Vitaros® on Track for European Launch in 2014
Company Provides Femprox® Update
Company to Host Conference Call/Webcast Today at 9:00 AM ET
SAN DIEGO, Nov. 13, 2013 (GLOBE NEWSWIRE) -- Apricus Biosciences, Inc. ("Apricus" or the "Company") (Nasdaq:APRI) (www.apricusbio.com), today provided a third quarter corporate update, including clinical, commercial and regulatory strategies for its topical on-demand product Vitaros® for erectile dysfunction ("ED") and its product candidate Femprox® for female sexual interest/arousal disorder ("FSIAD").
"Since the beginning of 2013, we have focused on the successful execution of our corporate goals, including gaining European regulatory approval for Vitaros®, licensing the un-partnered Vitaros® territories in Europe, obtaining regulatory feedback from the FDA on Femprox® and streamlining our business," said Richard Pascoe, Chief Executive Officer of Apricus. "We continue to make progress on each of these fronts, including obtaining an approval for Vitaros® in Europe through the Decentralized Procedure ("DCP"), advancing our partnering discussions to include licensing Vitaros® to Laboratoires Majorelle in France, Monaco and Africa, obtaining regulatory advice from the FDA on Femprox®, strengthening our balance sheet, and completing the divestiture of all non-strategic assets. Looking forward, our top priorities are to secure additional Vitaros® partnerships and support our commercialization partners' launch preparations for Vitaros®. We expect to announce one or more additional Vitaros® partnerships this quarter and anticipate the rollout of multiple Vitaros® launches across Europe in 2014."
Mr. Pascoe continued: "Regarding Femprox®, we received clear regulatory guidance from the FDA in August 2013, and together with our Scientific Advisory Board, have drafted a clinical development plan for Femprox® in the U.S. Given the recent DCP approval of Vitaros® in Europe, and the fact that Femprox® contains a unique concentration of the same active ingredient and novel proprietary permeation enhancer as Vitaros®, we believe there may be a streamlined path to approval in Europe for Femprox®. Therefore, we have requested a meeting with the European regulatory authorities to confirm whether a more rapid development path for Femprox® is possible in Europe. We expect this meeting to occur in the first quarter of 2014. Additionally, we are awaiting the outcome of an approval decision by the FDA for a competitive female sexual dysfunction product that we believe will help us further refine the Femprox® development strategy. With a well-defined U.S. regulatory path in hand, and with expected near term visibility on two critical pieces of regulatory feedback, we believe that shareholder interest will best be served by advancing Femprox® into the clinic with a development partner which we intend to pursue in early 2014."
- Launch Preparations Underway. Vitaros® was approved in Europe under the DCP in June 2013. Since then, Apricus, or its commercialization partners, have received five national phase approvals in Europe, including Germany, Ireland, the Netherlands, Sweden and the United Kingdom ("UK"). Apricus continues to work independently, as well as with its partners, to obtain country-by-country national phase approvals in the remaining CMS territories including France, Spain, Belgium, Italy and Luxembourg. The Company's regulatory efforts, along with actions taken by its existing European partners, are on track to obtain the remaining five European approvals. The Company has received commercial product orders from its commercialization partners and manufacturing activities have commenced for both sample and commercial product to support the expected Vitaros® launch in Europe. In addition, our existing partners in Europe continue to prepare for an expected commercial launch in their respective territories in 2014.
- Partnering Initiative Remains on Track. In June 2013, Apricus launched a comprehensive partnering process with the goal of licensing Vitaros® in the remaining un-partnered territories in Europe, and the Emerging Markets, including, Russia, Turkey, Latin America and Africa. The Company's key partnering objectives for Vitaros® are to maximize the total deal value for the asset, expand existing Vitaros® partnerships wherever possible, and select partners who have a strong clinical, regulatory and commercial presence in the respective territory. In addition to today's announcement that we entered into a partnership with Laboratoires Majorelle in France, Monaco and Africa, Apricus has received and reviewed multiple bids for the available territories, has narrowed the number of potential partners to a select group, and is negotiating with multiple parties. The Company expects to complete negotiations and announce one or more new Vitaros® partnerships in the fourth quarter of 2013.
- Room Temperature Device and Other Manufacturing Initiatives Progressing. Apricus continues to make progress with its next-generation, room temperature version of Vitaros®. This new version is expected to have a targeted shelf life of at least 24 months and will not require refrigeration. The Company has contracted with an additional manufacturing partner that will serve as a second source of global supply for Vitaros®. The Company expects this second manufacturing site, located in Canada, will be ready to supply cold chain Vitaros® product to its commercialization partners in the second half of 2014. The site will also serve as the primary manufacturing site for the ongoing room temperature Vitaros® development program. Apricus believes this next-generation, room temperature version will be a key driver of Vitaros® market growth and expansion in 2015 and beyond.
- Integrating Guidance from U.S. and European Health Authorities. Apricus completed an End-of-Phase II meeting with the U.S. Food and Drug Administration ("FDA") in late August 2013. In written guidance received from the FDA following the meeting, the Agency concurred that the proposed indication of FSIAD can be pursued in both pre- and post-menopausal women, but that efficacy in each group must be demonstrated separately. The FDA also concurred with the Company's proposed dosage levels, clinical endpoints of Satisfying Sexual Events (SSE) and the arousal domain of the female sexual function index ("FSFI"), and certain other study design details. The Agency guided that a future study of Femprox® should incorporate endpoints that would be used to validate the arousal domain of FSFI. In addition, the FDA also stated that no additional non-clinical studies, other than a reproductive and developmental assessment, would be required to support a New Drug Application ("NDA"). The Company recently met with its Scientific Advisory Board and has developed a draft clinical development program for Femprox® in the U.S.
The Company believes there may be a more streamlined path to approval in Europe for Femprox®. Therefore, Apricus is seeking regulatory guidance for Femprox® from the European regulatory authorities and expects to meet to gain insight from the authorities in the first quarter of 2014. Moreover, the Company, along with its Scientific Advisors, believes that it is essential to understand the outcome of a pending approval decision for a competitive female sexual dysfunction product by the FDA prior to finalizing the Femprox® clinical development program and initiating any potential partnering activities. Therefore, the Company plans to provide an update in early 2014 following its analysis of these two critical items.
Cash and cash equivalents totaled $20.6 million as of September 30, 2013, compared to $15.1 million as of December 31, 2012. Based upon our current business plan, the Company believes it has sufficient cash reserves to fund its ongoing operations through 2014. The Company filed its third quarter 2013 financial results with the U.S. Securities and Exchange Commission on November 12, 2013.
Conference Call Information
The call can be accessed in the U.S. by dialing 877-407-9210 and outside of the U.S. by dialing 201-689-8049 and asking the conference operator for the Apricus Conference Call. The conference call will also be webcast live at: http://www.investorcalendar.com/IC/CEPage.asp?ID=171856. The teleconference replay will be available for one week by dialing in the U.S. 877-660-6853 and outside of the U.S. by dialing 201-612-7415. Replay Passcode 13572631 is required for playback. The webcast replay will be available for three months.
Vitaros® has been approved for the treatment of ED by the European Health Authorities and by Health Canada. Vitaros® is a topically-applied cream formulation of alprostadil, a vasodilator, combined with our proprietary permeation enhancer DDAIP.HCl, which directly increases blood flow to the penis, causing an erection. Alprostadil is a widely accepted alternative to the PDE-5 inhibitors for difficult to treat patients, and Vitaros®, which was determined to be safe and effective by the European Health Authorities and previously by Health Canada, offers greater market opportunity due to its patient-friendly form versus other alprostadil dosage forms and also relative to oral ED products. With nearly 150 million men worldwide who suffer from ED and an ED market size of approximately $1 billion in revenue in Europe alone, Vitaros® represents a major market opportunity for Apricus and its commercial partners given its unique product profile and its potential to treat a large underserved population.
Femprox® is a product candidate for the treatment of FSIAD. Seven clinical studies have been successfully completed to date, including one, 98-subject Phase II study in the US and a nearly 400-subject proof-of-concept study in China. To date, no product has been approved in the U.S. to treat FSIAD, a persistent or recurring inability to attain or maintain adequate sexual excitement, causing personal distress.
About Apricus Biosciences, Inc.
Apricus Biosciences, Inc. (APRI) is a pharmaceutical company that develops and markets through its licensing partners, innovative treatments that have the potential to help large patient populations across numerous, large-market therapeutic classes including male and female sexual health. The Company has one approved product, Vitaros®, for the treatment of erectile dysfunction, which is now 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), Bracco SpA and Laboratoires Majorelle. Femprox®, the Company's product candidate for the treatment of female sexual interest/arousal disorder, has successfully completed a nearly 400-subject proof-of-concept study.
For further information on Apricus, visit http://www.apricusbio.com.
Apricus' Forward-Looking Statement Safe Harbor
Statements under the Private Securities Litigation Reform Act, as amended: 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 further develop its product Vitaros® for ED, such as the room temperature version of Vitaros®, and product candidate Femprox® for female sexual interest/arousal disorder among others; to have its product and product candidates receive additional patent protection and be approved by relevant regulatory authorities in Europe, the United States, Canada and in other countries, such as additional national phase approvals for Vitaros® in the remaining CMS territories and guidance on approval of Femprox®; to successfully commercialize such product and product candidates and other NexACT® product candidates and drug delivery technology; and to achieve its other development, commercialization and financial goals, including the manufacture and launch of Vitaros®. 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, as amended, subsequent quarterly reports filed on Form 10-Q, as amended, and other filings made with the SEC. Copies of these reports are available from the SEC's website or without charge from the Company.
Source:Apricus Biosciences, Inc.