Yesterday, the company announced results of a phase 3 trial testing the ability of its diabetes drug BYETTA to lower glucose levels without the help of other drugs. The results weren't stellar, but 60% of patients taking the BYETTA were able to reduce their glucose levels below the target level.
The drug is currently only approved for use in combination with other oral medications, since the FDA rejected its request to be used as a stand-alone treatment in 2005.
Amylin and marketing partner Eli Lilly
BYETTA does have the advantage of contributing to weight loss in patients, but I'm not sure that the added benefit will justify the patients' anxiety of having to inject themselves twice a day.
The real benefit of getting an expanded label now is that the company can use that label when it applies for a marketing application for Exenatide once weekly, its extended release version of BYETTA. The drug, developed using Alkermes'
While 730 injections per year -- 732 in leap years -- will probably keep most patients from using the drug as a first choice, 52 injections of Exenatide per year might be a decent trade-off for not having to remember to take a pill twice a day.
It looks like the Mack truck is gassed up and ready to grab on to the label-expanding cart when Amylin steps on the gas.
More Foolishness on diabetes drugmakers:
Fool contributor Brian Orelli, Ph.D., doesn't own shares of any company mentioned in this article. Eli Lilly is a selection of the Income Investor newsletter. The Fool's disclosure policy is as slim as a piece of paper.