Ligand Announces Approval for Revolade(R) in Japan
SAN DIEGO-- Ligand Pharmaceuticals Incorporated (NASDAQ:LGND) today announced its partner GlaxoSmithKline (NYSE:GSK) was granted approval from the Japanese Ministry of Health, Labour and Welfare for Revolade(R) (eltrombopag) for the treatment of the blood disorder, chronic idiopathic thrombocytopenic purpura (ITP). Eltrombopag is indicated for adult chronic ITP splenectomized patients who have not responded (are refractory) to other treatments, such as corticosteroids and immunoglobulins. Eltrombopag may also be considered as second-line treatment for adult non-splenectomized patients where surgery is contraindicated.
Revolade is the world's first oral treatment that stimulates the production of blood platelets, which are essential to normal clotting. ITP patients experience bruising and bleeding and, in some cases, serious hemorrhages, which can be fatal. ITP may also affect a patient's quality of life, as it is often associated with fatigue and depression and a fear of bleeding may limit everyday activities.
Eltrombopag was given accelerated approval by the US Food and Drug Administration (FDA) under the trade name Promacta(R) in November 2008, for the treatment of chronic ITP in adults who have had an insufficient response to corticosteroids, immunoglobulins or following surgical removal of the spleen. It was approved for use in Europe in March 2010 under the trade name Revolade as an oral treatment for thrombocytopenia (reduced platelet count) in adults with the blood disorder chronic immune (idiopathic) thrombocytopenic purpura (ITP). Eltrombopag is also approved under the trade name Revolade in Venezuela, Kuwait, Chile and Russia. Eltrombopag was discovered as a result of a research collaboration between GSK and Ligand Pharmaceuticals (NASDAQ:LGND), and developed by GSK.
About Ligand Pharmaceuticals
Ligand discovers and develops novel drugs that address critical unmet medical needs of patients for a broad spectrum of diseases including hepatitis, muscle wasting, Alzheimer's disease, dyslipidemia, diabetes, anemia, COPD, asthma, rheumatoid arthritis and osteoporosis. Ligand's proprietary drug discovery and development programs are based on advanced cell-based assays, tissue-specific receptor ligand interactions and gene-expression tools. Among its peers, we believe Ligand has assembled one of the largest portfolio of assets including commercial therapies developed in partnership with pharmaceutical companies. Ligand has established multiple alliances with the world's leading pharmaceutical companies including GlaxoSmithKline (GSK), Merck, Pfizer, Roche, Bristol-Myers Squibb and AstraZeneca.
Caution Regarding 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 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.
Source: Ligand Pharmaceuticals Incorporated
Released November 2, 2010