Company to Seek Buyer for Marketed Parenteral Product
Ganite®
BERKELEY HEIGHTS, NJ - April 14, 2008
- Genta Incorporated (NASDAQ: GNTA) today announced that the
Company has received notice that its patent application covering
novel pharmaceutical gallium compositions and complexes has been
allowed by the U.S. Patent Office. Issued U.S. Patent
7,354,952 extends the intellectual property surrounding the
Company's franchise of oral gallium-containing products that are
intended as potential treatment for diseases associated with
accelerated bone loss. The lead compound in this
investigational pipeline, G4544, was developed in collaboration
with Emisphere Technologies, Inc. (NASDAQ: EMIS) and has completed
its initial Phase 1 dose-ranging study. Results of this study
will be presented at the Annual Meeting of the American Society of
Clinical Oncology (ASCO) that takes place in Chicago, IL from May
30-June 3, 2008.
With continued progress in the oral formulation program, the
Company has elected to seek a buyer for the intravenous formulation
of its on-market product from this franchise, Ganite® (gallium
nitrate injection). The active ingredient in both Ganite and
G4544 is ionic gallium, which is reversibly incorporated into bone
where its acts as a potent inhibitor of bone resorption and
possibly as a mild anabolic agent to enhance bone formation.
Ganite is approved by the U.S. Food and Drug Administration for
treatment of patients with cancer-related hypercalcemia that is
resistant to hydration. Ganite is exclusively marketed in the
U.S. by Genta and is available to patients outside the U.S. on a
"named-patient" basis.
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. Two major programs
anchor the Company's
research platform
: DNA/RNA-based Medicines and Small Molecules.
Genasense® (oblimersen sodium)
Injection is the Company's lead compound from its DNA/RNA Medicines
program. Genta is currently recruiting patients to the
AGENDA
Trial
, a global Phase 3 trial of Genasense in 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. The Company has developed
G4544
, an oral formulation of the active ingredient in Ganite, that has
recently entered clinical trials as a potential treatment for
diseases associated with accelerated bone loss. The Company
is also developing
tesetaxel
, a novel, orally absorbed, semi-synthetic taxane that is in the
same class of drugs as paclitaxel and docetaxel. Ganite and
Genasense are available on a "
named-patient
" basis in countries outside the United States. 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 and any proposed
settlement of such litigation;
- the Company's ability to retain 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 2007 and its most recent
quarterly report on Form 10-Q.
SOURCE: Genta Incorporated
CONTACT:
Genta Investor Relations
908-286-3980
info@genta.com
