amylin's vault but the company has struggled to bring it to market. Not only did a marketing study comparing Bydureon with Novo Nordisk's (NYSE: NVO) once-daily Victoza fail to show non-inferiority (meaning Victoza works better), but the FDA has twice rejected this drug within the past two years.
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The New Amylin - More Risk, More Potential
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