-Federal Grants Further Bolster Company’s Cash Reserves-
SAN DIEGO--(BUSINESS WIRE)-- 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 PrevOncoTM, RayVaTM 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.
About the Qualifying Therapeutic Discovery Project Tax Credit
The Qualifying Therapeutic Discovery Project tax credit was enacted as part of the Patient Protection and Affordable Care Act of 2010. Allocation of the credit took into consideration which projects showed the greatest potential to create and sustain high-quality, high-paying U.S. jobs and to advance U.S. competitiveness in life, biological and medical sciences.
About Apricus Biosciences
Backed by NexMed, USA and Bio-Quant, Inc., its revenue generating CRO business, Apricus Bio has leveraged the flexibility of its proven NexACT® drug delivery technology to enable multi-route administration of new and improved compounds across numerous therapeutic classes. Future growth is expected to be driven primarily through out-licensing of this technology for the development and commercialization of such compounds to pharmaceutical and biotechnology companies, worldwide. Concurrently, the Company is seeking to monetize its existing product pipeline, including compounds from pre-clinical through Phase 3, currently focused on dermatology, sexual dysfunction and cancer. For further information on Apricus Bio and its subsidiaries, visit http://www.apricusbio.com.
Forward-Looking Statement Safe Harbor
Statements under the Private Securities Litigation Reform Act: 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 replicate pre-clinical study results in subsequent human clinical studies, meet projected regulatory timelines, enter into partnership agreements and successfully execute business plans. 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 and subsequent quarterly reports filed on Form 10-Q. Copies of these reports are available from the SEC's website or without charge from the Company.
KEYWORDS: United States North America California
INDUSTRY KEYWORDS: Health Biotechnology Oncology Pharmaceutical