An update from the NewsMakers in Biotech conference in NYC on an item of intense interest. Amylin Pharmaceuticals just held a well-attended PowerPoint presentation followed by a very cramped breakout session. And pretty much the only thing investors and analysts wanted to talk about is Byetta LAR (long-acting release).I recently blogged that one analyst says the test results on this drug are the most highly-anticipated data in biotech for the second half of this year.
CEO Dan Bradbury reiterated that the late-stage data are expected in the fourth quarter of this year. Bradbury declined under persistent questioning in the q and a breakout session to give a timeline for filing for FDA approval of Byetta LAR. It's a once-a-week version of the drug which Amylin and Lilly sell as a twice-a-day injectable right now. Alkermes makes the technology to stretch it out over a week.
Bradbury also candidly acknowledged that sales of Byetta are not "growing at the rate we want them to grow." He blamed the sluggishness primarily on the learning curve facing general practitioners, but added that the company is stepping up its free samples and educational efforts.
Just yesterday FBR biotech analyst Jim Reddoch in a research note to clients dropped his third quarter Byetta sales estimate to $6 million below the consensus on the Street. He wrote, "...even though (Byetta) is a great drug...(it's) hitting the wall..." But he added that if the Byetta LAR data are good that it could become a $3 billion-a-year drug. Wall Street waits.
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