Jan 9 2010
GTC Biotherapeutics, Inc. (“GTC”, NASDAQ: GTCB) announced that LFB
Biotechnologies, a wholly owned subsidiary of LFB S.A. (Laboratoire
Français du Fractionnement et des Biotechnologies S.A., Les Ulis,
France) and a strategic shareholder in GTC, has converted the
convertible preferred stock it previously purchased in November 2009
under the terms described in the financing agreements approved by GTC
shareholders in July 2009 into a total of 5.3 million shares of common
stock. This completes the conversion into common shares of all
convertible preferred stock acquired by LFB in 2009.
Portfolio Update
GTC plans to advance its recombinant human factor VIIa program into a
Phase I clinical study in the first half of 2010 and its
alpha-fetoprotein program into a Phase II study in Myasthenia Gravis in
the second half of 2010 after securing a partner for that program.
Building upon the 2009 FDA approval of ATryn®, GTC’s
recombinant human antithrombin, GTC is collaborating with its US
commercialization partner, Lundbeck Inc., to develop a protocol for a
pivotal study of patients with acquired antithrombin deficiencies in
cardiac surgery. GTC aims to initiate this clinical trial in the second
half of 2010.
The proposed health care reform legislation in the US Congress includes
provisions enabling the review and regulatory approval of follow-on
biologics. GTC continues to develop its portfolio of monoclonal
antibodies for use as follow-on biologics. The portfolio includes
antibodies targeting CD20, HER2, EGFR and TNF, which currently have a
market size in excess of $16 billion. Production animals for these
programs are in development, and are already established for CD20 and
HER2 monoclonal antibodies. In 2010, GTC plans to characterize each of
these transgenically-derived proteins as they become available and to
initiate non-clinical studies. GTC plans to enter into partnerships to
support the clinical development and commercialization of these
programs. Our objective is to commence clinical trials on the CD20 and
HER2 antibodies in 2011 and 2012, respectively.