Vitaros® National Phase Approvals Granted in the United Kingdom and Sweden Company to Host Conference Call/Webcast Today at 9:00 AM ET
- European Approval Decision for Vitaros®. In June 2013, Apricus Bio announced that its marketing application for Vitaros®, indicated for the treatment of patients with erectile dysfunction ("ED"), was approved through the European Decentralized Procedure ("DCP"). Under the DCP, the Company filed its application for marketing approval designating Netherlands as the Reference Member State ("RMS") on behalf of nine other European Concerned Member States ("CMS") participating in the procedure. The CMS includes France, Germany, Italy, UK, Ireland, Spain, Sweden, Belgium and Luxembourg.
- National Phase Approvals Granted in the UK and Sweden. Last week, Apricus Bio was granted national phase approvals for Vitaros® in the UK and Sweden. The Company continues to work independently as well as with its commercialization partners to obtain the country-by-country national phase approvals for the remaining CMS regions. Our regulatory efforts along with the actions taken by our existing European partners continue to move successfully toward making Vitaros® ready to launch in each of the included territories across Europe.
- Vitaros® Partnering Process on Track. Concurrent with the EU approval of Vitaros®in June 2013, Apricus Biolaunched a comprehensive partnering process with the goal of licensing Vitaros® in the remaining un-partnered territories in Europe, Latin America, and North Africa. Our 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 their respective territory. We are reviewing bids recently received from multiple interested parties for the available territories and we expect to complete our Vitaros® partnering process in the fourth quarter of this year.
- Femprox® Development Program. Femprox® is Apricus Bio's lead product candidate for the treatment of female sexual interest/arousal disorder, or FSIAD. An End-of-Phase 2 meeting with the U.S. Food and Drug Administration ("FDA") is currently scheduled for late August 2013. Following receipt of official FDA meeting minutes, Apricus Bio will be able to provide further clarity regarding the Femprox® regulatory pathway in the U.S. To date, the Company has completed seven clinical studies with Femprox® including a 100 patient Phase 2 study in the U.S. and a 400 patient proof of concept study in China. The data generated from these clinical studies strongly suggest that Femprox® has the potential to effectively treat a patient population where there are currently no available FDA approved treatment options.
- Completed $17.1 Million Public Offering. In May 2013, Apricus Bio completed an underwritten public offering of its common stock and warrants for gross proceeds totaling approximately $17.1 million, the net proceeds of which the Company intends to use for general corporate purposes, including various development and approval efforts related to Vitaros® and Femprox®.
- Two Vitaros® Poster Presentations at Scientific Meetings. In May 2013, John P. Mulhall, MD, Director of the Male Sexual and Reproductive Medicine Program at Memorial Sloan-Kettering Cancer Center, presented results from an analysis of existing Phase 3 data for Vitaros® at the American Urological Association Annual Meeting. The results demonstrated that Vitaros® was well tolerated and improved erections in men who were previously unresponsive to PDE-5 inhibitors. In June 2013, the Company presented results from an additional analysis of existing Phase 3 data at the International Symposium on Prostate, Androgens and Men's Sexual Health, which demonstrated increased efficacy and decreased adverse events with longer-term use of Vitaros®.