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.
"Melanoma is an especially serious public health problem in Australia," said Dr. Raymond P. Warrell, Jr., Genta's chief executive officer. "The recently published phase 3 study of Genasense plus dacarbazine included a large number of Australian participants and showed benefit across an array of clinical endpoints. Genta has retained a local agent in Australia to represent the company before the TGA, and we are very pleased that the TGA has granted the requested designation in melanoma. We will decide whether to proceed with a formal marketing application pending further discussions with regulatory authorities."
Genta has filed a Marketing Authorization Application (MAA) that is currently under review with the European Medicines Agency (EMEA) for the use of Genasense plus dacarbazine for treatment of patients with advanced melanoma. That application, which follows the same format that would be required for an Australian submission, is comprised of results from a randomized multinational trial of dacarbazine with or with Genasense in patients with advanced melanoma.
Genasense inhibits production of Bcl-2, a protein made by cancer cells that is thought to block chemotherapy-induced apoptosis (programmed cell death). By reducing the amount of Bcl-2 in cancer cells, Genasense may enhance the effectiveness of current anticancer treatment. Genta is pursuing a broad clinical development program with Genasense evaluating its potential to treat various forms of cancer.