In March 2008, the company has received notice that its appeal of an adverse decision by the FDA’s Center for Drug Evaluation and Research (CDER) regarding its new drug application (NDA) for the use of Genasense in chronic lymphocytic leukemia (CLL) patients 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%.
Raymond Warrell, Jr., Genta’s chairman and CEO, said: “The highest priority for the company is the timely completion of accrual and data readout from Agenda, our ongoing Phase III trial of Genasense in patients with advanced melanoma. 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, 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.”
Mr Warrell, also said: “I am very pleased that Lloyd Sanders has agreed to increase his leadership role in this consolidation as COO by assuming oversight responsibility for information technology, business development, manufacturing operations, and commercial operations.”