SAN DIEGO, May 25, 2012 (GLOBE NEWSWIRE) -- Apricus Biosciences, Inc. ("Apricus Bio" or the "Company") (APRI) (http://www.apricusbio.com) announced today that the Canadian Intellectual Property Office issued a Notice of Allowance for a Canadian patent on certain methods of manufacture for the Company's platform NexACT® drug delivery technology.
Specifically, the patent covers the synthesis of Dodecyl 2-(N, N-Dimethylamino)-Propionate (DDAIP) by a transesterification chemical process. DDAIP opens up the tight junctions between cells, allowing drugs to be delivered to the bloodstream.
The patent application (No. 2,706,680), entitled "Crystalline Salts of Dodecyl 2-(N, N-Dimethylamino)-Propionate, is a divisional application of the already issued Canadian Patent No. 2,338,139 bearing the same title and covering crystal salts of DDAIP. When issued, this patent will protect this method of manufacture of DDAIP in Canada, and provides patent exclusivity to May 2020.
The transesterification approach to synthesizing DDAIP represents an advance in the manufacturing process of this technology. The resulting product contains relatively lower levels of by-products and unreacted reactants, which are undesirable and difficult to remove by conventional methods. The Company expects this method to bring significant cost savings for the finished product. This will be the 17th patent granted for this technology worldwide, with two applications pending in this patent family.
In addition, the New Zealand Intellectual Property Office issued a Notice of Acceptance for New Zealand patent application number 576,242, entitled "Stabilized Prostaglandin E Composition," which claims formulations of Vitaros®, Apricus Bio's lead product candidate for the treatment of erectile dysfunction. When issued, this patent will grant exclusive rights to certain pharmaceutical compositions of Vitaros®—including its room temperature formulation in New Zealand. It will provide patent exclusivity until October 2027.
"These new patent allowances serve to further strengthen our global intellectual property positions," said Bassam Damaj, President and Chief Executive Officer of Apricus Bio. "We continue to pursue an aggressive patent strategy that we believe will protect the DDAIP compound and method of manufacture including those relating to our more advanced room temperature formulations, and we will meaningfully expand the market exclusivity of our products in important territories."
Apricus Bio currently owns approximately 144 issued patents and 143 patent applications, including eight allowed patent applications, on its NexACT® technology, its acquired products, and on other products and technologies throughout the world. Patents covering Vitaros®, for erectile dysfunction, have been issued in Australia, Canada, Eurasia, Europe, Hong Kong, Israel, Japan, Mexico, New Zealand, Singapore, South Africa, South Korea, Turkey, Taiwan, and the United States.
Vitaros® is a topically delivered formulation of alprostadil combined with the Company's proprietary NexACT® delivery technology for the treatment of erectile dysfunction (ED). The NexACT® delivery technology enhances the penetration of alprostadil through the skin. When absorbed through the skin, alprostadil, a vasodilator, directly boosts blood flow, thereby causing an erection.
Vitaros® differs from oral medications in two ways. First, it is applied locally, directly to the penis as a cream, instead of administered orally and absorbed systemically. This topical application helps to reduce side effects and provides a patient-friendly alternative for men who cannot take the existing oral medications. Second, clinical studies have shown that Vitaros® works in approximately 15 minutes on average, compared to a reported onset time of 30 minutes, or longer, for oral medications.
DDAIP is a small molecule permeation enhancer used in Apricus Bio's NexACT® drug delivery technology to enables rapid absorption of high concentrations of an active pharmaceutical ingredient directly at the target site and to enhance the delivery of an active drug to the patient. The NexACT® technology has been used in multiple Apricus Bio products, including Vitaros®, Femprox® and MycoVa™ and administered to over 5,000 patients in clinical studies.
About Apricus Biosciences, Inc.
Apricus Bio is a San Diego-based revenue-generating 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 (U.S.A.), Inc. subsidiaries and through out-licensing in certain territories of its product pipeline and NexACT® technology.
Apricus Bio's current NexACT® 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.
Apricus Bio currently markets Totect® (dexrazoxane HCl), the only drug approved in the US for the treatment of anthracycline extravasation. The Company also plans to market in the U.S. or certain other countries the following products: (a) Granisol® (granisetron HCI) oral solution, the only FDA-approved, oral, ready-to-use liquid solution of granisetron, (b) Aquoral™, an FDA-cleared, prescription-only spray for the treatment of Xerostomia (the medical term for dry mouth due to a lack of saliva) and (c) 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).
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.
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, its ability to further develop its products and product candidates, to have its products and product candidates such as Vitaros® receive patent protection and be approved by relevant regulatory authorities, to successfully commercialize such products as Vitaros® for erectile dysfunction and NexACT® product candidates and drug delivery technology and to achieve its development, commercialization and financial goals. 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 firstname.lastname@example.org
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