Apricus receives $733,437 grants under QTDP program

Nov 8 2010

Apricus Biosciences, Inc., ("Apricus Bio") (Nasdaq: APRI) today announced the award of three grants totaling $733,437 under the Qualifying Therapeutic Discovery Project program for PrevOnco^TM, RayVa^TM and Femprox^® which are the Company's development programs in cancer, autoimmune/cardiovascular and female sexual dysfunction, respectively. The credit is a tax benefit for 2010 expenditures awarded to therapeutic discovery projects that show a reasonable potential to result in new therapies that treat areas of unmet medical need or prevent, detect or treat chronic or acute diseases and conditions. Apricus Bio will use the proceeds of the grant funds to continue development of PrevOnco^™, RayVa^™ and Femprox^®.

Commenting on today's news, Dr. Bassam Damaj, President and Chief Executive Officer of Apricus Bio, stated, "We are very pleased to be one of the California companies that received more than one grant of the maximum 2010 credit allowed. The U.S. government, relying on the National Institutes of Health peer review process, has acknowledged the scientific merit of our three projects and deemed them worthy of financial support. The receipt of this grant award further bolsters our cash reserves as we continue the development of these three important pipeline product candidates."

PrevOnco, based on a marketed anti-ulcer compound, lansoprazole, is indicated for the treatment of solid tumors. Apricus Bio has filed an Investigational New Drug Application with the U.S. Food & Drug Administration (FDA) to begin testing in humans. Based on input from the FDA, the Company expects to submit before the end of 2010, the Special Protocol Assessment Phase 3 registration protocol for a comparator study against doxorubicin in Nexavar^® failure, which would be expected to support the filing of a New Drug Application for marketing approval in the U.S. and Europe, subject to positive data.

RayVa is a topical alprostadil-based treatment for Raynaud's syndrome, and Apricus Bio expects to submit to the FDA the Phase 3 protocol for Special Protocol Assessment for review before the end of 2010. Raynaud's is a disorder in which the fingers or toes (digits) suddenly experience decreased blood circulation, and is characterized by color changes of the skin of the digits upon exposure to cold or emotional stress.

Femprox is an alprostadil-based cream intended for the treatment of female sexual arousal disorder. The Company has completed nine clinical studies to date, including one, 98-patient Phase 2 study in the U.S. and a 400-patient proof-of-concept Phase 2/3 study in China. The Phase 2/3 study results showed that primary efficacy endpoint was statistically significant and patients showed demonstrable improvement in sexual arousal over the course of therapy.