SAN DIEGO, Feb. 17, 2011 (GLOBE NEWSWIRE) -- Apricus Biosciences, Inc. ("Apricus Bio") (Nasdaq:APRI), announced today that it is currently in discussions with the U.S. Food and Drug Administration ("FDA") relating to the PrevOnco™ Special Protocol Assessment ("SPA") Phase III protocol submitted by the Company in December 2010.
In the first response received by Apricus Bio relating to this SPA, the FDA accepted some of the questions submitted by the Company and commented on the rest. The Company's Clinical Advisory Board, formed to focus on the clinical development of PrevOnco™, Apricus Bio's first oncology compound, will meet in late February to discuss the FDA response and comments, and the Company will prepare a response according to feedback from the Clinical Advisory Board. In addition, the Company may request a meeting with the FDA to accelerate the FDA's SPA Phase III protocol review process.
Dr. Bassam Damaj, President and Chief Executive Officer of Apricus Bio, noted, "We will continue to work diligently with the FDA and respond to their comments as expeditiously as possible."
PrevOnco™ is Apricus Bio's proprietary treatment for hepatocellular carcinoma (liver cancer). The Company announced in late November 2010 that it intended to file the protocol for a proposed Phase III clinical trial of PrevOnco™ with the FDA. Pursuant to the FDA's SPA program, the agency provides approval for the trial's design, clinical endpoints and statistical analysis. A company's SPA is not considered accepted until the FDA comments and agrees to all of the questions and protocol design submitted therein. Once the SPA is accepted, the PrevOnco™ Phase III study is expected to take about 12-24 months, depending on patient recruitment. If the trial shows positive results within the parameters agreed upon in the SPA, the data would then be expected to provide the basis for the filing of a New Drug application for marketing approval of PrevOnco™ for the treatment of liver cancer in the U.S.
The FDA granted PrevOnco™ Orphan Drug status in August 2008. The product incorporates lansoprazole, a commonly marketed anti-ulcer compound which has shown strong anti-cancer activity in mice bearing human liver tumors. Upon acceptance of the SPA, the Company expects that the Phase III study will enroll up to 218 patients who have advanced, unresectable hepatocellular carcinoma who no longer respond to Nexavar® (the currently marketed first-line anti-cancer treatment for patients with this type of liver cancer). The subjects will receive Nexavar® and doxorubicin (the widely used chemotherapy anti-cancer drug), plus either PrevOnco™ or a placebo. Nexavar® is marketed in the U.S. by Onyx Pharmaceuticals, Inc. and Bayer HealthCare Pharmaceuticals, Inc., with close to $1 billion in sales, and is approved in more than 90 countries for the treatment of patients with hepatocellular carcinoma.
About Special Protocol Assessment
The FDA's Special Protocol Assessment process was implemented under the Prescription Drug User Fee Act (PDUFA) in November 1997. The SPA process provides for review and a binding agreement that the Phase III trial protocol design, clinical endpoints, planned conduct and statistical analyses are acceptable to support regulatory approval. The SPA process is normally a multi-step negotiation process with the FDA which may take up to a year pending FDA review.
About Apricus Biosciences, Inc.
Apricus Bio, a San Diego based revenue-generating pharmaceutical company, has leveraged the flexibility of its clinically-validated NexACT® drug delivery technology to enable multi-route administration of new and improved compounds across numerous therapeutic classes.
Revenues and growth are driven from out-licensing of this technology for the development and commercialization of such compounds to pharmaceutical and biotechnology companies worldwide. In addition, the Company is seeking to monetize its existing product pipeline, including its first product, Vitaros®, approved in Canada for the treatment of erectile dysfunction, which is currently expected to be available on the Canadian market in 2011, as well as compounds in development from pre-clinical through Phase III, currently focused on Sexual Dysfunction, Oncology, Dermatology, Autoimmune, Pain, Anti-Infectives, Diabetes and Cosmeceuticals among others.
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, FDA review of the PrevOnco™ SPA Phase III protocol FDA approval of the marketing of PrevOnco™ and commercialization of PrevOnco™, timing for seeking approvals for Vitaros® for erectile dysfunction and for a chemical formulation similar to Vitaros® for premature ejaculation, timing and success of the commercial launch of Vitaros® in Italy, The Gulf Countries and part of the Middle East and in Israel and the Palestinian Territories, the potential size of the market, the ability to develop and commercialize the Company's products on its own and with partners and the ability to meet its milestones. 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.
Apricus Biosciences, Inc.
Edward Cox, V.P.
Investor Relations & Corporate Development, Apricus Bio, Inc.
Apricus Bio Investor Relations
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