Biotech Values

[DewDiligence]

GTCB updates ATryn timeline:

[The company now estimates a final EMEA verdict by October. Hopefully, this will put to rest the speculation about the EMEA’s dragging this application out indefinitely.]

http://biz.yahoo.com/bw/050425/255384.html?.v=1

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GTC Biotherapeutics Plans to Respond to EMEA by July 8, 2005

Monday April 25, 8:01 am ET

FRAMINGHAM, Mass.--(BUSINESS WIRE)--April 25, 2005--GTC Biotherapeutics, Inc. ("GTC", Nasdaq:GTCB) plans to respond by July 8, 2005 to the European Medicines Agency's (EMEA) List of Outstanding Issues generated during review of GTC's Market Authorization Application (MAA) for ATryn® , its recombinant form of human antithrombin. This response date follows from meetings between GTC and the EMEA. The EMEA has accepted the response date as a formal extension of the MAA review schedule. Assuming timely filing of the response, GTC estimates that the EMEA could make a determination on the MAA before the end of October.

"We believe we had very constructive and valuable meetings with the agency recently and we are pleased that the EMEA has granted us this extension to complete our response to all outstanding issues," [I very much like the word "all"] noted Geoffrey F. Cox, Ph.D., GTC's Chairman and Chief Executive Officer. "This provides us with the opportunity to bring our MAA to a successful conclusion and we will be continuing to work diligently towards this goal."

Antithrombin is a plasma protein with anticoagulant and anti-inflammatory properties. GTC expresses this protein in the milk of goats that have the human antithrombin gene linked to a milk-protein promoter. This transgenic approach provides the opportunity to produce recombinant forms of proteins, such as antithrombin, that are difficult to express in conventional production methods. Antithrombin is the first of a series of human plasma proteins that GTC is developing as recombinant products. Other recombinant human plasma proteins that GTC is developing include recombinant human albumin and recombinant human alpha-1 antitrypsin.

GTC recently announced that the United States Food and Drug Administration (FDA) has allowed GTC to begin a further clinical study of ATryn® for the hereditary antithrombin deficiency indication. A successful outcome of this study and a historical control comparison is expected to provide the clinical basis for filing a Biologics License Application with the FDA.
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