Ligand Partner GSK Receives Marketing Authorization from the European Commission for Additional Revolade™ (Eltrombopag) Indication as the First Approved Treatment for Chronic Hepatitis C-Associated Thrombocytopenia
SAN DIEGO--
Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) partner
GlaxoSmithKline plc (LSE:GSK) (NYSE:GSK) announced today that the
European Commission has granted an additional indication for Revolade™
(eltrombopag) as a treatment for low platelet counts (thrombocytopenia)
in adult patients with chronic hepatitis C infection, where the degree
of thrombocytopenia is the main factor preventing the initiation or
limiting the ability to maintain optimal interferon (IFN)-based therapy.1
Thrombocytopenia may prevent the initiation2 and maintenance
of peginterferon (pIFN)-based treatment, thereby reducing a patient’s
chances of achieving a sustained virologic response (SVR)*3 -
the primary goal of hepatitis C treatment.
“We are extremely pleased with the decision of the European Commission,
and eagerly await the launch of Revolade in the European Union for this
indication. This is an important achievement, as otherwise very sick
patients suffering with chronic hepatitis C infection with few
therapeutic options will now have the opportunity to potentially receive
needed treatment,” commented John Higgins, President and Chief Executive
Officer of Ligand. “Ligand commends GSK’s global Revolade and Promacta
team for their commitment to this program and for leading it to
continued regulatory success.”
About Eltrombopag
Eltrombopag, marketed under the brand name Revolade™ in Europe and most
ex-US countries, and Promacta® in the U.S., is an oral thrombopoietin
receptor agonist licensed in over 90 countries around the world as a
treatment for thrombocytopenia in adult patients with chronic immune
(idiopathic) thrombocytopenic purpura (ITP).
Eltrombopag, indicated in adult patients as a once-daily oral therapy,
was approved for chronic hepatitis C-associated thrombocytopenia by the
European Commission on September 23, 2013. Promacta®/Revolade™ is
approved for chronic hepatitis C associated thrombocytopenia in
Argentina, Australia, Bangladesh, Pakistan, Philippines and the US.
About GlaxoSmithKline
GlaxoSmithKline - one of the world’s leading research-based
pharmaceutical and healthcare companies – is committed to improving the
quality of human life by enabling people to do more, feel better and
live longer. For further information please visit www.gsk.com.
About Ligand Pharmaceuticals
Ligand is a biopharmaceutical company that develops and acquires assets
it believes will generate royalty revenues and, under its lean corporate
cost structure, produce sustainable 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, Merck,
Pfizer, Baxter International, Bristol-Myers Squibb, Lundbeck Inc., Eli
Lilly & Co. and Spectrum Pharmaceuticals. Please visit www.captisol.com
for more information on Captisol and www.ligand.com
for more information on Ligand.
Follow Ligand on Twitter @Ligand_LGND.
Forward-Looking Statements
This news release contains certain 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
importance of the approval of additional indications for Revolade
(eltrombopag) or any potential launch or marketing effort associated
therewith. Actual events or results may differ from Ligand’s
expectations. There can be no assurance GlaxoSmithKline will continue
clinical development of eltrombopag, or any additional indications
thereof, that the product will be commercially successful, provide new
options or be successfully marketed; 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. 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’s business can be found in prior press releases available via www.ligand.com
as well as in Ligand’s public periodic filings with the Securities and
Exchange Commission at www.sec.gov.
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.
1 REVOLADE™ Summary of Product Characteristics.
2 Giannini EG et al. Liver Int 2012;32(6):1113-1119.
3 Everson GT et al. Hepatol 2006;44:1675-1684.
* where the hepatitis C virus remains undetectable for six months –
following completion of antiviral therapy
Ligand Pharmaceuticals Incorporated
John Higgins, President and CEO
Jennifer
Capuzelo
(858) 550-7584
jcapuzelo@ligand.com
or
LHA
Don
Markley
(310) 691-7100
dmarkley@lhai.com
Source: Ligand Pharmaceuticals Incorporated
Released September 24, 2013