LIGAND SUBMITS MAA FOR ONZAR IN EUROPE.
As a result of achieving this milestone, Ligand will receive a $1 million payment from its European marketing and distribution partner Elan.
Ligand also announced that ONZAR has been granted orphan drug designation by the European Commission. This designation currently provides, upon approval, 10 years of market exclusivity for the treatment of CTCL.
"We expect to work closely with the European regulatory authorities toward an efficient review and availability of this important new therapeutic for patients with CTCL," said David E. Robinson, Ligand's chairman, president and CEO. "ONZAR is our largest-selling product in the United States, where it is marketed as ONTAK(R) (denileukin diftitox). If approved in Europe, ONZAR will join Targretin(R) capsules and Panretin(R) gel, which were launched this quarter, and Targretin gel, whose MAA is under review, as we bring our U.S. product line to Europe."
Ligand applied to the European Agency for the Evaluation of Medicinal Products (EMEA) via the centralized procedure to market ONZAR for the treatment of persistent or recurrent CTCL in patients whose malignant cells express the p55 (CD25) component of the IL-2 receptor and who have received one or more prior systemic therapies.
The U.S. Food and Drug Administration approved ONTAK in the United States in February 1999. In the United States, clinical studies are being conducted to evaluate the safety and efficacy of ONTAK in large-market diseases, including T- and B-cell non-Hodgkin's lymphomas (NHL) and chronic lymphocytic leukemia (CLL). Promising early-stage research from the recent American Society of Hematology meeting showed that ONTAK had anti-cancer activity in CLL patients, and that combination treatment with Ligand's Targretin (bexarotene) boosted the activity of ONTAK in CTCL patients.
Ligand has exclusive agreements with three companies to market and distribute its near-term oncology products, when approved, outside the United States:
-- Ferrer International, S.A., in Spain, Portugal, Greece, and Central and South America.
-- Alfa Wassermann S.p.A. in Italy.
-- Elan Pharma International Limited for key markets including Germany, France, the United Kingdom and other Northern European countries.
Ligand Pharmaceuticals Incorporated discovers, develops and markets new drugs that address critical unmet medical needs of patients in the areas of cancer, skin diseases, men's and women's hormone-related diseases, osteoporosis, metabolic disorders, and cardiovascular and inflammatory diseases. Ligand's proprietary drug discovery and development programs are based on its leadership position in gene transcription technology.
Full prescribing information for Ligand's products can be obtained in the United States from Ligand Professional Services by calling 800-964-5836, or on Ligand's internet site at http://www.ligand.com.
For more information, call 858/550-7850.
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|Date:||Feb 1, 2002|
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