Apricus Biosciences Receives Notice of Issuance for First Prevonco™ Patent in the United States
SAN DIEGO, CA, April 26, 2012 (GLOBE NEWSWIRE) — Apricus Biosciences, Inc. (“Apricus Bio” or the “Company”) (Nasdaq:APRI) (http://www.apricusbio.com), announced today that the Company received an Issue Notification from the United States Patent and Trademark Office for U.S. Patent Application No. 12/138,603 entitled “Thiazole Compounds, and Compositions and Methods Using Same.” This soon-to-be issued patent claims certain compositions and methods for inhibiting tumor growth related to PrevOnco™, Apricus Bio’s proprietary Phase III-ready cancer treatment for patients with advanced, unresectable hepatocellular carcinoma (“HCC”), or liver cancer. When issued, the patent will provide patent protection into 2029 and will be the Company’s first granted patent in the United States for PrevOnco™.
The Company currently has two other PrevOnco™ patent applications pending in the United States. Worldwide, Apricus Bio has one granted patent for PrevOnco™ in Canada and 10 pending applications in Canada, China, European Union, Japan, Israel, Mexico, New Zealand, and South Korea. The Company is also developing oral PrevOnco™ applications that utilize its proprietary NexACT® technology platform to be used as the final product for the Phase III that is in discussion with the U.S. Food and Drug Administration (“FDA”).
PrevOnco™, which was granted Orphan Drug status by the FDA for HCC, is a novel formulation of lansoprazole, a commonly marketed anti-ulcer compound. The Company’s next stage in the FDA approval process is to run a human PK equivalency trial with the NexAct® formulation and bridge this formulation to the Phase III currently in discussion with the FDA.
Dr. Bassam Damaj, President and Chief Executive Officer of Apricus Bio commented, “This patent represents an important step forward in our effort to develop and commercialize PrevOnco™ for the treatment of HCC, as it provides a runway to realize the full clinical and commercial potential of this novel therapy. With strong intellectual property and exclusivity for PrevOnco™, our ongoing partnering efforts should be easier and hopefully faster.”
About Hepatocellular Carcinoma (HCC)
Hepatocellular carcinoma (HCC) is the seventh most common cancer in the world, with a high incidence in China and other Asian countries. Although uncommon in the U.S., there are a reported 8,500 to 11,000 new cases diagnosed each year, comprising 2% of all malignancies. Cases in the U.S. occur primarily in men of Chinese descent, a subpopulation which has a high incidence of viral hepatitis – a known risk factor for HCC.
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 (USA), 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, such as PrevOnco™, and product candidates, to have its products and product candidates receive patent protection and be approved by relevant regulatory authorities, to successfully commercialize such products as Totect®, Granisol®, Aquoral™ and NitroMist™ and 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.
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