BERKELEY HEIGHTS, NJ, September 20, 2001
- Genta Incorporated (Nasdaq: GNTA) announced today that the
Company has received notice from the U.S. Food and Drug
Administration that Genasense
TM
, its lead anticancer compound, has been granted Fast Track
designation for multiple myeloma. Genasense
TM
had previously received such designation for treatment of
patients with malignant melanoma. The Company has randomized, Phase
3, clinical trials ongoing in both diseases at multiple sites in
the U.S., Canada, and Europe.
Separately, the Company also announced it has received notices
of approvability from the European Agency for the Evaluation of
Medicinal Products (EMEA) - the European Community equivalent of
the FDA - for the designation of Genasense
TM
as an "Orphan Drug" for the treatment of both multiple
myeloma and chronic lymphocytic leukemia.
"These new designations point to the ongoing dialog we have
pursued with regulatory authorities worldwide in order to ensure
that our development programs address global requirements", noted
Paul F. Manley, C.Biol., Gentas Vice-President for Regulatory
Affairs, who also observed: "Assuming a successful outcome in the
clinical trials, the Fast Track designations will enable timely
reviews of our NDA filings."
Dr. Raymond P. Warrell, Jr., Gentas Chief Executive Officer,
also commented: "A core feature of the Companys regulatory and
marketing strategy is the sequence of supplemental NDAs that can be
submitted on a regular basis after our initial approval. The
multiple Fast Track designations for Genasense
TM
provide us additional options and flexibility regarding both
the selection and timing of these submissions in order to maximize
our opportunity with this drug. On a global basis, the multiple
Orphan Drug designations in the E.U. will facilitate accelerated
approvals in these indications by an ex-U.S. partner."
