Apricus Biosciences Offers Year-End '14 Update; in '15 Plans to Advance Clinical Pipeline, Further Commercialization of ED Drug Vitaros(R)

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Apricus Biosciences, Inc.
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."
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