GENTA WITHDRAWS GENASENSE MELANOMA NDA; REDUCES WORKFORCE
May 14, 2004
Faxwatch © 2004
Late Thursday, Genta Inc. notified the Food and Drug Administration of its decision to withdraw its New Drug Application for Genasense (oblimersen sodium injection), according to a press release.
Genta has requested a meeting with the FDA to review key issues and to identify next steps related to further development of the drug in the treatment of melanoma.
The NDA had been submitted in December 2003 for the use of Genasense plus dacarbazine for the treatment of patients with advanced melanoma. On May 3, an FDA advisory committee recommended against approval for the therapy.
Earlier Thursday, Genta said it will reduce its workforce by 45 percent, or 85 employees, in an initiative designed to conserve its resources and put a greater focus on Genasense.
The company added that it will cease actively marketing its only marketed therapy, Ganite (gallium nitrate injection), indicated to treat cancer-related hypercalcemia that is resistant to hydration.
“We anticipate that the steps we are taking today will conserve cash, thereby allowing time to collect and analyze data from ongoing and recently completed trials,” said Genta’s Chief Executive Dr. Raymond Warrell, Jr.
“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,” he added.
Shares of Genta closed at $4.85, up $0.17, or 3.6 percent, in moderate training on the Nasdaq. |
