BERKELEY HEIGHTS, NJ - December 20, 2006-
Genta Incorporated (NASDAQ: GNTA) today announced that the
Company has restructured certain of its operations to conserve cash
and focus on its oncology development operations. Last week, the
Company received notice that its New Drug Application for the use
of Genasense in patients with chronic lymphocytic leukemia was not
approved by the Food and Drug Administration. While Genta is
currently reviewing its options for response to this action, the
Company has reduced its workforce by 34 people, or approximately
35%. Genta has a Marketing Authorization Application (MAA) pending
in Europe for its lead anticancer drug, Genasense® (oblimersen
concentrate solution for injection), in patients with advanced
melanoma.
"At the end of the 3rd quarter, Genta had cash and cash
equivalents totaling approximately $40 million dollars, and today's
actions will result in severance costs of approximately $700,000",
said Dr. Raymond P. Warrell, Jr., Genta's Chairman and Chief
Executive Officer. "Review of the MAA is progressing in Europe, and
we currently anticipate a decision by the CHMP for the European
Medicines Agency in the first quarter of 2007. The steps we are
taking today will conserve cash, while still allowing us to
commercialize Genasense in Europe, retaining our options for the
U.S. and focusing our capabilities in oncology drug
development."
About Genasense
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.
About Genta
Genta Incorporated is a biopharmaceutical company with a
diversified product portfolio that is focused on delivering
innovative products for the treatment of patients with cancer. The
Company's research platform is anchored by two major programs that
center on oligonucleotides (RNA- and DNA- based medicines) and
small molecules. Genasense® (oblimersen sodium) Injection is the
Company's lead compound from its oligonucleotide program. Genta has
completed a pending Marketing Authorization Application to the
European Medicines Agency (EMEA) for use of Genasense plus
dacarbazine for treatment of patients with advanced melanoma. The
leading drug in Genta's small molecule program is Ganite® (gallium
nitrate injection), which the Company is exclusively marketing in
the U.S. for treatment of symptomatic patients with cancer related
hypercalcemia that is resistant to hydration. For more information
about Genta, please visit our website at:
http://www.genta.com/
.
Safe Harbor
This press release may contain forward-looking statements
with respect to business conducted by Genta Incorporated. By
their nature, forward-looking statements and forecasts involve
risks and uncertainties because they relate to events and depend
on circumstances that will occur in the future. Forward-looking
statements include, without limitation, statements about:
-
the Company's ability to obtain necessary regulatory
approval for Genasense® from the U.S. Food and Drug
Administration ("FDA") or European Medicines Agency
("EMEA");
-
the safety and efficacy of the Company's products or
product candidates;
-
the Company's assessment of its clinical trials;
-
the commencement and completion of clinical trials;
-
the Company's ability to develop, manufacture, license and
sell its products or product candidates;
-
the Company's ability to enter into and successfully
execute license and collaborative agreements, if any;
-
the adequacy of the Company's capital resources and cash
flow projections, and the Company's ability to obtain
sufficient financing to maintain the Company's planned
operations;
-
the adequacy of the Company's patents and proprietary
rights;
-
the impact of litigation that has been brought against the
Company and its officers and directors;
-
the Company's ability to regain compliance with the
NASDAQ's listing qualifications; and
-
the other risks described under Certain Risks and
Uncertainties Related to the Company's Business, as contained
in the Company's Annual Report on Form 10-K and Quarterly
Report on Form 10-Q.
The Company does not undertake to update any forward-looking
statements. There are a number of factors that could cause actual
results and developments to differ materially. For a discussion
of those risks and uncertainties, please see the Company's Annual
Report on Form 10-K for 2005 and its most recent quarterly report
on Form 10-Q.
SOURCE: Genta Incorporated
CONTACTS:
Investor Relations
Tara Spiess/Andrea Romstad
TS Communications Group, LLC
info@genta.com
(908) 286-3980
