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Pharmaceuticals

Buccal Spray Insulin

April 28, 2008 | APPEARED IN VOLUME 86, ISSUE 17

The article about Eli Lilly & Co. terminating its development of AIR insulin while the drug was in Phase III clinical trials (C&EN, March 17, page 9) states: “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.”

I want to point out an error in the article. Generex Biotechnology is not developing an inhalable insulin. They are developing a buccal insulin spray. No insulin is deposited into the lungs by the Oral-lyn Rapidmist delivery system. The absorption enhancers coat the insulin and form micelles that are too large to enter the pulmonary tract, and the absorption takes place in the inner cheek wall. All excess insulin is destroyed in the stomach. A recent Phase II study in patients with type 1 diabetes ended after a 99-day period with Oral-lyn illustrating a superior effect versus Lilly’s Humalin as measured by the patients’ A1C levels.

Ironically, Generex was once partnered with Lilly for the development of Oral-lyn. Lilly was already partnered with Alkermes for their AIR insulin inhalable, and Lilly chose the wrong route. Oral-lyn is approved in Ecuador and in India, which is home to one-third of the world’s diabetics. I have followed Generex for some time and am rooting for this small biotech to accomplish what big pharma could not.

Richard Steffens
Asbury Park, N.J.

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