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DewDiligence

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Re: DewDiligence post# 5805

Monday, 12/20/2004 11:11:30 AM

Monday, December 20, 2004 11:11:30 AM

Post# of 257269
GTCB update:

[This looks like two out of three: the ATryn answers were submitted to the EMEA, the U.S. IND amendment submission to the FDA occurs this week, but there is no ATryn partnership deal for the time being. I’m disappointed by the further delay in inking an ATryn partnership, but not especially surprised (#msg-4857141).

Submitting the ATryn answers to the EMEA restarts the review clock; hence the statement in the PR that an outcome is expected by the end of April. The ATryn launch remains on track for mid-2005 pending approval by the EU Commission.]

http://biz.yahoo.com/bw/041220/200246_1.html

>>
GTC Biotherapeutics Provides ATryn Program Update

Monday December 20, 10:53 am ET

FRAMINGHAM, Mass.--(BUSINESS WIRE)--Dec. 20, 2004--GTC Biotherapeutics, Inc. ("GTC", Nasdaq: GTCB) announced that it has submitted its responses to the Consolidated List of Questions generated by the European Medicines Agency (EMEA) as part of the review of a Marketing Authorization Application (MAA) for ATryn®, GTC's recombinant form of human antithrombin. The MAA covers the use of ATryn® in the prophylactic treatment of patients with hereditary antithrombin deficiency (HD) during high-risk situations such as surgery and childbirth. GTC expects the EMEA to respond with additional questions, or provide an opinion on the MAA, by the end of April. Subject to approval of the MAA, GTC is planning for a European market launch of ATryn® in mid-2005.

GTC is also submitting an amendment to its Investigational New Drug (IND) application this week to initiate a clinical study which may be used as a basis for approval of ATryn® in the HD indication in the United States. GTC expects to begin the study when the FDA has completed its review of this submission, which is anticipated in early 2005. GTC is taking advantage of these advances in its regulatory process to continue its partnering negotiations for ATryn® into the first half of 2005. As a result, GTC now expects its 2004 year-end net cash balance to be approximately $22 million.

"We believe the responses to the EMEA provide a solid foundation for completion of the regulatory review process in Europe and a stronger basis to realize value from the ATryn® program," stated Geoffrey F. Cox, Ph.D., GTC's Chairman of the Board and Chief Executive Officer.

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.
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