Ligand Partner GlaxoSmithKline Receives Positive CHMP Opinion for REVOLADE™
in Thrombocytopenia Associated with Chronic Hepatitis C Infection
SAN DIEGO -- July 26, 2013
Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) partner GlaxoSmithKline
(NYSE: GSK) announced that today, the European Medicines Agency's Committee
for Medicinal Products for Human Use (CHMP) issued a positive opinion
recommending marketing authorization for GSK’s 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-based therapy.
“We are very pleased with this latest development as we view Promacta/REVOLADE
as an important medicine in this indication, even as the clinical landscape
evolves with new potential hepatitis C therapies on the horizon. GSK recently
reported increased sales for Promacta in the US, citing growth due to the use
in the hepatitis C indication," commented John Higgins, President and Chief
Executive Officer of Ligand. “We congratulate our partners at GSK on this
achievement and commend GSK’s global Promacta/REVOLADE team on its continued
commitment to bring this medicine to patients in need.”
The CHMP opinion is based on review of safety and efficacy data for
eltrombopag, including two randomized, double-blind, placebo controlled,
multi-center Phase 3 studies of more than 1,500 patients.
A CHMP positive opinion is one of the final steps before marketing
authorization is granted by the European Commission, but does not always
result in marketing authorization.
More about thrombocytopenia related to chronic Hepatitis C Infection
Hepatitis C virus infection (HCV) is the most common blood borne viral
infection, affecting up to 170 million people world-wide. Chronic HCV
infection is associated with chronic liver disease which can lead to a number
of blood-related disorders including low platelet count (thrombocytopenia).
Treatment with pegylated interferon and ribavirin is the current standard of
care for patients with HCV, however both the European Association for the
Study of the Liver guidelines and the American Association for the Study of
Liver Diseases report the presence of thrombocytopenia among the relative
contraindications to antiviral therapy ^1,2.
More about REVOLADE™ (eltrombopag)
In the European Union (EU), eltrombopag is currently approved as a treatment
for thrombocytopenia in patients with chronic immune (idiopathic)
thrombocytopenia. In the US, eltrombopag is marketed under the trade name
PROMACTA® and is currently approved as a treatment for patients with chronic
immune (idiopathic) thrombocytopenia who have had insufficient response to
corticosteroids, immunoglobulins, or splenectomy and as a treatment for
thrombocytopenia in patients with chronic hepatitis C infection to allow the
initiation and maintenance of interferon-based therapy.
The most important serious adverse reactions identified in the ITP or HCV
trials were hepatotoxicity, including hepatic decompensation events and
The most common adverse reactions (experienced by at least 10 % of patients)
of any grade in the ITP or HCV trials included; headache, anemia, decreased
appetite, insomnia, cough, nausea, diarrhea, alopecia, pruritus, myalgia,
pyrexia, fatigue, influenza like illness, asthenia, chills and peripheral
oedema. For the full EU Summary of Product Characteristics for Revolade™ and
full US Prescribing Information, including BOXED WARNING and Medication Guide
for Promacta® please visit http://www.gsk.com/products/index.htm.
Important safety information for Revolade™
There is an increased risk for adverse reactions, including potentially fatal
hepatic decompensation and thromboembolic events, in thrombocytopenic HCV
patients with advanced chronic liver disease, as defined by low albumin levels
≤ 35 g/L or MELD score ≥ 10, when treated with eltrombopag in combination with
interferon based therapy. Treatment with eltrombopag in these patients should
be initiated only by physicians experienced in the management of advanced HCV,
and only when the risks of thrombocytopenia or withholding antiviral therapy
necessitate intervention. If treatment is considered clinically indicated,
close monitoring of these patients is required.
Risk of hepatotoxicity
Eltrombopag administration can cause abnormal liver function. Liver enzyme
elevations have been reported in the ITP and HCV populations. Most patients
being treated with eltrombopag in combination with peginterferon/ribavirin
will experience indirect hyperbilirubinaemia. Hepatic enzymes should be
measured prior to the initiation of eltrombopag therapy. Discontinue therapy
if liver enzymes do not stabilize or are accompanied by worsening liver
Hepatic decompensation (use with interferon)
Chronic HCV patients with cirrhosis may be at risk of hepatic decompensation
when receiving alpha-interferon therapy. Hepatic decompensation was reported
in controlled clinical studies in thrombocytopenic patients with HCV treated
with eltrombopag in combination with interferon-based antiviral therapy.
Patients should be monitored closely for signs and symptoms suggestive of
hepatic decompensation, in particular, ascites, hepatic encephalopathy and
variceal hemorrhage. Eltrombopag therapy should be terminated if antiviral
therapy is discontinued for hepatic decompensation. Patients with poor liver
function at baseline [albumin ≤35g/L or MELD score ≥ 10] should be closely
Venous and arterial thrombotic/thromboembolic complications have occurred with
eltrombopag therapy. Portal vein thrombosis was the most common thromboembolic
event reported in controlled clinical studies in thrombocytopenic patients
with HCV. Patients with poor liver function at baseline are at increased risk
of thromboembolic events. Patients should be monitored closely for signs and
symptoms suggestive of thromboembolic events.
Combination with direct acting antiviral agents
Safety and efficacy have not been established in combination with direct
acting antiviral agents approved for treatment of chronic hepatitis C
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, Celgene, Lundbeck
Inc., Eli Lilly & Co., Spectrum Pharmaceuticals and The Medicines Company.
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.
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 include statements regarding clinical development of REVOLADE,
market size and possibility of commercial success, efficacy, potency, and
competitiveness. Actual events or results may differ from our expectations.
For example, there can be no assurance that REVOLADE will progress through
clinical development or receive required regulatory approvals within the
expected timelines or at all, that further clinical trials will confirm any
safety or other characteristics or profile, that there will be a market of any
size for REVOLADE or that REVOLADE will be beneficial to patients or
successfully marketed. The failure to meet expectations with respect to any of
the foregoing matters may have a negative effect on 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 European Association for the Study of the Liver. EASL Clinical Practice
Guidelines: management of hepatitis C virus infection. J Hepatol 2011; 55:
^2 Ghany MG, Strader DB, Thomas DL, et al. Diagnosis, management, and
treatment of hepatitis C: an update. Hepatology 2009; 49: 1335–74.
Ligand Pharmaceuticals Incorporated
John Higgins, President and CEO
Jennifer Capuzelo, Investor Relations
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