FDA taxes Genta

The FDA has voted not to recommend marketing approval of Genta/Aventis' Genasense antisense cancer drug.

In the absence of increased survival rates, the Oncologic Drugs Advisory Committee (ODAC) of the FDA voted that the evidence presented from the companies' Phase III trial of Genasense (oblimersen sodium) Injection in combination with dacarbazine (DTIC) versus dacarbazine alone did not provide substantial evi-ence of effectiveness. This is measured by response rate and progression-free survival, to outweigh the increased toxicity of administering Genasense for the treatment of patients with metastatic melanoma who have not received prior chemotherapy.

While the advisory committee's recommendation is not binding, the FDA will consider it as the agency completes its Priority Review of the New Drug Application (NDA) for Genasense.

As a result of this set back Genta has reduced its workforce by 85 employees, or approximately 45%, including its field sales employees. The Company also will cease actively marketing Ganite (gallium nitrate injection), its only marketed product.

'We strongly believe in the potential of Genasense and what it represents to patients with advanced melanoma,' said Dr Raymond Warrell Jr., Genta's chairman and ceo. 'We are committed to its ongoing development and we will work closely with the FDA to determine the appropriate next steps.'

'At the end of the 1st quarter, Genta had cash and cash equivalents totalling approximately $67m, and we anticipate that the steps we are taking today will conserve cash, thereby allowing time to collect and analyse data from ongoing and recently completed trials. The decision to cease active marketing of Ganite is especially difficult. However, given our funding priorities for Genasense, we no longer believe we can sustain the additional marketing and selling expenses that are required for Ganite to reach profitability.'

Genta filed its NDA for Genasense in December 2003 and was granted Priority Review. An FDA response on the Genasense NDA is expected by June 8, 2004. The NDA for Genasense is based on results from a Phase III randomised trial of Genasense plus dacarbazine in patients with advanced melanoma.

About Genasense

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 treatments for advanced melanoma. Genta and Aventis are pursuing a clinical development program with Genasense evaluating its potential to treat various forms of cancer.

About Advanced Melanoma

Advanced melanoma is the most deadly form of skin cancer because it has spread throughout the body forming secondary tumors. The incidence of melanoma has increased more rapidly than any other cancer, and has more than doubled in the last 30 years. According to the American Cancer Society, more than 55,000 cases of melanoma will be diagnosed in the US in 2004. Melanoma is the number one cause of cancer death in the United States for women aged 25 to 29, and it ranks second in incidence to breast cancer in women aged 30-34. Globally, 132,000 melanoma skin cancers will occur globally every year, according to the World Health Organisation.