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Apricus Biosciences Announces Year-End 2014 Update and 2015 Plans to Advance Its Clinical Pipeline and Further Commercialize Its Erectile Dysfunction Drug Vitaros(R)

SAN DIEGO, Dec. 22, 2014 (GLOBE NEWSWIRE) -- Apricus Biosciences, Inc. (Nasdaq:APRI), a biopharmaceutical company advancing innovative medicines in urology and rheumatology, today reviewed its 2014 corporate progress and its clinical development and commercialization plans for 2015.

Apricus' 2014 Accomplishments

  • Successful European launch of Vitaros®, Apricus' novel topical treatment for erectile dysfunction (ED);
  • Completion of development of the Vitaros Room Temperature Device (RTD) required to begin stability testing;
  • Diversification and strengthening of Apricus' product pipeline, including the recent acquisition of US rights to fispemifene for urological conditions in men, and the initiation of Phase 2a testing of RayVa™ for Raynaud's phenomenon;
  • Enhancement of Apricus' Senior Management Team and Board; and
  • Recast the Company's risk profile by modifying its development priorities and prudently managed funding options to support its strategy.

"2014 has been a transformational year for Apricus. Importantly, we achieved several key corporate goals that will support our growth strategy in 2015 and beyond," said Richard Pascoe, Chief Executive Officer. "We expanded and diversified our drug development pipeline with the in-licensing of fispemifene, an investigational treatment for urological conditions in men, that is in Phase 2 development. We initiated a Phase 2a clinical trial for RayVa, our product candidate for the circulatory disorder Raynaud's phenomenon. In addition, through our partners, Vitaros, our topical treatment for erectile dysfunction, was commercially launched in Europe. The Vitaros launch has been proceeding well, with double-digit growth in monthly prescription activity and positive trends in repeat usage."

Mr. Pascoe added, "We also assembled a focused and highly experienced senior management team that is well positioned to execute on our strategy and operating plans. These new executives joined Apricus because they see the potential to create substantial value by advancing our pipeline and building a strategically diversified company. I am confident that this accomplished team has the drive, incentive and passion to achieve business success and create shareholder value."

"With this solid base of accomplishments, we enter 2015 with a strong portfolio of commercial and development-stage assets. Anticipated 2015 milestones across our programs should reinforce and build investor interest and confidence in Apricus' vision throughout next year," said Mr. Pascoe.

2014 Management Team Enhancements

Neil Morton joined Apricus in March as Vice President, Business Development from Auxilium Pharmaceuticals, where he helped build a pipeline of men's health products including the male erectile dysfunction treatment Stendra. Since joining Apricus, Mr. Morton played an instrumental role in the Company's in-licensing of fispemifene.

Earlier this month, Brian Dorsey was appointed Chief Development Officer bringing to Apricus over 20 years of direct experience in manufacturing, drug development and regulatory leadership, which includes securing FDA approval for the sleep maintenance drug Silenor®.

Last week, Dr. Barbara Troupin joined Apricus as Chief Medical Officer to lead the Company's clinical development efforts. Dr. Troupin most recently held leadership positions in Medical Affairs and Clinical Development at Vivus, where she was the clinician lead for the Phase 3 program for weight loss drug Qsymia®, as well as lead contributor for all medical review of the successful New Drug Application and the lead medical presenter at the FDA Advisory Committee Meeting for this product.

Apricus also plans to appoint a new Vice President of Finance in January. Given Apricus' size, focus on clinical development, and financial reporting needs, Apricus will focus its financial management and reporting responsibilities on this incoming position rather than filling the recently vacated CFO role. The Company's Chief Executive Officer and Chief Medical Officer will lead all investor-facing activities.

While these executive appointments required the departure of several senior executives, Apricus has been successful in forging a smaller, more cost effective and nimble team that possesses the expertise and relevant experience required to execute its refocused mission.

Product and Pipeline Updates

Vitaros

During 2014 Apricus secured European approval, expanded its European distribution partnerships, and the Company's partners initiated commercial launch of Vitaros in four countries: the United Kingdom in June, Germany and Sweden in August and Belgium in November. During 2015, Vitaros is expected to launch in six additional European territories, including major markets such as France, Italy and Spain. The market for ED treatments in Europe represents approximately $1.3 billion in annual sales. Vitaros represents a compelling alternative form of treatment for all ED patients but particularly those that are not using or unable to utilize, for safety reasons, the pill formulations that make up the bulk of ED treatments. Vitaros also provides a more patient-friendly treatment option than injectable or catheter-administered ED medications that generate approximately $100 million in annual sales in Europe.

Apricus' marketing partners for Vitaros are Abbott Laboratories Limited, Takeda Pharmaceuticals International GmbH, Hexal AG (Sandoz), Recordati Ireland Ltd. (Recordati S.p.A.), Bracco S.p.A. and Laboratoires Majorelle.

During the fourth quarter of 2014, Apricus completed the development of the room temperature formulation of Vitaros, which is housed and delivered in a small, custom developed, disposable dispenser or "room temperature device." The initial production of Vitaros RTD to generate the required stability data required for marketing approval has commenced. The Company continues to expect its commercial partners to launch the Vitaros RTD in 2016.

Fispemifene

During the fourth quarter of 2014, Apricus in-licensed the U.S. rights to fispemifene from Forendo Pharma. Fispemifene is an exciting new chemical entity with solid Phase 2 data that builds upon the Company's male urological focus. The first indication being pursued for fispemifene is for the treatment of secondary hypogonadism in males. Apricus believes fispemifene targets at least $1 billion of the total market for current therapies that currently generate over $2 billion in annual sales. The Company plans to begin a Phase 2b clinical trial with fispemifene in this lead indication in the first half of 2015, with top-line data expected to be reported by the end of 2015. Since in-licensing fispemifene, Apricus has transferred the regulatory filings from Forendo, developed the Phase 2b clinical trial protocol, held a scientific advisory board meeting with leading experts in the field to refine our development strategy, initiated the manufacturing process to obtain drug product, and begun the clinical trial site selection process.

RayVa

Patient enrollment commenced in December 2014 for a 45-patient Phase 2a clinical trial for RayVa, Apricus' internally developed product candidate for Raynaud's phenomenon, a circulatory disorder affecting the hands and feet. Patients are being actively screened and enrolled for this trial, which is expected to be completed and results announced in the second quarter in 2015. Apricus believes RayVa's market potential could approach $200 million in annual sales, as it would be the only FDA approved treatment for this debilitating condition.

Femprox

In consultation with its clinical and regulatory experts, Apricus decided earlier this year to put on hold the development of its female sexual interest / arousal disorder product candidate Femprox, until such time as the regulatory pathway becomes more certain and a more robust partnering environment develops. This decision reflects both the anticipated costs of development and the current development risks related to such an investment.

Goals and Priorities for 2015 and Beyond

1) Apricus will continue to leverage Vitaros as a cash-generating asset through growing royalty and milestone payments as the Company's commercial partners ramp up sales and expand the product's market reach via additional European launches. Apricus will also continue to pursue out-license opportunities for Vitaros in Asia Pacific and Latin America and will work to support the launch of Vitaros by its distribution partner in Canada.

2) Apricus plans to complete Phase 2 clinical trials for RayVa and fispemifene in 2015 and report RayVa Phase 2a study results by the end of the second quarter of 2015 and fispemifene Phase 2b study results in the fourth quarter of 2015. Positive results from these trials, if achieved, would further demonstrate these drug candidates' therapeutic and commercial potential and position Apricus to move these assets into Phase 3 clinical trials, when appropriate.

3) Apricus will seek to fund operations and the continued development of these projects via cost-effective, shareholder-friendly means. Funding sources include ongoing cash flows from Vitaros' commercialization, pursuit of additional out-licensing agreements for Vitaros, RayVa and Femprox, and accessing equity or debt funding or strategic investments as market conditions allow, in addition to the prudent management of expenses and existing cash. Apricus will continue to be disciplined stewards of shareholder capital, advancing projects only when the Company has determined that the cost of capital and the potential upside are aligned with shareholders' interests.

Mr. Pascoe concluded, "This year, the Board of Directors and I have made crucial decisions on our strategic priorities and capital allocation, with a goal of maximizing the future potential of Apricus while prudently managing risk. We recognize the challenges our shareholders have faced over the past year; however, we are confident that progress in our growth plan during 2015 will create the momentum needed to build sustained shareholder value."

"I would like to thank our employees and partners for their hard work and commitment to execution of key goals for 2014. Through their collective efforts, I am confident we will succeed in 2015. Finally, I want to thank our investors for their patience and their efforts to embrace the new strategies and underlying rationale we have employed to focus Apricus on the most compelling development opportunities from a return on investment and risk management standpoint. Their support and persistence is genuinely appreciated."

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 is being 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™, its product candidate for the treatment of the circulatory disorder Raynaud's phenomenon. Additionally, Apricus plans to initiate a Phase 2b trial for fispemifene, a selective estrogen receptor modulator for the treatment of male secondary hypogonadism, chronic prostatitis and lower urinary tract symptoms. Apricus is currently seeking a strategic partner to fund development of Femprox®, a product candidate for the treatment of female sexual interest/arousal disorder that completed an approximately 400-subject proof-of-concept study.

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 expected increase in sales of Vitaros® and royalty revenues from the sale of Vitaros in various countries by Apricus' commercial partners; the planned launch for Vitaros in new European countries and Canada; the timing of Phase 2 clinical trials for fispemifene and RayVa and an approved pathway for RayVa and fispemifene and the timing of top-line data for fispemifene; the size of the commercial opportunity for Vitaros, RayVa and fispemifene and the potential for such products to achieve commercial success; the planned out-license of Vitaros in Asia Pacific and Latin America and the potential out-license of Femprox®; the potential to raise debt or equity funding or access strategic investments; the planned hiring of a Vice President of Finance; the ability of Apricus' management team to execute its strategy and successfully carry out planned development programs for the room temperature version of Vitaros, fispemifene and RayVa and Apricus' 2015 financial outlook. 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: its ability to further develop its product Vitaros for the treatment of erectile dysfunction, such as the room temperature version of Vitaros, and its product candidates RayVa for the treatment of Raynaud's phenomenon and fispemifene for the treatment of secondary hypogonadism, chronic prostatitis and lower urinary tract symptoms in men, as well as the timing of such events; Apricus' ability to carry out clinical studies for RayVa and fispemifene, as well as the timing and success of the results of such studies; potential adverse side effects or other safety risks associated with fispemifene and RayVa that could delay or preclude approval; Apricus' dependence on its commercial partners to increase sales of Vitaros in various territories, and the potential for delays in the timing of commercial launches in additional countries; competition in the erectile dysfunction market and other markets in which Apricus and its partners operate; Apricus' ability to obtain license partners for Vitaros, Femprox and RayVa; Apricus' ability to obtain and maintain intellectual property protection for Vitaros, RayVa, fispemifene or any other product candidates; Apricus' ability to raise additional funding that it may need to continue to pursue its commercial and business development plans; Apricus' ability to draw the second term loan under the credit facility when expected, or at all, including Apricus' failure to meet the conditions required to draw under the loan and security agreement; Apricus' ability to remain in compliance with the terms and restrictions under the credit facility; Apricus' ability to access additional capital under the equity facility; Apricus' ability to obtain the requisite governmental approval for the room temperature version of Vitaros, RayVa, fispemifene and Femprox; 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.

CONTACT: 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.