FDA Approves Amylin Diabetes Drug

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The FDA granted approval Friday for Bydureon, a once weekly version of the Amylin (NASDAQ: AMLN) diabetes drug Byetta. The longer lasting dosage was made possible using dosage techniques created by Alkermes (NASDAQ: ALKS), which will receive 8% of the profits. Amylin closed Monday up over 17% to $14.26. Bydureon will have its official release next month.

Byetta and Bydureon both contain the active ingredient exenatide, a synthetic version of a hormone found in Gila monster saliva.  Exenatide encourages the production of insulin in pancreatic beta cells when blood sugars are too low and regulates excess insulin to bring down elevated blood sugar. Dosage of each drug is done via injection; Byetta required twice-daily shots administered approximately one hour before a meal. Bydureon dosage doesn’t need to be timed around a meal due to its extended release nature.

Bydureon production began under a partnership between Amylin and Eli Lilly (NYSE: LLY) that was similar to one the company’s had for Byetta. The duo submitted Bydureon to the FDA in the spring of 2009 but the FDA requested additional information regarding efficacy and risks. The submitted information still didn’t satisfy the FDA and Amylin was forced to return to clinical trials to demonstrate the drug doesn’t carry cardiac risks. During the documentation back and forth, the partnership between Amylin and Eli Lilly went south, leading to a lawsuit and settlement that entitles Eli Lilly to a capped royalty amount from sales of Bydureon.

The drug will be released with a warning that it shouldn’t be prescribed to individuals with a history of medullary thyroid carcinoma, which stems from clinical trial rats that developed thyroid tumors. Amylin is required to conduct another clinical study, following the release of Bydureon, to further study potential cardiac and thyroid risks. Results from that study have to be turned in to the FDA by 2018.

 It’s reported that Bydureon may produce revenues exceeding $1 billion within three years of its release. Amylin may not make it that long without some financial assistance.  The company lost a lucrative partner in the Eli Lilly fallout and faces billions in debt with hundreds of millions in cash. Despite Monday’s optimistic bump, investors may want to hold back to see how Amylin plans to sturdy itself.



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