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Susan Haigney is managing editor of Pharmaceutical Technologyand Pharmaceutical Technology Europe, email@example.com.
Eli Lilly terminated the development of its inhaled insulin product AIR, a diabetes treatment that had been in Phase III clinical trials.
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.”