GTC Receives $2 Million in Milestone Payments
The US Food and Drug Administration, or FDA, has accepted for review GTC
Biotherapeutics, Inc.’s ("GTC", Nasdaq: GTCB)
Biologics License Application, or BLA, for ATryn®.
FDA’s Blood Products Advisory Committee
intends to review the BLA for ATryn®
during a meeting that is being planned for January 2009. Based on the
achievement of these milestones, GTC has received $2 million in
additional milestone payments from OVATION Pharmaceuticals, Inc.
As previously announced, ATryn®
has been designated an Orphan Drug and FDA has determined that the
product fulfills the criteria for Fast Track status. The ATryn®
BLA will also receive Priority Review. Priority Review is granted to
only to those products that, if approved, would provide a significant
improvement in the safety or effectiveness of the treatment, diagnosis
or prevention of a serious or life-threatening disease. Under Priority
Review, the target date for FDA action on the BLA is February 7, 2009.
This action date was affirmed by the FDA following preliminary review of
the BLA performed in accepting the BLA.
ATryn® is GTC’s
recombinant form of human antithrombin, a plasma protein with
anticoagulant and anti-inflammatory properties. The company seeks
regulatory approval of ATryn®
in the United States for 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 rare patient population. GTC has
licensed ATryn® to
OVATION Pharmaceuticals, Inc. to develop and market it in the United
States.
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, VIII, 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 the timing of the Advisory Committee
meeting and target action dates for the ATryn®
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 dependence upon the actions of 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
