GENTA TO APPEAL GENASENSE NOT APPROVABLE LETTER

Genta has announced it will appeal the not approvable letter from the FDA for its new drug application (NDA) for the use of Genasense (oblimersen sodium) injection plus chemotherapy in patients with chronic lymphocytic leukemia (CLL). The company will file the appeal pursuant to the formal dispute resolution process that exists within the FDA's Center for Drug Evaluation and Research.

After the FDA's Oncologic Drugs Advisory Committee recommended against approving the application in September 2006, the FDA sent Genta a not approvable letter for its NDA for Genasense in CLL in December. The company filed notice reserving its rights to appeal after receiving the letter and expects to complete the filing this quarter.

Genta is also in discussions with the European Medicines Agency (EMEA) regarding the company's European marketing authorization application for Genasense for treating advanced melanoma. The company anticipates that the EMEA will issue its opinion regarding approval within the next few months.

Genasense inhibits production of Bcl-2, a protein made by cancer cells that is thought to block chemotherapy-induced apoptosis (programmed cell death). By reducing the amount of Bcl-2 in cancer cells, Genasense may enhance the effectiveness of current anticancer treatment. Genta is pursuing a broad clinical development program with Genasense evaluating its potential to treat various forms of cancer.