Apricus Biosciences Announces Multi-Year Partnership With the Scleroderma Research Foundation

By GlobeNewswire,  August 08, 2014, 07:30:00 AM EDT


SAN DIEGO, Aug. 8, 2014 (GLOBE NEWSWIRE) -- Apricus Biosciences, Inc. (Nasdaq:APRI), a pharmaceutical company focusing on the development and commercialization of novel therapeutics for men's and women's health, today announced a multi-year partnership agreement with the Scleroderma Research Foundation (SRF) to support the foundation's activities and the further progress of SRF's groundbreaking research programs. As part of the partnership, Apricus will co-sponsor an upcoming Scleroderma Research Roundtable Series and plans to participate in SRF's Annual Scientific Workshop and an SRF-sponsored event to take place at the upcoming American College of Rheumatology (ACR) 2014 Annual Meeting.

Scleroderma is an autoimmune disease characterized by widespread vascular abnormalities, immune dysregulation and fibrotic complications affecting multiple organs, including the skin.  Scleroderma commonly leads to other medical conditions, such as Raynaud's phenomenon (RP), a condition characterized by vasoconstriction in the hands, feet or other extremities, resulting in reduced blood flow and the sensation of pain, which can become severe.  There are an estimated 100,000 adult patients with scleroderma in the US1, of which approximately 90% have secondary Raynaud's phenomenon2.  Apricus' product candidate for the treatment of Raynaud's phenomenon, RayVa™, is expected to begin a phase 2a clinical trial in the second half of 2014.

Richard Pascoe, Chief Executive Officer of Apricus, commented, "Apricus is dedicated to advancing our lead therapeutic candidate for RP - RayVa - that we believe could provide relief to the many scleroderma patients who also have secondary RP.  I speak for all of us at the Company in noting how excited we are to partner with the Scleroderma Research Foundation, an esteemed organization that has made and continues to make great strides in seeking treatments for scleroderma."

"The Scleroderma Research Foundation has built a broad collaborative program with leading researchers, institutions and companies that are advancing our understanding of the disease and therapeutic developments to meet the needs of our community," said Luke Evnin, Ph.D., Chairman of the Scleroderma Research Foundation.  "We are excited to welcome Apricus to the SRF family and believe that Apricus offers a unique perspective and approach to addressing a key symptom - Raynaud's phenomenon - experienced by many individuals with scleroderma." 

About Scleroderma

The word scleroderma means hard skin, but the disease is much more - often affecting the internal organs with life-threatening consequences.  Scleroderma is considered a rare autoimmune disease and has one of the highest mortality rates of the rheumatic diseases.  Women comprise 80% of the patient population with typical onset between the ages of 30 and 50.  Scleroderma is characterized by widespread vascular abnormalities, immune dysregulation and fibrotic complications affecting multiple organs including the skin and lung.  The disease is not contagious or directly hereditary and scientists are still searching for possible causes.  There is no known cure and current therapies address various symptoms rather than truly arresting disease progression.

About The Scleroderma Research Foundation

The Scleroderma Research Foundation is America's leading nonprofit investor in scleroderma research.  It was founded in San Francisco in 1987 by scleroderma patient Sharon Monsky who lost her battle to the disease in 2002.  Monsky's legacy lives on through the organization, chaired by Luke Evnin, Ph.D., a scleroderma patient and managing partner of MPM Capital, a dedicated investor in life sciences.

The foundation's collaborative approach is guided by a world-class Scientific Advisory Board and is empowering scientists from leading institutions to work together to develop an understanding of how scleroderma begins, how it progresses and what can be done to slow, halt or reverse the disease process.

For more information, call 1-800-441-CURE or visit www.sclerodermaRESEARCH.org.

About Raynaud's Phenomenon

Raynaud's phenomenon is characterized by vasoconstriction in the hands, feet or other extremities, resulting in reduced blood flow and the sensation of pain, which can become severe. It is classified as either primary or secondary.  Primary Raynaud's phenomenon, which is not associated with an underlying medical condition, refers to vasoconstriction associated with exposure to cold or stress.  Primary Raynaud's phenomenon affects an estimated 3-5% of the US population, mostly women.3 Secondary Raynaud's phenomenon, with symptoms similar to primary Raynaud's phenomenon, is driven by an underlying medical condition, such as scleroderma, lupus or rheumatoid arthritis.4  There are an estimated 100,000 adult patients with scleroderma in the US1, 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  There is currently no approved therapy for Raynaud's phenomenon in the United States, representing an unmet medical need.

If you have been diagnosed with Raynaud's phenomenon secondary to scleroderma and would like more information about an upcoming clinical trial, please contact us at trials@apricusbio.com for more information.  

About RayVa™

RayVa is a product candidate for the treatment of Raynaud's phenomenon.  RayVa combines alprostadil, a vasodilator, with Apricus' proprietary permeation enhancer DDAIP.HCl, and is applied as an on-demand topical cream to affected extremities.  The U.S. Food and Drug Administration (FDA) has cleared the Company's Investigational New Drug (IND) application for RayVa, allowing the Company to initiate clinical testing.  The Company expects to commence a Phase 2a clinical trial and begin enrollment in the second half of 2014.

About Apricus Biosciences, Inc.

Apricus Biosciences, Inc. ( APRI ) is a pharmaceutical company focused on the development and commercialization of novel therapeutics for men's and women's health.  The Company's lead product, Vitaros®, for the treatment of erectile dysfunction, is approved in Europe and Canada and will be commercialized by Apricus' marketing partners, which 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.  The Company's second-generation Vitaros room temperature device is under development and is expected to enhance the product's commercial value.  RayVa™, the Company's product candidate for the treatment of Raynaud's phenomenon, recently received FDA clearance to begin clinical studies.  The Company intends to begin a Phase 2a trial with RayVa in the second half of 2014.  Femprox®, the Company's product candidate for the treatment of female sexual interest/arousal disorder, has successfully completed an approximately 400-subject proof-of-concept study.  The Company is currently seeking a strategic partner for Femprox.

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: references to the timing of the commencement of a Phase 2a clinical trial for RayVa™, the size of the commercial opportunity for RayVa and the ability to build a focused commercial organization 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 the Company, including, but not limited to: its ability to further develop its product candidate RayVa for the treatment of Raynaud's phenomenon, as well as the timing of such events; Apricus' ability to carry out clinical studies for RayVa, as well as the timing and success of the results of such studies; Apricus' ability to raise additional funding that it may need to continue to pursue its commercial and business development plans; Apricus' ability to obtain the requisite governmental approvals for RayVa; 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 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 at www.sec.gov or without charge from the Company.

1 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).

2 4 Pope JE. The Diagnosis and Treatment of Raynaud's Phenomenon. Drugs 2007; 67: 517-525.

3 Wigley FM. Raynaud's phenomenon. N Engl J Med. 2002; 347:1001-1008. Pope JE. The Diagnosis and Treatment of Raynaud's Phenomenon. Drugs 2007; 67: 517-525. 

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.

CONTACT: Steve MartinApricus Biosciences
         Chief Financial Officer
         ir@apricusbio.com
         (858) 222-8041

         Angeli Kolhatkar
         Burns McClellan
         Senior Vice President
         akolhatkar@burnsmc.com
         (212) 213-0006

Source: Apricus Biosciences, Inc.

This article appears in: News Headlines

Referenced Stocks: APRI


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