Source: J Am Coll Cardiol  |  Posted 6 years ago

SAN DIEGO, CA -- September 27, 2005 -- SGX Pharmaceuticals, Inc., announced today that Troxatyl(TM) (troxacitabine) has been granted orphan drug status for the treatment of acute myeloid leukemia (AML) by the Committee for Orphan Medicinal Products of the European Medicines Agency (EMEA).

Troxatyl is currently in a pivotal Phase II/III clinical trial for the third-line treatment of AML. The company announced earlier in May that the Food and Drug Administration (FDA) had granted Troxatyl Orphan Drug Designation in the U.S. for the treatment of AML.

The EMEA orphan drug designation provides incentives to companies that develop drugs for diseases affecting no more than 50 in 100,000 persons in the European Union (EU) or drugs intended for a life-threatening, seriously debilitating, or serious and chronic condition, and for which there is no satisfactory authorized therapy or where the drug will provide a significant benefit.

The designation can potentially provide a drug 10 year EU market exclusivity for a particular indication. In addition, orphan drug status provides regulatory assistance, reduced regulatory fees associated with applying for marketing approval, and protocol assistance.

Orphan drug designation does not convey an advantage in, or shorten the duration of, the regulatory review and approval process and it is not marketing authorization, which can only be granted after the demonstration of the quality, safety and efficacy of the product.

SOURCE: SGX Pharmaceuticals, Inc.