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Biotech / Medical : MDCO: Medicines Company
MDCO 84.900.0%Jan 6 4:00 PM EST

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To: Mike who wrote (83)5/27/2003 9:49:08 AM
From: tuck  Read Replies (3) of 125
 
This is vague (no timeline given) but good news:

>>PARSIPPANY, N.J.--(BUSINESS WIRE)--May 27, 2003-- The Medicines Company (Nasdaq: MDCO - News) today announced that "Chemilog", the second-generation manufacturing process for the bulk drug substance of Angiomax® (bivalirudin), has been approved by the U.S. Food and Drug Administration (FDA).
The new process involves enhancements to early manufacturing steps to improve the efficiency of synthesizing bivalirudin, the active ingredient of Angiomax. Development of the new process was initiated in 1997 shortly after The Medicines Company acquired rights to Angiomax.

Dave Stack, President and CEO of The Medicines Company stated, "Approval of the Chemilog process once again demonstrates our commitment to aggressive product development. We believe the Chemilog process allows us to scale up our manufacturing efficiently so that we can continue to meet customer demand for Angiomax. The timing of FDA approval allows us to immediately transition to Chemilog manufacturing as planned." <<

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Cheers, Tuck
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