GTC Biotherapeutics (fka GTCB)

[DewDiligence]

Another story on ART-123 for DIC:

http://masshightech.bizjournals.com/masshightech/stories/2008/03/10/newscolumn2.html

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Artisan’s Partner Wins Japanese OK

10-Mar-2008

On the therapeutics front, Waltham (MA) biotech Artisan Pharma Inc. sees new opportunities with the market acceptance of its anti-clotting treatment in Japan -- even though Artisan wasn't the company to garner the approval.

Japanese drug firm Asahi Kasei Pharma Corp., which has licensed the protein drug to Artisan for outside of major Asian markets, won market approval of the drug for sales in Japan in January, according to Artisan. And while the other firm's big win lends credibility to the treatment in the United States, where Artisan seeks approval of the drug, CEO Jeffrey Wager said the clearance may bring his company some early revenue.

Wager said there are countries considered "secondary" markets, such as Israel, that accept drug approval from Japan without additional studies. Though Artisan won't seek such approvals alone, he said, it would be happy to sublicense the drug to companies in exchange for non-dilutive investments and cash. He declined to reveal details on his discussions with potential sublicensees, however.

For now, Artisan is focusing its resources on a Phase 2 clinical trial involving 800 patients with a condition known as disseminated intravascular coagulation, which describes the rampant clotting that occurs in people with an inflammatory disease called sepsis.

In fact, Wager said, the biotech plans to add four workers to its lean staff of 16 people in the coming months to help support its large clinical trial, which he expects to wrap up in the first half of 2009. He had no estimate on when the firm would get final U.S. approval of the treatment.
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