Genta
Incorporated (Nasdaq: GNTA) announced that the Company intends to request
review of a decision by officials from the Food and Drug Administration
(FDA) not to overturn FDA’s non-approvable decision for the New Drug
Application (NDA) for Genasense(R) (oblimersen sodium) Injection in
patients with relapsed or refractory chronic lymphocytic leukemia (CLL).
Following FDA’s established Dispute Resolution Process, Genta expects to
formally submit its request to Dr. Steven Galson, CDER Director, within the
next four weeks and the Company anticipates a decision from CDER in the
third quarter of 2007.
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(R) (oblimersen sodium)
Injection is the Company’s lead compound from its oligonucleotide program.
The leading drug in Genta’s small molecule program is Ganite(R) (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. Genta is partnered with IDIS
(idispharma) on a program whereby both Ganite(R) and Genasense(R)
are available on a “named-patient” basis in countries outside the United
States. For more information about Genta, please visit our website at:
genta.
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(R) 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 and any proposed settlement of such
litigation;
— the Company’s ability to regain compliance with the NASDAQ’s listing
qualifications, or its ability to successfully appeal the NASDAQ
delisting; 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 2006
and its most recent quarterly report on Form 10-Q.
Genta Incorporated
genta