Apricus Bio in discussions with FDA for PrevOnco SPA Phase III protocol

Feb 18 2011

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.