Sunesis Pharmaceuticals Inc. announced that the European Commission has granted orphan drug designation to vosaroxin, the company’s lead development candidate, for the treatment of acute myeloid leukemia (AML). The designation provides for 10 years of marketing exclusivity in all EU member countries following product approval. Vosaroxin has previously received orphan drug and fast track designations from the U.S. Food and Drug Administration (FDA).
“The European Commission’s decision reinforces the global potential of vosaroxin and recognizes the desperate need for new treatment options in AML, an indication for which treatment standards have not changed appreciably in the past thirty years,” said Dr. Adam Craig, EVP Development & CMO of Sunesis. “European orphan drug designation is the latest in a series of regulatory milestones that have strengthened the commercial opportunity for vosaroxin on both sides of the Atlantic.
These include the potential for market exclusivity to 2030 and an expedited review process in the U.S., as well as new patents issued in the European Union with exclusivity to 2025.”
As established by the European Medicines Agency (EMA), orphan designation is granted to product candidates intended for the treatment of a life-threatening or chronically debilitating condition affecting no more than five in 10,000 persons in the European Union. It also provides for scientific advice and regulatory assistance from the EMA during the product development phase, direct access to centralized marketing authorization, and certain financial incentives for companies developing orphan drug candidates. Orphan drugs are eligible for a reduction of fees associated with pre-authorization inspections, as well as marketing authorization application fees and certain other fees for qualifying companies.
Sunesis is currently enrolling patients in its VALOR trial, a Phase 3, multinational, randomized, double-blind, placebo-controlled, pivotal clinical trial of vosaroxin in combination with cytarabine in first relapsed or refractory acute myeloid leukemia.
Date: May 3, 2012
Source: Sunesis Pharmaceuticals Inc.
Filed Under: Drug Discovery