Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) announced
today that the U.S. Food and Drug Administration (FDA) has granted
accelerated approval of GlaxoSmithKline’s (GSK) PROMACTA® (eltrombopag)
for the treatment of thrombocytopenia in patients with chronic immune
(idiopathic) thrombocytopenic purpura (ITP) who have had an insufficient
response to corticosteroids, immunoglobulins or splenectomy. PROMACTA is
the first oral thrombopoietin (TPO) receptor agonist therapy for the
treatment of adult patients with chronic ITP.
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 has been shown in
pre-clinical research and clinical trials to stimulate the proliferation
and differentiation of cells in the bone marrow to produce platelets.
"Today marks an important milestone for Ligand as this is the first NDA
approval stemming from one of our collaborator programs,” said John L.
Higgins, President and Chief Executive Officer of Ligand
Pharmaceuticals. "We are very pleased with the FDA approval of PROMACTA
as it validates Ligand’s success contributing to the discovery of novel,
innovative therapies, and demonstrates our ability to create valuable
financial assets and potential cash flows by entering into
collaborations with pharmaceutical companies. I commend GSK for its
dedication and commitment to creating a new treatment option for this
potentially life-threatening disease.”
As a result of the FDA’s approval of PROMACTA, Ligand will be entitled
to receive a $2 million milestone payment from GSK. In addition, Ligand
will earn tiered royalties in the range of 5%-10% on annual net sales of
PROMACTA.
In addition to ITP, GSK reported positive Phase II data in patients with
thrombocytopenia associated with hepatitis C and initiated two Phase III
trials in patients with hepatitis C in the fourth quarter of 2007. A
Phase II study in patients with chemotherapy-induced thrombocytopenia
has been completed, a Phase III study is ongoing in chronic liver
disease and a Phase I study is ongoing in patients with sarcoma
receiving the adriamycin and ifosfamide regimen. GSK also expects an MAA
submission for the long-term treatment of ITP by year-end.
About Ligand Pharmaceuticals
Ligand discovers and develops new drugs that address critical unmet
medical needs of patients with thrombocytopenia, hepatitis C,
hormone-related diseases, osteoporosis, inflammatory diseases and
anemia. Ligand's proprietary drug discovery and development programs are
based on its leadership position in gene transcription technology.
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 the
timing of PROMACTA’s commercial availability, and the ability of the
company to create valuable financial assets and cash flows from its
research and development activities. Actual events or results may differ
from our expectations. In particular there can be no assurance that
PROMACTA will be commercially successful. In addition, Ligand’s partners
may change their plans or timetables regarding Ligand’s other partnered
products and expected regulatory actions (e.g., filings, approvals,
etc.) may be delayed or may not occur. Any payments expected related to
PROMACTA may not be received by Ligand due to third party intellectual
property or contract restrictions and any amounts received by Ligand may
be subject to third party claims. 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.