Ligand Announces Approval for Revolade(R) in Europe
SAN DIEGO-- Ligand Pharmaceuticals Incorporated (NASDAQ:LGND) today announced that GlaxoSmithKline (NYSE: GSK) was granted marketing authorization from the European Commission (EC) for Revolade(R) (eltrombopag) for the oral treatment of thrombocytopenia (reduced platelet count) in adults with the blood disorder chronic immune (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 was submitted for approval in Europe in December 2008, and received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) in December 2009. European Commission has granted orphan designation for eltrombopag for the treatment of ITP. Eltrombopag is the first oral platelet generator that stimulates the proliferation and differentiation of megakaryoctes, resulting in an increase in platelet counts. Megakaryocytes are the bone marrow cells that give rise to blood platelets.
"The marketing authorization from the EC of Revolade highlights Ligand's success in entering pharmaceutical relationships that ultimately result in market approval. Revolade represents a significant treatment option available for ITP patients and the European approval expands the commercial potential for the drug," said John L. Higgins, President and Chief Executive Officer of Ligand Pharmaceuticals.
Eltrombopag was given accelerated approval by the U.S. 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 surgical removal of the spleen. 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, and developed by GSK.
Revolade(R) and Promacta(R) are registered trade marks of the GlaxoSmithKline group of companies.
About Ligand Pharmaceuticals
Ligand discovers and develops new drugs that address critical unmet medical needs of patients for a broad spectrum of diseases including hepatitis, muscle wasting, frailty, inflammatory diseases, anemia, asthma, rheumatoid arthritis and osteoporosis. Ligand's proprietary drug discovery and development programs are based on advanced cell-based assays, gene-expression tools, ultra-high throughput screening and one of the world's largest combinatorial chemical libraries. Ligand has strategic alliances with major pharmaceutical and biotechnology companies, including GlaxoSmithKline, Merck, Pfizer, Roche, Celgene, and Cephalon and more than 30 molecules are in various stages of development by its partners.
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
Released March 12, 2010