SAN DIEGO--(BUSINESS WIRE)--
Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) partner
GlaxoSmithKline plc announced today that it has submitted regulatory
applications in the United States and European Union related to
eltrombopag (Promacta®/Revolade®) and its use to increase platelet
counts in patients with chronic hepatitis C virus infection and low
platelets (thrombocytopenia), specifically:
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A supplemental New Drug Application to the US Food and Drug
Administration for Promacta (eltrombopag) as a treatment for
thrombocytopenia in adult patients with chronic hepatitis C infection
to enable the initiation of interferon-based therapy and to optimize
interferon-based therapy.
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A variation to the Marketing Authorization Application to the European
Medicines Agency for Revolade (eltrombopag) as a treatment for
thrombocytopenia in adult patients with chronic hepatitis C infection
to enable the initiation of interferon-based therapy and during
interferon-based therapy.
“We commend GSK for their excellent work and strong commitment to
developing a therapy to enable the sickest patients with Hepatitis C to
have potential new treatment options. This is a very important,
underserved medical market. The recent successful pivotal trials and now
submission of the regulatory applications represent significant
milestones for the ongoing commercialization of Promacta/Revolade and,
importantly, for adult patients with chronic hepatitis C virus infection
and thrombocytopenia. We look forward to the completion of the
regulatory review,” said John Higgins, President and Chief Executive
Officer of Ligand Pharmaceuticals.
About eltrombopag (Promacta®/Revolade®)
Eltrombopag, known by the brand name Promacta in the United States and
Revolade in the European Union and other countries, is currently
approved in 88 countries around the world as a treatment for
thrombocytopenia in patients with chronic immune (idiopathic)
thrombocytopenia. Important Safety Information: Promacta
may cause hepatotoxicity. Other risks for Promacta include: bone marrow
reticulin formation and risk for bone marrow fibrosis,
thrombotic/thromboembolic complications, hematologic malignancies, and
cataracts.
About Ligand Pharmaceuticals
Ligand is a biopharmaceutical company with a business model that is
based upon the concept of developing or acquiring royalty revenue
generating assets and coupling them to a lean corporate cost structure.
Ligand’s goal is to produce a bottom line that supports a sustainably
profitable business. By diversifying the portfolio of assets across
numerous technology types, therapeutic areas, drug targets, and industry
partners, we offer investors an opportunity to invest in the
increasingly complicated and unpredictable pharmaceutical industry. In
comparison to its peers, we believe Ligand has assembled one of the
largest and most diversified asset portfolios in the industry with the
potential to generate revenue in the future. These therapies address the
unmet medical needs of patients for a broad spectrum of diseases
including diabetes, hepatitis, muscle wasting, Alzheimer's disease,
dyslipidemia, anemia, asthma 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,
Merck, Pfizer, Eli Lilly & Company, Baxter International, Bristol-Myers
Squibb, Celgene, Onyx Pharmaceuticals, Lundbeck Inc., The Medicines
Company, Curis, Inc. and Rib-X Pharmaceuticals. Please visit www.captisol.com
for more information on Captisol. For more information on Ligand, please
visit www.ligand.com.
Follow Ligand on Twitter @Ligand_LGND.
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 will not be
subject to sharing obligations with any 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