SAN DIEGO, 2012-02-03 15:41 CET (GLOBE NEWSWIRE) --
Apricus Biosciences, Inc. ("Apricus Bio" or the "Company") (Nasdaq:APRI)
(http://www.apricusbio.com) announced today the execution of a binding term
sheet with NovaDel Pharma Inc. ("NovaDel") (OTCBB:NVDL) for the sale and
license of rights in territories outside of the United States, Canada and
Mexico to NovaDel's NitroMist® (nitroglycerin sublingual spray), an
FDA-approved nitrate vasodilator indicated for acute relief of an attack or
acute prophylaxis of angina pectoris (chest pain) due to coronary artery
disease (narrowing of the blood vessels that supply blood to the heart).
NitroMist™ was developed using NovaDel's proprietary system, which is designed
to deliver a broad range of marketed drugs through the highly absorptive lining
of the mouth into the systemic blood circulation. NitroMist™ has a much longer
shelf-life than currently available sublingual tablet products, which offers
the potential benefit of greatly reduced waste due to product expiration.
Apricus currently intends to file for approval of NitroMist™ in multiple
international territories, including Europe. The potential worldwide market for
NitroMist™ is estimated at approximately $200 million.
Under the term sheet for the Sale Agreement, Apricus Bio will acquire patents,
patent applications, trademarks and trademark applications to NitroMist™ owned
or controlled by NovaDel outside the U.S., Canada and Mexico including an
exclusive, perpetual and royalty-free license to trade secrets and know how and
to the rights to commercialize the product outside of North America.
Dr. Bassam Damaj, Chairman, President and Chief Executive Officer of Apricus
Bio, stated, "NitroMist™ adds an additional drug with meaningful sales
potential to our growing portfolio of specialty pharmaceutical products and
product candidates. Further, it allows us to continue pursuing Apricus Bio's
focused strategy of expanding the Company's commercial arm worldwide. As with
our recently announced acquisition of ex-US rights to GRANISOL™, we will
continue to pursue smart acquisitions in important international markets that
will build Apricus Bio's international presence and offer the potential to
generate significant revenue over the long-term."
About Angina pectoris
Angina pectoris is the chest pain or discomfort due to coronary heart disease
and is typically a symptom of myocardial ischemia. It is estimated that 6 to 10
million Americans suffer from angina (Zaher, et. al. 2004, CDC, 2007). Nitrates
are the most common drugs used in patients with angina and patients are
instructed to use the drug ether to either treat or prevent an attack.
NITROMIST® WARNINGS AND PRECAUTIONS
Tolerance: Excessive use may lead to development of tolerance. Only the
smallest number of doses required for effective relief of the acute angina
attack should be used (see Dosage and Administration section of NitroMist® full
prescribing information).
As tolerance to other forms of nitroglycerin develops, the effect of sublingual
nitroglycerin on exercise tolerance, although still observable, is reduced.
Hypotension: Severe hypotension, particularly with upright posture, may occur
even with small doses of nitroglycerin. The drug should therefore be used with
caution in patients who may be volume-depleted or who, for whatever reason, are
already hypotensive. Hypotension induced by nitroglycerin may be accompanied by
paradoxical bradycardia and increased angina pectoris.
The benefits of NitroMist® in patients with acute myocardial infarction or
congestive heart failure have not been established. If one elects to use
NitroMist® in these conditions, careful clinical or hemodynamic monitoring must
be used because of the possibility of hypotension and tachycardia.
Hypertrophic Cardiomyopathy: Nitrate® therapy may aggravate the angina caused
by hypertrophic cardiomyopathy.
Headache: Nitroglycerin produces dose-related headaches, which may be severe.
Tolerance to headaches occurs.
About Apricus Biosciences, Inc.
Apricus Bio is a San Diego-based, revenue-generating, specialty pharmaceutical
company, with commercial products and a broad pipeline across numerous
therapeutic classes.
Revenues and growth are driven from the sales of the Company's commercial
products through its Apricus Pharmaceuticals USA, Inc. and NexMed (USA), Inc.
subsidiaries and through out-licensing in certain territories of its product
pipeline and NexACT® technology. Apricus Bio currently markets
Totect®(dexrazoxane HCl), the only drug approved in the US for the treatment of
anthracycline extravasation. Apricus Bio's current pipeline includes Vitaros®,
approved in Canada for the treatment of erectile dysfunction, as well as
compounds in development from pre-clinical through pre-registration currently
focused on Sexual Dysfunction, Oncology, Dermatology, Autoimmune, Pain,
Anti-Infectives, Diabetes and Consumer Healthcare.
The Company also expects to develop and/or acquire and then bring to market
additional pharmaceutical products in areas of care that will benefit patient
needs worldwide.
For further information on Apricus Bio, visit http://www.apricusbio.com, and
for information on its subsidiary please visit http://www.nexmedusa.com. You
can also receive information at http://twitter.com/apricusbio and
http://facebook.com/apricusbio.
Apricus Bio's Forward-Looking Statement Safe Harbor
Statements under the Private Securities Litigation Reform Act, as amended: with
the exception of the historical information contained in this release, the
matters described herein contain forward-looking statements that involve risks
and uncertainties that may individually or mutually impact the matters herein
described for a variety of reasons that are outside the control of the Company,
including, but not limited to, the ability to consummate the acquisition of
certain NitroMist™ assets of NovaDel, its ability to further develop its and
their products and product candidates, to have its products and product
candidates approved by relevant regulatory authorities, to successfully
commercialize such NexACT® products and product candidates, to achieve its
development, commercialization and financial goals in the U.S. and in other
countries and to close the acquisition of certain NitroMist™ assets of NovaDel
among other potential future acquisitions of companies and products. Readers
are cautioned not to place undue reliance on these forward-looking statements
as actual results could differ materially from the forward-looking statements
contained herein. Readers are urged to read the risk factors set forth in the
Company's most recent annual report on Form 10-K, subsequent quarterly reports
filed on Form 10-Q and other filings made with the SEC. Copies of these reports
are available from the SEC's website or without charge from the Company.
CONTACT: Apricus Bio Investor Relations:
David Pitts
Argot Partners
212-600-1902
david@argotpartners.com