I think the differentiator is going to be the device. If the first asthma albuterol device was a ntkr inhaler (looks like a bong but I don't think could work as a dual purpose device :-) and the next one out was a standard MDI puffer, which would win? So I think in the long run nktr will need a small device to compete. And the ardm device may not be much better, long run. alks/lly could be a darkhorse--very small device supposedly. I also wouldn't ignore mnkd, their ceo is a diabetes legend (founded Minimed). So call it a long term, 5 year type of prediction.
Alkermes Announces Lilly Decision to Proceed with Late-Stage Clinical Development Program for Inhaled Insulin
Tuesday, August 10, 2004
-- Cambridge, MA, August 10, 2004 -- Alkermes, Inc. (Nasdaq: ALKS) announced today that Eli Lilly and Company (“Lilly”) has made a positive product decision and will proceed with significant investment for the further development of an inhaled formulation of insulin. The decision follows the successful execution of several critical steps: the completion and analysis of data from a Phase 2 study; the achievement of commercial manufacturing powder production scale-up; and the development and testing of the commercial pulmonary insulin inhaler system. Development activities will include both clinical trials and additional manufacturing activities for the inhaler system and the production facility.
A recently completed Phase 2 clinical trial for inhaled insulin using Alkermes’ AIR® technology showed that patients with type 1 diabetes achieved glycemic control levels similar to injected insulin. The trial was a multi-center, cross-over design study with 120 patients with type 1 diabetes receiving an inhaled formulation of insulin using AIR technology for a three-month period. Inhaled insulin had a rapid onset of action and was well tolerated with adverse events similar in both treatment arms.
“We’re delighted that the strength of the clinical data and our achievement of commercialization milestones provided the basis of the decision by Lilly to move forward with further development for inhaled insulin,” said Elliot Ehrich, M.D., Chief Medical Officer at Alkermes. “We look forward to initiating additional clinical studies that will bring us another step closer to developing an important new treatment for the growing number of people living with diabetes.”
The inhaled insulin delivery system is based on Alkermes’ AIR pulmonary drug delivery technology, which uses a small, easy-to-use, inhaler designed to provide drug delivery for a wide range of drug doses. Alkermes and Lilly have collaborated on the inhaled insulin program since 2001 to develop an innovative treatment option for people with diabetes.
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