Ligand Partner GlaxoSmithKline Receives FDA Extended Priority Review for PROMACTA(R) NDA
SAN DIEGO--
Ligand Pharmaceuticals Incorporated (NASDAQ:LGND) announced today
that the U.S. Food and Drug Administration has extended the priority
review period for GlaxoSmithKline's (GSK) New Drug Application (NDA)
for PROMACTA(R) (eltrombopag) for the short-term treatment of chronic
idiopathic thrombocytopenic purpura (ITP). The Prescription Drug User
Fee action date has been extended to September 19, 2008.
GSK submitted an NDA for PROMACTA in December 2007. In March 2008,
the FDA granted the drug Priority Review. In May 2008, orphan drug
designation was also granted for this indication. On May 30, 2008, the
FDA's Oncology Drugs Advisory Committee (ODAC) panel unanimously voted
(16-0) that eltrombopag demonstrated a favorable risk-benefit profile
for the short-term treatment of patients with chronic ITP.
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.
About Ligand Pharmaceuticals
Ligand discovers and develops new drugs that address critical
unmet medical needs of patients in the areas of thrombocytopenia,
hepatitis C, cancer, 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 June 20, 2008