Byetta LAR Great Results – What Next?

Byetta LAR Great Results – What Next?

Yesterday afternoon Amylin Pharmaceuticals (NASDAQ:AMLN) announced results from Phase 2 study for the long acting version of Byetta known as Byetta LAR. The results weren’t good were great. Of the 14 participants in the study 12 achieved an A1C of 7 percent or less at 15 weeks. (A1C is considered the gold standard for measuring control and the American Diabetes Association (ADA) maintains that an A1C of 7% or below is defined as good control. Numerous studies have indicated that patients who can maintain A1C levels at or below 7% can avoid many of the serious complications associated with diabetes.) According to the company the decrease in A1C was progressive with no evidence of a plateau at week 15. Not surprisingly shares of Amylin have skyrocketed on the news up nearly $6 at $27.90.

Byetta LAR is a once a week dosing regimen compared to the twice daily dosing for the recently approved version of Byetta. Diabetic Investor has long maintained that the long acting version of Byetta is the hidden gem in Amylin’s pipeline. Should this version gain approval, something we see as a likely event, the drug will have a major impact on how patients with Type 2 diabetes are treated. It would not be an understatement to say that Byetta LAR will cause a paradigm shift in the market for Type 2 drugs.

Many had questioned how patients and physicians would react to an injectable drug when the majority of Type 2 patients were on oral medications. Although the current version of Byetta has only been available for a short period of time, weekly prescription data shows prescriptions accelerating. As Diabetic Investor predicted the fact that Byetta must be injected twice daily would not be a problem once patients and physicians saw how effective the drug is. Add in the fact that patients on Byetta show progressive weight loss and what you have is blockbuster potential. Given that the long acting version of Byetta is injected just once a week and you have mega blockbuster potential.

This is great news for Amylin and bad news for Lantus, a long acting insulin from Sanofi-Aventis (NYSE:SNY), currently the number one selling insulin in the world. It is also bad news for the many oral medications on the market. Although Byetta is not yet approved as a mono-therapy the drug is being used this way and Diabetic Investor believes the drug will receive this indication in the near future.

With Byetta performing above expectations, the positive outlook for Byetta LAR and Amylin’s strong pipeline their partner with Byetta Eli Lilly (NYSE:LLY) may decide to make a bid for the company sooner rather than latter. The longer they wait to make a move the more expensive the acquisition will become. A very pleasant thought for Amylin shareholders indeed.

David Kliff
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