March 17, 2008

Volume 86, Number 11

p. 9

Pharmaceuticals

Lilly Drops Inhaled Insulin

Move adds to growing list of failures for the technology

Lisa Jarvis

ELI LILLY & CO. is the latest big pharma firm to exit the inhaled insulin business. The Indianapolis-based company has informed Alkermes, its technology partner for AIR insulin, that it is discontinuing development and ending their supply agreement for the product.

AIR insulin was in broad Phase III trials scheduled for completion this year; Lilly is now halting those studies and transitioning patients to other therapies. Lilly expects to take a write-off ranging from $90 million to $120 million related to the move.

Alkermes and Lilly teamed up to develop the inhaled insulin in 2001. Sidney Taurel, Lilly's chairman and CEO, told C&EN last week that Lilly dropped the program because the chances of gaining approval and then capturing a significant market for the product were poor. "It is not a safety issue," Taurel said. He did note that heightened regulatory uncertainty has surrounded the development of inhaled insulin products.

Indeed, the inhaled insulin space is littered with expensive failures. Pfizer managed to gain approval for its entry, Exubera, only to abandon it after negligible sales in its first year on the market. Pfizer had spent billions of dollars developing and commercializing Exubera, and it wound up incurring a $2.8 billion charge for the debacle. In January, Novo Nordisk said it too was discontinuing development of its inhaled product, AERx insulin.

Although big pharma is walking away from inhaled insulin technology, a handful of small biotechs continue to stay the course. MannKind maintains that its product, TechnoSphere, differs from the abandoned products because it is safer and more effective than injectable insulin, in addition to being more convenient. Generex Biotechnology is moving forward with Phase III studies of its product, Oral-lyn. It announced last week that supplies for a six-month U.S. trial are ready to be shipped to clinical sites. Alkermes has yet to make a statement about its plans for AIR insulin.

The financial markets are less convinced about the future of inhaled insulin. Shares of both MannKind and Generex tumbled after the news of Lilly's withdrawal.

Chemical & Engineering News

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