GENTA INCORPORATED SAYS GENASENSE WINS ORPHAN DRUG OK IN AUSTRALIA

Genta Incorporated announced that its lead anticancer drug, Genasense (oblimersen), has received Orphan Drug designation from the Therapeutic Goods Administration (TGA), the regulatory authority in Australia. The designation was granted for the use of Genasense as treatment for patients with Stage IV malignant melanoma. Orphan Drug designation is intended to facilitate the development of drugs that address significant unmet medical needs, and it provides 7 years of market exclusivity after approval, grants and tax credits for research and development, and reduced filing fees for marketing applications.

BioSpace (http://www.biospace.com/news_story.aspx?StoryID=33353&full=1)