Lilly Ends Insulin Program

Eli Lilly and Co. terminated its AIR Insulin development program with partner Alkermes, Inc. The program has been in Phase III development as a potential treatment for type 1 and type 2 diabetes. According to the company, the decision is not related to the safety of the product, but due to regulatory concerns and the commercial potential of the product compared to existing therapies.
   
“This decision, though difficult, is the right one to make at this time,” commented John Lechleiter, Ph.D., Lilly president and chief operating officer. “Over the past several months we have conducted a thorough review of all aspects of our efforts to develop our AIR Insulin product and have now made the decision that it would be inappropriate for the company to continue development activities in connection with this project. Without the prospect of a new drug application, keeping the patient foremost in mind, it would not be consistent with our medical principles to continue the clinical trials. As a result, we are now beginning the process of halting our ongoing clinical studies and transitioning the AIR Insulin patients in these studies to other appropriate therapies. We wish to reassure patients currently receiving AIR Insulin in our ongoing clinical trials that they should have no health or safety concerns about continuing to use AIR Insulin during their transition to other well-established diabetes therapies.”
   
Subject to protocols, the trials will be stopped and the patients currently enrolled will be moved to other insulin therapies. In the U.S., Lilly will implement a patient assistance program to provide trial patients with financial support to fund their medications and diagnostic supplies through the end of 2008.  
   
The termination of the development program will result in a 1Q08 charge to earnings and costs estimated to be in the range of $90 – $120 million.