Ten days after an FDA panel voted against Genta Inc.'s lead drug candidate, the company laid off nearly half its work force in an effort to conserve cash.
The Berkeley Heights, N.J.-based company is lowering its head count by 85 employees, equal to about 45 percent of the company, including its field sales employees. In the process, Genta is halting all active promotion of its only marketed product, Ganite (gallium nitrate injection).
The moves come on the heels of negative feedback from the Oncologic Drugs Advisory Committee of the FDA, which voted not to recommend marketing approval of Genasense (oblimersen sodium). The rebuff, which came early last week, sent the company's stock value tumbling by more than 40 percent on each of two consecutive trading days. (See BioWorld Today, May 4, 2004.)
Since then, Genta has been named in a number of class-action lawsuits filed on behalf of shareholders.
"Our priority is Genasense, and our decision to cease marketing Ganite is [so we can] focus solely on Genasense," Joy Schmitt, a company spokeswoman, told BioWorld Today. "Job cuts were made throughout the company, from every department, so it was comprehensive throughout the organization."
On Thursday, the company's stock (NASDAQ:GNTA) gained 17 cents to close at $4.85.
Late last year, Genta submitted a new drug application for the use of Genasense in combination with dacarbazine for advanced melanoma. Given its funding priorities for Genasense, Genta said it does not believe it can sustain any additional marketing and selling expenses required for Ganite to reach profitability. Indicated for cancer-related hypercalcemia, the product generated $400,000 in sales during the last fiscal quarter.
The company, which reported $67 million in cash reserves as of March 31, said it would continue to collect and analyze data from ongoing and recently completed trials of Genasense.
"Genasense is the subject of more than 20 clinical trials, and we continue to develop it with the objective of obtaining marketing approval," Schmitt said of the injectable cancer product, which is partnered with Aventis SA. Their arrangement calls for co-promotion in the U.S., while Strasbourg, France-based Aventis owns the rights in other parts of the world.
The two-year-old development deal is valued at up to $480 million, and to date, Genta has collected about $250 million and would get another milestone for approval in the first indication. (See BioWorld Today, April 30, 2002.)
The partners' apparent regulatory setback stems from a 13-3 vote by the advisory panel that said small improvements in tumor response rates and progression-free survival, as shown in the pivotal Phase III trial, do not warrant approval given an increased chance of toxicity. A 771-patient trial did not show statistical significance on the survival endpoint, but approval is being sought based on favorable secondary endpoints of tumor response and progression-free survival.
Schmitt said two other randomized trials have completed enrollment - one in chronic lymphocytic leukemia and the other in multiple myeloma. Genta will release those data in the second half of this year.
The drug's use also is being investigated in treating acute and chronic myeloid leukemia, non-Hodgkin's lymphoma, and prostate, breast, lung and colorectal cancers.
"I can't comment on any FDA interactions," Schmitt said. "But certainly at this point melanoma remains a focus for us."
The FDA, which is not beholden to follow the panel's recommendation, is expected to act on or before June 8, the Prescription Drug User Fee Act III date.