US specialty drugmaker Bentley Pharmaceuticals says that two of its Spanish units have gained approval for a generic version of AstraZeneca’s prostate cancer drug Casodex.
Laboratorios Belmac and Laboratorios Davur units have been given the go-ahead by the Spanish Ministry of Health to sell a 50mg tablet of bicalutamide, the active ingredient in Casodex and the company will now apply for pricing in the Spanish market and will start building inventory for a launch.
John Sedor, Bentley’s president, noted that “this is our first generic product in the oncology area,” adding that the firm is continuing to leverage its expertise, “including proven formulation capabilities in solid oral dosage, to serve this important, growing market.”
The firm noted that Casodex has proved to be a “very expensive” drug for the Spanish health care system and quoted IMS Health data which estimated the annual market size for bicalutamide in Spain at about $65 million, up 12% over the last year. AstraZeneca’s 2006 global sales of Casodex were up 7% to just over $1.2 billion.