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Company to Seek Buyer for Marketed Product Ganite(R) Lloyd Sanders Assumes Chief Operating Officer Role in Consolidated Company
BERKELEY HEIGHTS, N.J., April 2, 2008 /PRNewswire-FirstCall/ -- Genta Incorporated (Nasdaq: GNTA) today announced that the Company has restructured certain of its operations to conserve cash and focus on its priority oncology development operations. In March 2008, the Company received notice that its appeal of an adverse decision by the Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER) regarding its New Drug Application (NDA) for the use of Genasense(R) in patients with chronic lymphocytic leukemia (CLL) would not be reversed. While the Company is undertaking certain actions recommended by CDER, this decision precludes a commercial launch of Genasense during 2008, and accordingly the Company has reduced its workforce by 16 people, or approximately 30%.
"The highest priority for the Company is the timely completion of
accrual and data readout from AGENDA, our ongoing Phase 3 trial of
Genasense in patients with advanced melanoma", said Dr. Raymond P. Warrell,
Jr., Genta's Chairman and Chief Executive Officer. "Since these products
address important patient needs and generate revenue for the Company, we
will be maintaining our "named-patient" programs for Genasense and Ganite.
However, given the delays in commercialization of our lead product, we have
underinvested in our marketed drug, Ganite(R), and will be seeking buyers
for that product. In other actions, we expect to file a complete response
to FDA's clinical hold on tesetaxel, our new oral taxane, and we anticipate
clinical presentations on both Genasense and G4544 -- an oral compound that
reduces calciu
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