Vitaros ® on Track for European Launch in 2014 Company Provides Femprox ® Update Company to Host Conference Call/Webcast Today at 9:00 AM ET
- 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.Financial Status 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.