Genasense

oblimersen sodium

Aventis and Genta Announce FDA Acceptance and Priority Review of New Drug Application for Genasense in Advanced Melanoma

STRASBOURG, FRANCE and BERKELEY HEIGHTS, NJ., February 6, 2004 -– Aventis and Genta (Nasdaq: GNTA) today announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for Genasense (oblimersen sodium), the first systemic antisense therapy for cancer. The NDA proposes the use of Genasense in combination with dacarbazine for the treatment of patients with advanced melanoma who have not previously received chemotherapy. In addition, the FDA granted Priority Review status to the application, which targets an agency action on or before June 8, 2004.

“The FDA’s decision to grant Genasense a priority review underscores the urgent and significant unmet need for an effective therapy for patients with advanced melanoma. Aventis and Genta are committed to developing and bringing Genasense to market to meet this need,” said Frank Douglas, M.D., Executive Vice President of Drug Innovation and Approval, and a Member of the Board of Management at Aventis.

“This New Drug Application represents the first clinical indication for a drug that promotes chemotherapy-induced apoptosis, the first systemic use of an antisense therapy, as well as the first new drug for patients with advanced melanoma in almost 30 years,” said Loretta M. Itri, M.D., Genta’s President, Pharmaceutical Development, and Chief Medical Officer. “During the review period, we will work closely with the FDA as we seek regulatory approval for this potential new treatment option for 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 (cell death). By reducing the amount of Bcl-2 in cancer cells, Genasense may enhance the effectiveness of current treatments for advanced melanoma.

About Melanoma
Advanced or malignant melanoma is the most deadly form of skin cancer. The incidence of this disease is increasing by approximately 4% annually in the US. In 2004, the American Cancer Society estimates more than 55,000 cases of malignant melanoma will have been diagnosed. Melanoma is the number one cause of cancer death in women aged 25 to 29.

Source: Aventis www.aventis.com

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Genta Completes Appeal of FDA Decision for Genasense in CLL - October 25, 2007

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FDA Extends Review Period for Genasense New Drug Application in Chronic Lymphocytic Leukemia - October 30, 2006

Briefing Documents Posted for FDA Committee Review of Genasense New Drug Application - September 5, 2006

Genta Announces FDA's Oncology Drug Advisory Committee Will Review Genasense as Treatment for Chronic Lymphocytic Leukemia - July 27, 2006

Genasense New Drug Application Accepted for Review by FDA - March 1, 2006

Genta Files New Drug Application for FDA Approval of Genasense Plus Chemotherapy for Patients with Advanced or Refractory Chronic Lymphocytic Leukemia - December 29, 2005

Genta Initiates New Drug Application for Genasense in Patients with Relapsed or Refractory Chronic Lymphocytic Leukemia - June 30, 2005

Genta Announces Withdrawal of New Drug Application for Genasense in Melanoma - May 13, 2004

FDA Advisory Committee Reviews Genasense For Use in Advanced Melanoma - May 3, 2004

Genta and Aventis Announce Genasense Expanded Access Program for Patients with Advanced Melanoma - April 20, 2004

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