Biotech Values

[DewDiligence]

GTCB submits answers to EMEA’s questions:

[The EMEA had imposed a deadline of July 8 for the submission. Supposedly, work expands to fill the time allotted for its completion (C. Northcote Parkinson’s Law), but evidently this did not *fully* apply in this case.

Jesting aside, it’s nice that this phase of the ATryn marketing application is completed. The ball is now in the EMEA’s court and investors can expect a decision by the Agency in October, or conceivably sooner. The end-of-October estimate for an EMEA opinion is based on the standard timeline for the Agency’s reviews, taking into account that most of Europe goes on vacation for part of August.]

http://biz.yahoo.com/bw/050706/65590.html?.v=1

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GTC Biotherapeutics Files Response to EMEA List of Outstanding Issues

Wednesday July 6, 11:34 am ET

FRAMINGHAM, Mass.--(BUSINESS WIRE)--July 6, 2005--GTC Biotherapeutics, Inc. ("GTC", Nasdaq: GTCB) has filed its response 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. GTC estimates that the EMEA will make a determination on the MAA before the end of October.

"With the filing of our response, we look forward to continuing to work with the EMEA to bring our submission to a positive conclusion," noted Geoffrey F. Cox, Ph.D., GTC's Chairman and Chief Executive Officer. "Approval will be a major milestone in the transition of GTC into a commercial products company."

Antithrombin is a plasma protein with anticoagulant and anti-inflammatory properties. GTC has developed goats that have the human antithrombin gene linked to a milk-protein promoter so that they express the antithrombin protein in their milk. 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 alpha-1 antitrypsin and recombinant human albumin.

GTC also recently began the recruitment process for a pivotal clinical study of ATryn® for the hereditary antithrombin deficiency indication as allowed by the United States Food and Drug Administration (FDA). This study builds upon the clinical data that was submitted in the MAA. A successful outcome of this study and a historical control comparison is expected to provide the clinical basis for filing a Biologics License Application (BLA) with the FDA.
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