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http://www.nytimes.com/2002/09/24/health/policy/24FLU.html

Drugmakers Trying to Retire the Needle

By THE ASSOCIATED PRESS


SAN FRANCISCO — Everybody hates needles.

Millions of diabetics aggravate their disease by skipping insulin injections. Countless Americans would rather risk catching influenza than getting inoculated against the virus each year.

Seeing financial promise in the fear of needles, several biotechnology companies are scrambling to develop alternative delivery systems, including inhaled versions of injectable drugs.

MedImmune Inc. of Gaithersburg, Md., is hoping the Food and Drug Administration will approve its nasal spray influenza vaccine in time for the flu season.

Many doctors eagerly await the nasal spray, saying it would encourage more immunization. Each year, about 70 million people receive flu shots, yet influenza still kills 20,000 Americans and sends about 100,000 to hospitals each year, the Centers for Disease Control and Prevention reports.

Children are the primary transmitters of flu, often infecting their parents and grandparents and others who provide care, yet they rarely receive shots.

In the San Francisco area, Inhale Therapeutics Systems Inc. and Aradigm Corporation, along with their pharmaceutical partners, are racing to have their versions of inhaled insulin approved by the government.

If one or both succeed, analysts and biotech executives say, drugmakers will try to make other injectable drugs possible to inhale, including those for cancer.

Such a breakthrough would make patients' lives easier and could be a boon for the biotechnology industry. Most biotechnology drugs on the market or near approval must be injected. The industry devoted most of its resources to developing novel therapies and paid little attention to drug delivery.

Most biotechnology drugs involve bigger molecules than traditional medicines, so they require injections.

"This has kept in check a lot of growth in the biotechnology industry," said Robert Chess, chairman of Inhale Therapeutics in San Carlos, Calif. "There aren't very many big-selling drugs that are injectable."

Insulin is an exception. About 17 million Americans have diabetes, though up to 6 million of the cases are not diagnosed. Not all diabetics require insulin, but sales of the drug last year totaled $3.6 billion. Needle-free insulin could double annual sales by 2006, some analysts predict.

Most of the growth would come from the estimated four million diabetics who do not inject insulin because of aversions to needles, Mr. Chess said.

Cases of diabetes are increasing faster than the population, with almost 800,000 new cases diagnosed each year in the United States.

Inhale Therapeutics, Aradigm and several other companies developing products to be inhaled say they can capture a big share of the insulin market while encouraging more diabetics to stay with their insulin regimens.

"If proven safe, they will be very broadly adopted," said Ian Sanderson, an analyst at S. G. Cowen Securities Inc. "A lot of diabetics are going to adopt this very quickly."

Still, convincing the Food and Drug Administration that inhaled insulin is safe and effective has proved tougher than expected.

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