Lilly Abandons Inhaled Insulin

Alkermes Inc. announced Friday that partner Eli Lilly & Co said it was pulling out of a pact to develop an inhaled insulin product called AIR over concerns that it might not be able to show the product provides a clear benefit over traditional, injected insulin. Alkermes had provided the drug delivery technology for AIR, which was in Phase III clinical trials. Lilly said that it plans to discontinue the trials, despite a request from Alkermes that they continue.

Eli Lilly and Company has informed Alkermes, that it was reviewing the "business case" for the product, known as AIR. Currently in Phase III testing, AIR utilizes Cambridge, Mass.-based Alkermes’ drug-delivery technology. But, the final decision has already been made so it looks very unlikely that Eli Lilly will continue its partnership.

In a statement Friday, Alkermes said it hoped that Lilly would continue to support the ongoing Phase III clinical trials, asserting data would be of substantial value to the medical community.

The news from Alkermes also rattled investors with holdings in Mannkind Corp.
Mannkind corp, which is also working on a proprietary inhaled-insulin product. If Lilly does end its involvement in the project, which is very likely,  it would become the third major pharmaceutical maker to abandon inhaled insulin, once considered a potential breakthrough in diabetes care. In January, leading insulin maker Novo Nordisk announced it was shelving its inhaled-insulin program, saying it didn’t believe the product in its current form offered any real advantages. The Danish drugmaker had been developing the product, called AERx, with Aradigm Corp), another drug-delivery developer.

In a related news release MannKind has stated that it is absolutely committed to the continued development of its lead development product, Technosphere® Insulin.  MannKind as stated in their news release, that their product can offer improved efficacy and safety, not just improved convenience. There product has also demonstrated, a significant reduction in post-prandial glucose excursions with out the risk of hypoglycemia and weight gain.  Along with their inhaled insulin they are also working on an inhaled GLP-1 compound.

And last fall, Pfizer Inc. surprised many investors by announcing it planned to stop marketing its new inhaled-insulin product, called Exubera, citing poor sales. Pfizer had developed Exubera with drug-delivery specialist Nektar Therapeutics, which has since said it is actively seeking a new marketing partner for the product. One major perceived drawback of Exubera was its inhalation device, which was repeatedly criticized as being too large and cumbersome. Eli Lilly and Alkermes, meanwhile, had touted the AIR device as being considerably smaller and easier to use.

Exubera’s failure left many disappointed, who thought inhaled insulin would be a sure-fire success, in light of the sharp rise in diabetes cases diagnosed over the past few years. The idea of inhaled insulin was also highly appealing the diabetes community. Traditional insulin products require refrigeration and are administered up to several times a day by needle, which can be uncomfortable and highly inconvenient. Inhaled insulin, on the other hand, generally requires no refrigeration and is administered using a device that in some cases resembles a large asthma inhaler or nebulizer. However, once it was launched, Exubera met with unexpected resistance from the medical community.
Many doctors were reportedly leery of prescribing the product because of lingering concerns about the potential long-term impact of insulin on the lungs. Others worried that the product wouldn’t work as predictably as injected insulin. Insulin can be dangerous if taken at the wrong dosages.

Health insurers also were reportedly not sold on the product, which is considerably more expensive than injected insulin.

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FACT:

JAMA Study Shows Change In Lifestyle Habits Helps Maintain Weight Loss: Nearly two thirds of adults in the U.S. are overweight or obese, a condition that often leads to high blood pressure and diabetes.  Now a new study indicates certain lifestyle changes are helping some people lose pounds and keep the weight off.  Researchers studied about a thousand overweight and obese adults.  Participants were taught lifestyle changes such as reducing daily calories, increasing moderate exercise, eating a well balanced diet and keeping track of calories and activity.  By changing lifestyle habits participants in the study were able to lose about twenty pounds during the initial six month weight loss program and the majority were able to maintain their weight loss. JAMA, March 2008