GTC Biotherapeutics, Inc. ("GTC", Nasdaq: GTCB) announced the closing of
its previously announced collaboration agreement with OVATION
Pharmaceuticals, Inc. (“OVATION”)
to develop and market ATryn®
in the United States. ATryn®
is GTC’s recombinant form of human
antithrombin, a plasma protein with anticoagulant and anti-inflammatory
properties. The agreement includes $257 million in potential payments to
GTC for meeting clinical, regulatory, and sales milestones, including a
$3 million payment from OVATION to GTC at the closing, $2 million in
payments anticipated for regulatory milestones in 2008, and up to an
additional $4 million in milestone payments through a successful
approval of ATryn® in
2009 for the hereditary antithrombin deficiency, or HD, indication.
ATryn® has already
been granted both Orphan Drug designation and Fast Track status for HD
by the U.S. Food and Drug Administration. GTC has requested Priority
Review as part of the Biologics License Application, or BLA, submitted
for licensure of ATryn®
in preventing deep vein thrombosis in HD patients undergoing high risk
surgical procedures and in childbirth. Assuming GTC’s
request for Priority Review is granted, a decision on market approval by
the FDA could be reached in the first quarter of 2009.
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® in the
U.S., the likely timing for completion of the BLA filing and 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
