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Byetta: What We Know Right Now

For some time now I've been occasionally blogging about the data on a once-a-week version of Byetta that are expected in the fourth quarter sometime. This is a long-acting release (LAR, for short) version of the current twice-a-day injectable drug for diabetes from Lilly and Amylin. Alkermes makes the technology that extends the drug's release. Amylin and Alkermes were rallying earlier today on an analyst upgrade of AMLN, but have since pulled back.

Lazard Capital Market's Matthew Osborne upped AMLN from Hold to Buy and his price target to 58 bucks. In the research note to clients he writes, "Despite the 15% appreciation in AMLN shares since July, we believe there's 20% upside from here…" Lazard makes a market in Amylin. Osborne now projects that Byetta LAR will hit $4.2 billion in worldwide sales in 2012. That's the biggest number I've seen. The analyst is basing his bullishness on recent conversations with endocrinologists (diabetes specialists) who claim their use of Byetta would double if the LAR data look good.

On the downside, though, he points out that if the companies win FDA approval of Byetta LAR, that their first "delivery system"--the way the drug is administered--won't be their most user-friendly. In other words, it'll be a vial with the drug inside and a pretty big needle versusthe stick pen patients use with the twice-a-day dose that's injected into the belly.

At the BioCentury Newsmaker in Biotech conference last week, Amylin CEO Dan Bradbury said the company would "focus on being early to market even without an optimal delivery system." In other words, it would launch the product with a vial and syringe.

There's no specific date or a narrow timeframe for the highly-anticipated data release. All we know is that it's supposed to come out sometime in Q4.

Questions? Comments? Pharma@cnbc.com