GTC Biotherapeutics, Inc. ("GTC", Nasdaq: GTCB) has completed its
submission of the final portion of the Biologics License Application, or
BLA, for ATryn® in
the United States. The final portion of the BLA submission includes all
of the clinical safety and efficacy data generated from studies of ATryn®,
including the pivotal study supporting product licensure. ATryn®
is GTC’s recombinant form of human
antithrombin, a plasma protein with anticoagulant and anti-inflammatory
properties. The BLA requests market authorization for the use of ATryn®
in the prophylactic treatment of deep vein thrombosis and other
thromboembolisms in patients with hereditary antithrombin deficiency who
are undergoing high risk surgical and childbirth procedures. There are
no other recombinant forms of antithrombin available to treat this
patient population.
GTC has requested Priority Review. Priority Review is a procedure the
U.S. Food and Drug Administration, or FDA, reserves for products that
are intended to treat serious and/or potentially life threatening events
and have the potential to fulfill an unmet medical need. ATryn®
has already been granted Orphan Drug designation, as well as Fast Track
status by the FDA. Assuming that Priority Review is granted, GTC
anticipates the FDA reaching a decision on the BLA filing in the first
quarter of 2009. A definitive agreement has been signed with OVATION
Pharmaceuticals, Inc. for commercialization and development rights in
the U.S.
ATryn® has been
approved for use in a similar indication in the European Union. LEO
Pharma A/S is marketing ATryn®
in Europe and is conducting further clinical development.
About GTC Biotherapeutics
GTC Biotherapeutics develops, supplies, and commercializes therapeutic
proteins produced through transgenic animal technology. In addition to
ATryn®, GTC is
developing a portfolio of recombinant human plasma proteins with known
therapeutic properties. These proteins include recombinant forms of
human coagulation factors VIIa and IX, which are used for the treatment
of hemophilia, and alpha-1 antitrypsin. GTC also has a monoclonal
antibody portfolio that includes a monoclonal antibody to CD20 and a
monoclonal antibody to CD137. GTC’s
intellectual property includes a patent in the United States through
2021 for the production of any therapeutic protein in the milk of any
transgenic mammal. GTC’s transgenic
production platform is particularly well suited to enabling cost
effective development of proteins that are difficult to express in
traditional recombinant production systems as well as proteins that are
required in large volumes. Additional information is available on the
GTC web site, http://www.gtc-bio.com.
This press release contains forward-looking statements as defined in the
Private Securities Litigation Reform Act of 1995, including without
limitation statements regarding prospects for Priority Review of the BLA
for ATryn® and the
timing for FDA review and approval of the BLA. Such forward-looking
statements are subject to a number of risks, uncertainties and other
factors that could cause actual results to differ materially from future
results expressed or implied by such statements. Factors that may cause
such differences include, but are not limited to, the risks and
uncertainties discussed in GTC's most recent Annual Report on Form 10-K
and its other periodic reports filed with the Securities and Exchange
Commission, including the uncertainties associated with conducting
clinical studies, and the risks and uncertainties associated with
dependence upon the actions of collaboration partners and regulatory
agencies. GTC cautions investors not to place undue reliance on the
forward-looking statements contained in this release. These statements
speak only as of the date of this document, and GTC undertakes no
obligation to update or revise the statements, except as may be required
by law.
GTC Biotherapeutics, Inc.
Thomas E. Newberry, 508-370-5374
Vice
President, Corporate Communications
and Government Relations
tom.newberry@gtc-bio.com
