INNOVIVE Pharmaceuticals Announces Receipt of FDA Orphan Drug Designation for Tamibarotene for the Treatment of Acute Promyelocytic Leukemia
Published: Oct 15, 2007
NEW YORK--(BUSINESS WIRE)--INNOVIVE Pharmaceuticals, Inc. (OTCBB:IVPH) today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to the company’s drug candidate Tamibarotene for the treatment of adult patients with relapsed or refractory acute promyelocytic leukemia (APL) following treatment with all-trans-retinoic acid (ATRA) and arsenic trioxide. Orphan drug designation is granted by the FDA to encourage companies to develop products that treat rare diseases and conditions. Developers of orphan drugs are granted seven years of marketing exclusivity after approval of their orphan drug product as well as tax incentives for clinical research they have undertaken. In addition, the FDA coordinates research study design assistance for developers of drugs for rare diseases and conditions, and grant funding is available to defray costs of qualified clinical testing expenses incurred in connection with the development of orphan drug products.