Ligand Partner GlaxoSmithKline Receives FDA Acceptance and Granted Priority Review for PROMACTA(R) NDA
SAN DIEGO--
Ligand Pharmaceuticals Incorporated (NASDAQ:LGND) today announced
that the U.S. Food and Drug Administration (FDA) has accepted for
filing and review GlaxoSmithKline's new drug application (NDA) and has
granted a priority review status for PROMACTA(R) (eltrombopag) for
treatment of chronic short-term idiopathic thrombocytopenic purpura
(ITP). Priority review is granted by the FDA for a treatment that
addresses significant unmet medical needs or has the potential to
provide a significant improvement compared to marketed products, and
results in a review period of six months from the date of NDA
submission.
If approved, PROMACTA would be the first oral thrombopoietin
receptor agonist therapy for the short-term treatment of previously
treated patients with chronic ITP to increase platelet counts and
reduce or prevent bleeding. Chronic ITP is a disorder marked by
increased platelet destruction and/or inadequate platelet production
in the blood, which causes an increased risk of bruising and bleeding.
PROMACTA is an investigational, once-daily oral treatment that induces
the proliferation and differentiation of cells in the bone marrow to
produce platelets.
"Priority FDA review for PROMACTA clearly reflects the need for an
effective therapy for patients suffering from ITP," said John L.
Higgins, President and Chief Executive Officer of Ligand
Pharmaceuticals. "We are extremely pleased and commend
GlaxoSmithKline's team for their progress and dedication in taking
PROMACTA a step closer toward commercialization. This is a critical
milestone and we look forward to the completion of the FDA's review."
Ligand and GlaxoSmithKline Collaboration
The GSK-Ligand collaboration began in 1997 to utilize Ligand's
expertise and technology to discover small-molecule drugs to control
hematopoieses and treat patients with cancer, anemia or platelet
deficiencies. The research phase of the collaboration ended in 2001.
GSK is responsible for the registration and worldwide marketing of
PROMACTA.
About Ligand Pharmaceuticals
Ligand discovers and develops new drugs that address critical
unmet medical needs of patients in the areas of thrombocytopenia,
cancer, hepatitis C, hormone-related diseases, osteoporosis and
inflammatory diseases. Ligand's proprietary drug discovery and
development programs are based on its leadership position in gene
transcription technology, primarily related to intracellular
receptors.
Forward-Looking Statements
This news release contains forward-looking statements by Ligand
that involve risks and uncertainties and reflect Ligand's judgment as
of the date of this release. These statements include those related to
future action by the FDA for the recently submitted NDA; the promise
of PROMACTA (eltrombopag) future regulatory approvals; increases in
shareholder value; and future milestone and royalty payments. Actual
events or results may differ from our expectations. There can be no
assurance GlaxoSmithKline, or any of our other partners will continue
clinical development of any compound(s); that clinical development
will be successful; that future clinical trial data will be favorable
or that such trials will confirm any improvements over other products
or lack of negative impacts; that drugs will receive required
regulatory approvals or that they will be commercially successful
therapies, provide new options or be successfully marketed; that our
partner portfolio will continue to mature, that our business will
continue to grow or that shareholder value will increase, that the FDA
will accept any filing, that any future milestone or royalty payments
will be received, or that if any future milestones or royalties are
received that they won't be subject to sharing obligations with
Rockefeller University and/or any other third party. Our stock price
could be harmed if any of these events or trends fails to occur, is
delayed or otherwise differs from expectations. Additional information
concerning these and other risk factors affecting Ligand's business
can be found on the company's prior press releases as well as in
public periodic filings with the Securities and Exchange Commission,
available via www.ligand.com. Ligand disclaims any intent or
obligation to update these forward-looking statements beyond the date
of this release. This caution is made under the safe harbor provisions
of the Private Securities Litigation Reform Act of 1995.
Source: Ligand Pharmaceuticals Incorporated
Released March 3, 2008