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lundi 6 février 2012 à 9h59

Biosciences Announces Acquisition of NitroMist(TM) Rights Outside North America (AcT)


SAN DIEGO, Feb. 3, 2012 (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


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http://www.actusnews.com/documents_communiques/ACTUS-0-26626-Apricus-Biosciences-Announces-Acquisition-of-NitroMist.pdf
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