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Inhaled Insulin

By David Mendosa

Last Update: September 15, 2000

For years our doctors have been telling us that if we take insulin we have to get it by injection. Too bad that we couldn't get it a painless way, but because insulin is a large protein, stomach acids would eat it up before it could go to work.

Meanwhile, a few scientific researchers who wouldn't take "no" for an answer had some other ideas about how insulin could be delivered to the bloodstream. None of these approaches is on the market yet, but a lot of people think that you will be able to use one or more of these systems within the next two years. And all three of the major insulin manufacturers are betting big bucks on one system or another.

…insulin without the ouch.

Just a few days ago the nation's largest insulin manufacturer, Eli Lilly and Company of Indianapolis, Indiana, announced an agreement with Generex Biotechnology Corporation of Toronto, Canada. They will develop a buccal form of insulin.

Buccal? That means the insulin will be absorbed through the inner cheek walls.

This oral insulin spray is currently in Phase 2 testing. Lilly is taking over responsibility for conducting the clinical trials, getting regulatory approval, and marketing it worldwide.

Generex expects its oral insulin spray will not only eliminate the pain, anxiety, and trauma of injected insulin but will also get people with diabetes to take their insulin on schedule. And unlike injected insulin, the Generex oral insulin spray is stable at room temperature and requires no refrigeration.

For several years Lilly has had a rather quiet collaboration on inhaled insulin with Dura Pharmaceuticals Inc., a San Diego company. Dura, in fact, announced in July that it was increasing its commitment to work with Lilly on an inhaled insulin program.

Industry watchers like David Kliff, editor and publisher of "Diabetic Investor" newsletter, however, don't expect the Lilly-Dura agreement to survive Lilly's new agreement with Generex. Kliff calls the new agreement with Generex "big news," because of the easy-to-use design of the Generex RapidMist delivery device, which is similar to devices that people with asthma often use.

Last year Lilly had 48 percent of the worldwide market in volume terms, and Denmark's Novo Nordisk A/S had 44 percent, according to IMS Health, the leading market research firm tracking the global pharmaceutical industry. Aventis S.A. with headquarters in Strasbourg, France, was created in December by the merger of the life sciences activities of Hoechst AG and Rhône-Poulenc S.A. Last year Hoechst had 5.5 percent of the worldwide insulin market, but none in the United States.

In the United States, Lilly has an 86 percent share of the retail pharmacy market compared to Novo's 14 percent. But Lilly's share drops to 78 percent when you factor in insulin use in hospitals and elsewhere where prescriptions aren't required.

But much further along than Lilly and Generex is a three-way partnership among Nektar Therapeutics, formerly Inhale Therapeutic Systems Inc. in San Carlos, California, drug giant Pfizer Inc., and Aventis. Inhale is now conducting Phase 3 human clinical trials of an inhaled form of insulin that is absorbed through the deep lung into the bloodstream. Pfizer has an agreement with Aventis to manufacture, co-develop, and co-market this inhaled insulin.

To produce Inhale's insulin, Aventis and Pfizer in June 1999 began building the world's largest insulin plant in Frankfurt, Germany, at an estimated cost of about $140 million. Pfizer expect construction of the plant to take two years plus a few months for regulatory approval. Depending on FDA approval, its inhaled insulin could be in the lungs of U.S. consumers as early as 2002. That would be a year or two ahead of competitors Lilly and Novo Nordisk.

Novo's partner is Aradigm Corporation of Hayward, California. Its drug delivery system creates aerosols from liquid drug formulations for delivery of inhaled insulin through the lung into the bloodstream. Aradigm's inhaled insulin is nearing completion of Phase 2 trials.

These companies are investing lots of money in inhaled insulin because they expect that many people now using oral medications and others getting regular insulin shots will switch to inhaled insulin. Pfizer and Aventis see a worldwide market potential of more than $3 billion. Kliff thinks that's overoptimistic and would be impressed if the market were $1 billion. Even so, that would mean a lot of us will soon be using insulin without the ouch. 

The American Diabetes Association originally published this article on its Web site as one of my “About the Internet” columns.

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