Biotech Values

[DewDiligence]

Elixir gets the US rights to sell
diabetes treatment from Japan

http://www.boston.com/business

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By Stephen Heuser
March 27, 2006

Elixir Pharmaceuticals Inc., a small Cambridge biotechnology company founded by some of the biggest names in anti-aging research, has signed a deal for the American rights to a diabetes drug made in Japan, the company plans to report today.

The drug, Glufast, is not yet approved in the United States, but has been on the market for two years in Japan and has been tested on more than 1,500 people. Elixir's chief executive estimates the company could apply for Food and Drug Administration approval this year and have the drug on the market by 2008.

If Glufast succeeds, the deal would transform Elixir from a money-losing research start-up into a revenue-generating firm with a sales force and a product on the shelves.

''It's going to be a very different company," said chief executive William Heiden.

The deal, signed Friday, marks a sharp turnabout for a five-year-old company in one of the most exotic fields of medicine: life extension.

Its founders, including Leonard Guarente of the Massachusetts Institute of Technology and Cynthia Kenyon of the University of California, have produced dramatic results extending the lives of microbes and tiny worms in the laboratory.

But after five years and $56 million in venture financing, Elixir hasn't brought any of its own drugs out of the lab and into animal toxicology tests. Aside from Glufast, the closest substance it has to a marketable drug is a growth-hormone booster licensed from Bristol-Myers Squibb that has not been tested in people.

The new diabetes drug, known generically as mitiglinide, is licensed from Kissei Pharmaceutical Co. Ltd. of Japan. It helps diabetics produce enough insulin to prevent dangerous spikes in their blood sugar after meals.

If it wins approval, Heiden said, it will give the company a toehold in the market for treating diabetes, one of the largest and most lucrative segments of the pharmaceutical business. Elixir hopes to spin its life-extension technology into drugs for diabetes and related metabolic problems.

It will face challenges, however. Glufast still faces the hurdles of the US approval process, usually a year or longer. It will compete with two similar drugs already on the market. Made by Novo Nordisk and Novartis, the drugs total about $300 million in sales, Heiden said.

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