Apricus Biosciences Announces First Patient Enrolled in Phase 2a Clinical Trial for RayVa(TM) in Patients With Raynaud's Phenomenon

SAN DIEGO, Dec. 4, 2014 (GLOBE NEWSWIRE) -- Apricus Biosciences, Inc. (Nasdaq:APRI), a biopharmaceutical company advancing innovative medicines in urology and rheumatology, today announced that the first patient has been enrolled in the Phase 2a clinical trial to evaluate RayVa, Apricus' product candidate for the treatment of Raynaud's phenomenon secondary to scleroderma. RayVa combines alprostadil, a potent vasodilator, with Apricus' proprietary permeation enhancer DDAIP.HCl, and is applied as an on-demand topical cream to affected extremities.

"Raynaud's phenomenon is a near universal feature of scleroderma and causes pain, loss of hand function and is associated with fingertip ulcerations and loss of finger substance. A topical therapy such as RayVa has the ability to improve blood flow locally without systemic adverse effects and has the potential to alleviate symptoms and possibly prevent finger injury," said Dr. James R. Seibold, an internationally recognized researcher in both scleroderma and Raynaud's phenomenon and the Principal Member of Scleroderma Research Consultants, LLC.

The randomized, double-blind, placebo-controlled, Phase 2a clinical trial is expected to enroll approximately 45 patients with Raynaud's phenomenon secondary to scleroderma. Each patient will receive applications of placebo and one of three different doses of RayVa, in a crossover design. This dose-ranging study will evaluate hemodynamics, skin temperature at the site of application, as measured by Laser Doppler and thermography, and symptomatic response following a standardized cold challenge. Other endpoints include safety and pharmacokinetic assessments.

"The dosing of the first patient in the RayVa Phase 2a clinical trial is a significant milestone for the Company, and importantly, for Raynaud's patients, as we seek to address with RayVa, the symptoms associated with this chronic condition," said Rich Pascoe, Chief Executive Officer. "Moreover, with the expected completion of the RayVa Phase 2a clinical trial, coupled with the anticipated start of the Phase 2b clinical trial of fispemifene in the first half of 2015 in men with secondary hypogonadism, Apricus is well positioned to drive value from its development-stage pipeline next year."

About RayVa™

RayVa is the proprietary name for Apricus' product candidate for the treatment of Raynaud's phenomenon associated with scleroderma (systemic sclerosis). The RayVa product combines alprostadil (prostaglandin E1), a potent vasodilator, with Apricus' proprietary permeation enhancer, and is applied as an on-demand topical cream to affected extremities. Apricus initiated a Phase 2a clinical trial following promising animal data. RayVa may qualify for FDA Priority Review, given the unmet medical need and lack of approved products in the United States to treat secondary Raynaud's phenomenon in patients with systemic sclerosis. Apricus anticipates submitting a New Drug Application for RayVa as early as 2017.

About Raynaud's Phenomenon

Raynaud's phenomenon (RP) is characterized by vasoconstriction in response to cold or stress of the hands and feet, resulting in reduced blood flow and the sensation of pain, which can be severe. Primary Raynaud's phenomenon, which is not associated with an underlying medical condition, affects an estimated 3-5% of the US population.1 Secondary Raynaud's phenomenon, is driven by an underlying medical condition, such as scleroderma, lupus or rheumatoid arthritis.2 Symptoms are severe and patients risk associated fingertip ulcerations. There are an estimated 100,000 adult patients with scleroderma in the US3, of which approximately 90% have secondary Raynaud's phenomenon2. Overall, there are approximately 500,000 adult patients with secondary Raynaud's phenomenon in the US.2, 4

Approximately 80% of scleroderma patients are women.5 Both primary and secondary Raynaud's phenomenon disproportionately affects women.6 There is currently no approved therapy for Raynaud's phenomenon in the United States, representing an unmet medical need.

About Apricus Biosciences, Inc.

Apricus Biosciences, Inc. (APRI) is a biopharmaceutical company advancing innovative medicines in urology and rheumatology. Apricus' lead product, Vitaros®, for the treatment of erectile dysfunction, is approved in Europe and Canada and commercialized in several countries in Europe. Apricus' marketing partners for Vitaros include Abbott Laboratories Limited, Takeda Pharmaceuticals International GmbH, Hexal AG (Sandoz), Recordati Ireland Ltd. (Recordati S.p.A.), Bracco S.p.A. and Laboratoires Majorelle. Apricus' second-generation Vitaros room temperature device is under development and is expected to enhance the product's commercial value. Apricus recently commenced a Phase 2a trial for RayVa™, Apricus' product candidate for the treatment of Raynaud's phenomenon. Femprox®, Apricus' product candidate for the treatment of female sexual interest/arousal disorder, has successfully completed an approximately 400-subject proof-of-concept study. Apricus is currently seeking a strategic partner for Femprox. In October 2014, Apricus gained U.S. development and commercialization rights for fispemifene, a selective estrogen receptor modulator for the treatment of male secondary hypogonadism, chronic prostatitis and lower urinary tract symptoms, in Phase 2 development.

For further information on Apricus, visit http://www.apricusbio.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act, as amended. Statements in this press release that are not purely historical are forward-looking statements. Such forward-looking statements include, among other things: statements regarding the ability of Apricus' management team to successfully carry out planned development programs for fispemifene and RayVa; references to the timing of the commencement of a Phase 2b clinical trial for fispemifene and the submission of a New Drug Application for RayVa. Actual results could differ from those projected in any forward-looking statements due to a variety of reasons that are outside the control of Apricus, including, but not limited to: results of future clinical trials of fispemifene and RayVa; potential adverse side effects or other safety risks associated with fispemifene and RayVa that could delay or preclude approval; Apricus' ability to obtain and maintain intellectual property protection for RayVa, fispemifene or any other product candidates; Apricus' ability to obtain additional financing in order to complete the development and commercialization of its product candidates; Apricus' ability to attract and retain senior management and key scientific personnel, which are necessary to successfully carry out planned development and operate Apricus' business; and market conditions. These forward-looking statements are made as of the date of this press release, and Apricus assumes no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those projected in the forward-looking statements. Readers are urged to read the risk factors set forth in Apricus' 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 at www.sec.gov or without charge from Apricus.

1 Wigley FM. Raynaud's phenomenon. N Engl J Med. 2002; 347:1001–1008.

2 Pope JE. The Diagnosis and Treatment of Raynaud's Phenomenon. Drugs 2007; 67: 517-525.

3 Barnes J and Mayes MD. Epidemiology of systemic sclerosis: incidence, prevalence, survival, risk factors, malignancy, and environmental triggers. Curr Opin Rheumatol 2012, 24:165–170.

American College of Rheumatology (http://www.rheumatology.org/Practice/Clinical/Patients/Diseases_And_Conditions/Scleroderma).

4 2012 U.S. Census Bureau: State and County QuickFacts (http://quickfacts.census.gov/qfd/states/00000.html).

5 Gelber AC, Manno RL, Shah AA, Woods A, Le EN, Boin F, Hummers LK, Wigley FM. Race and Association With Disease Manifestations and Mortality in Scleroderma. Medicine 2013; 92: 191-205.

6 National Institutes of Health (http://www.nhlbi.nih.gov/health/health-topics/topics/raynaud/atrisk).

CONTACT: Steve Martin Apricus Biosciences Chief Financial Officer ir@apricusbio.com (858) 222-8041 Institutional Investors: Angeli Kolhatkar akolhatkar@burnsmc.com Media: Justin Jackson jjackson@burnsmc.com Burns McClellan (212) 213-0006 Retail Investors: Chris Eddy, David Collins apri@catalyst-ir.com Catalyst Global (212) 924-9800

Source:Apricus Biosciences, Inc.