Eli Lilly Terminates AIR Insulin Program - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

Eli Lilly Terminates AIR Insulin Program


ePT--the Electronic Newsletter of Pharmaceutical Technology

Untitled Document

Indianapolis, IN (Mar. 7)—Eli Lilly terminated the development of its inhaled insulin product AIR, a diabetes treatment that had been in Phase III clinical trials. In a March 7 press release, Lilly’s president and chief operating officer John Lechleiter stated that the decision was due to an uncertain regulatory environment, saying, “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.”

Quelling concerns of patients involved in the clinical trials, Lilly stressed its decision was not based on product safety. Lechleiter reassured that “patients currently receiving AIR Insulin in our ongoing clinical trials should have no health or safety concerns about continuing to use AIR Insulin during their transition to other well-established diabetes therapies.” Lilly’s executive vice-president of science and technology, Steven M. Paul, reaffirmed that “our decision is not due to any safety concerns observed by Lilly or raised by the independent data safety monitoring board.” Lilly plans on implementing a patient assistance program to provide trial patients in the US with financial support to help fund medications and diagnostic supplies through the end of 2008. Paul says Lilly “remains committed to our mission to develop innovative, beneficial, and cost-effective treatments for diabetic patients.”

AIR was a joint project between Lilly and Alkermes. In a statement released on March 7, Alkermes stated that Lilly was within its rights to terminate its license to AIR Insulin but that Alkermes believes Phase III safety and efficacy trials should be completed to provide patients, physicians, and scientists with more information on inhaled insulin and other diabetes medications.

While Lilly, Pfizer, and other companies have discontinued similar products, MannKind, which is developing its own version of inhaled insulin, issued a statement on March 10 that it was committed to developing its product and believes that its “small, patient-friendly ‘Medtone’ inhaler delivers ‘Technosphere Insulin’ to patients with diabetes in a way that much more closely matches the pattern of insulin secretion seen in people without disease.”

ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
What role should the US government play in the current Ebola outbreak?
Finance development of drugs to treat/prevent disease.
Oversee medical treatment of patients in the US.
Provide treatment for patients globally.
All of the above.
No government involvement in patient treatment or drug development.
Finance development of drugs to treat/prevent disease.
26%
Oversee medical treatment of patients in the US.
13%
Provide treatment for patients globally.
10%
All of the above.
41%
No government involvement in patient treatment or drug development.
10%
Jim Miller Outsourcing Outlook Jim MillerCMO Industry Thins Out
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerFluorination Remains Key Challenge in API Synthesis
Marilyn E. Morris Guest EditorialMarilyn E. MorrisBolstering Graduate Education and Research Programs
Jill Wechsler Regulatory Watch Jill Wechsler Biopharma Manufacturers Respond to Ebola Crisis
Sean Milmo European Regulatory WatchSean MilmoHarmonizing Marketing Approval of Generic Drugs in Europe
FDA Reorganization to Promote Drug Quality
FDA Readies Quality Metrics Measures
New FDA Team to Spur Modern Drug Manufacturing
From Generics to Supergenerics
CMOs and the Track-and-Trace Race: Are You Engaged Yet?
Source: ePT--the Electronic Newsletter of Pharmaceutical Technology,
Click here