Bentley Pharmaceuticals, Inc., a specialty pharmaceutical company, announced that its subsidiaries, Laboratorios Belmac and Laboratorios Davur, have received product approvals of bicalutamide from the Spanish Ministry of Health.

Bicalutamide is the generic equivalent to AstraZeneca Pharmaceuticals' Casodex. Bicalutamide is prescribed as a treatment to prevent the growth of prostate cancer by blocking the effects of androgens on the cancer cells. The treatment is a non-steroidal, anti-androgenic product orally administered as a 50 mg. tablet.

"This is our first generic product in the oncology area," said John Sedor, president Bentley Pharmaceuticals, Inc. "We are pleased to continue to leverage our generic expertise, including proven formulation capabilities in solid oral dosage, to serve this important, growing market."

The next steps towards market launch of bicalutamide for Bentley are to apply for product pricing and building inventory. According to IMS Health Inc., the annual market size for bicalutamide in Spain is approximately $65 million (USD) and has grown 12 per cent over the trailing twelve months. To date, this branded product has been very expensive for the healthcare system.