|[February 28, 2014]
Ligand Partner GlaxoSmithKline Submits U.S. Regulatory Application for Promacta® (eltrombopag) for Severe Aplastic Anaemia
SAN DIEGO --(Business Wire)--
Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) partner
GlaxoSmithKline plc (LSE:GSK) announced today the submission of a
supplemental New Drug Application (sNDA) to the U.S. Food and Drug
Administration (FDA) for Promacta® (eltrombopag) for the
treatment of cytopenias (a reduction in blood cells) in patients with
severe aplastic anaemia (SAA) who have had an insufficient response to
immunosuppressive therapy (IST).
SAA is a rare disorder in which the bone marrow fails to make enough new
blood cells. There are no approved therapies available for SAA patients
unresponsive to IST. Of those patients unresponsive to initial IST,
approximately 40% die from infection or bleeding within 5 years of their
On February 3, 2014, GSK announced that the FDA granted Breakthrough
Therapy designation for Promacta in SAA.
The sNDA application is based on the results from an open-label, Phase
II National Institutes of Health (NIH) study of eltrombopag in 43
heavily pre-treated SAA patients with an insufficient response to IST.
Eltrombopag-marketed as Promacta® in the U.S. and as
Revolade™ in Europe and other countries across the world-is not approved
or licensed anywhere in the world for use in severe aplastic anaemia.
Eltrombopag is approved in 100 countries worldwide for the treatment of
thrombocytopenia in patients with chronic immune (idiopathic)
thrombocytopenic purpura (ITP) and in 43 countries worldwide for the
treatment of for the treatment of thrombocytopenia (low blood platelet
counts) in patients with chronic hepatitis C to allow them to initiate
and maintain interferon-based therapy.
For full Promacta U.S. Prescribing Information and Medication Guide and
EU Patient Information Leaflet or Summary of Product Characteristics
(SPC) for Revolade™ (eltrombopag) please visit http://www.gsk.com/products.html.
About Ligand Pharmaceuticals
Ligand is a biopharmaceutical company focused on maintaining and growing
its large portfolio of revenue generating assets through licensing and
acquisition with the goal to optimize and sustain cash-flow and
profitability. Ligand has a diverse asset portfolio addressing the unmet
medical needs of patients for a broad spectrum of diseases including
thrombocytopenia, multiple myeloma, diabetes, hepatitis, muscle wasting,
dyslipidemia, anemia and osteoporosis. Ligand's Captisol® platform
technology is a patent-protected, chemically modified cyclodextrin with
a structure designed to optimize the solubility and stability of drugs.
Ligand has established multiple alliances with the world's leading
pharmaceutical companies including GlaxoSmithKline, Onyx Pharmaceuticals
(a subsidiary of Amgen Inc.), Merck, Pfizer, Baxter International,
Lundbeck Inc., Eli Lilly & Co. and Spectrum (News - Alert) Pharmaceuticals. Please
for more information on Captisol or www.ligand.com
for more information on Ligand.
Follow Ligand on Twitter (News - Alert) @Ligand_LGND.
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 forward-looking statements include comments
regarding eltrombopag and other drug candidates, data analysis and
evaluation of eltrombopag, utility or potential benefits to patients,
the potential commercial market for eltrombopag and plans for continued
development and further studies of eltrombopag. Actual events or results
may differ from Ligand's expectations. For example, there can be no
assurance that other trials or evaluations of eltrombopag or other
product candidates will be favorable or that they will confirm results
of previous studies, that data evaluation will be completed or
demonstrate any hypothesis or endpoint, that eltrombopag or other
product candidates will provide utility or benefits to certain patients,
that any presentations will be favorably received, that eltrombopag or
other product candidates will be useful, that marketing applications
will be filed or, if filed, approved, or that clinical or commercial
development of these product candidates will be initiated, completed or
successful or that our rights to eltrombopag and other related product
candidates will not be successfully challenged. The failure to meet
expectations with respect to any of the foregoing matters may reduce
Ligand's stock price. Additional information concerning these and other
risk factors affecting Ligand can be found in prior press releases
available at www.ligand.com
as well as in public periodic filings with the Securities and Exchange
Commission, available at www.sec.gov.
Ligand disclaims any intent or obligation to update these
forward-looking statements beyond the date of this press release. This
caution is made under the safe harbor provisions of the Private
Securities Litigation Reform Act of 1995.
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