Genta will take sole control of the oncologic Genasense (oblimersen) effective May 8 after Sanofi-Aventis decided to drop out of the co-development agreement.

Sanofi-Aventis' termination of the deal came after Genta declined to modify the terms, Genta said Nov. 9. Genta announced that Sanofi has exercised its six-month termination rights Nov. 8.

The announcement of the collaboration's collapse came six months after FDA's Oncologic Drugs Advisory Committee concluded at a May 3 meeting that Genasense failed to show an effect on progression-free survival in malignant melanoma (¹ Also see "Genasense Melanoma Progression-Free Survival Data Do Not Show "Real Effect," Cmte. Says" - Pink Sheet, 3 May, 2004.).

Genta and Aventis withdrew the NDA after the ODAC meeting. Genta later said it was shifting the development focus for oblimersen to multiple myeloma and chronic lymphocytic leukemia (² Also see "Genta Targeting Year-End Genasense NDA In Myeloma Or Lymphocytic Leukemia" - Pink Sheet, 3 August, 2004.).

"It does appear that Aventis was counting on a 2004 launch as a key basis for their investment, and the ODAC setback in melanoma represented a major shortfall in their expectations," Genta CEO Raymond Warrell said during a Nov. 9 earnings call.

"I should note that Aventis did approach us on several occasions since the May ODAC to modify the financial terms of our agreement to conditions that were more favorable to them; however, we have declined to make those accommodations," Warrell said.

Sanofi's announcement on the termination of the Genasense collaboration also references the negative ODAC review and appears to raise questions about the viability of a chronic lymphocytic leukemia indication.

"At the time the agreements with Genta were entered into, Aventis was seeking a late-stage development opportunity that could potentially provide for a near term launch of product," Sanofi-Aventis said.

"After careful investigation, Aventis has determined it cannot continue to support the development of Genasense for the contemplated indications, given the recommendation of the ODAC of the FDA with respect to melanoma, and the recent results of the CLL (chronic lymphocytic leukemia) Phase III clinical trial."

Under the 2002 collaboration agreement valued at $480 mil., Aventis and Genta were to develop and co-market Genasense in the U.S., with Aventis having exclusive development and marketing rights outside the U.S.

Aventis was to fund 75% of NDA related development expenses in the U.S. and 100% of all other development, marketing and sales expenses worldwide. In exchange, Genasense was to receive sales royalties, licensing and development fees, convertible debt and a line of credit.

Genta will now assume the full burden of the costs and full marketing rights effective May 8.

Genta released results of the Phase III CLL study the same day it announced Sanofi's termination of the collaboration (see ³ Also see "Genasense CLL Trial Meets Primary Endpoint, But Survival Benefit Not Yet Shown" - Pink Sheet, 9 November, 2004.).

The CLL study met its primary endpoint of complete remission or nodular partial remission, Genta said. However, use of Genasense resulted in no significant difference in the secondary endpoints of time-to-progression and overall survival, the company said.

- Sue Sutter

Sanofi-Aventis Drops Genasense After Genta Declines To Modify Deal

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