Thursday, March 11, 2010

FDA's magic wand pointing at Amylin's longer acting Byetta

As the FDA sits literally hours away from okaying the once-weekly Byetta (exenatide) co-developed by Amylin (AMLN), Eli Lilly & Co. (LLY), and Alkermes (ALKS), industry followers are holding their breath and betting on dramatic boost in stock prices of the 'renewed' Byetta's developers. Seeing that the twice-daily formulation of the GLP-1 analog was able to capture $700 million in annual sales, the revised version of the drug (Byetta LAR), requiring merely 1 injection per week (as opposed to 14 injections), is likely to be quickly embraced by the Type 2 diabetes community. If approved, the new medicine is estimated to rake in peak sales of $2 billion by 2017 according to a JP Morgan Analyst.

While approval of Byetta LAR seems utterly inevitable, analysts are split on this one. This is partly because 1) the FDA has been known to surprise the crowd in the past and may either delay the final decision or request for additional information and 2) previous records have linked GLP-1 analog to pancreatitis, renal failures, and thyroid cancer (see Novo Nordisk's Victoza, a once-daily GLP-1 agonist approved earlier this year).

Despite the skepticism, Daniel Bradbury, Amylin's CEO, is confident about the success of the approval. Will the magic work for him?

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