Eli Lilly Terminates AIR Insulin Program - Pharmaceutical Technology

Latest Issue

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.”


blog comments powered by Disqus
LCGC E-mail Newsletters

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

FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
View Results
Eric Langerr Outsourcing Outlook Eric LangerTargeting Different Off-Shore Destinations
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerAsymmetric Synthesis Continues to Advance
Jill Wechsler Regulatory Watch Jill Wechsler Data Integrity Key to GMP Compliance
Sean Milmo European Regulatory WatchSean MilmoExtending the Scope of Pharmacovigilance Comes at a Price
From Generics to Supergenerics
CMOs and the Track-and-Trace Race: Are You Engaged Yet?
Ebola Outbreak Raises Ethical Issues
Better Comms Means a Fitter Future for Pharma, Part 2: Realizing the Benefits of Unified Communications
Better Comms Means a Fitter Future for Pharma, Part 1: Challenges and Changes
Source: ePT--the Electronic Newsletter of Pharmaceutical Technology,
Click here