Apricus Biosciences, Inc. has filed its response to questions received from Swissmedic, the Agency for Therapeutic Products in Switzerland, relating to its marketing application previously filed for its lead product candidate Vitaros, for the treatment of erectile dysfunction (ED) in Switzerland.
The filing of the Apricus Bio response triggers a 90-day review process, after which if found acceptable, may then trigger a pre-decision by Swissmedic for the approval of Vitaros for ED in that country. Following a subsequent approval decision and any required company responses, Apricus Bio would then be required to supply Swissmedic with the final labeling and pricing information of Vitaros, which could take an additional 90 days for review and acceptance before that product can be marketed in Switzerland.
“An approval in Switzerland would mark our second worldwide approval and our first European approval for Vitaros for ED and would be an important step for us in our goal of marketing and selling this product on a worldwide basis,” said Bassam Damaj, PhD, president and chief executive officer of Apricus Bio. “Swissmedic is considered one of the most well-respected health regulatory agencies in the world, and their decisions influence the regulatory decisions in many other countries.”
Apricus is currently in discussions with multiple potential commercial partners for Vitaros for ED in Switzerland.
According to IMS Health, the annual ED market in Switzerland was estimated to be €27 million in 2010. Switzerland is not part of the European Union and is therefore not regulated by the European Medicines Agency. Marketing drugs in Switzerland requires an independent application and approval from Swissmedic. Marketing applications for Vitaros have also been filed in the European Union and in the MENA territories.
Apricus Bio has received approval for Vitaros as a first-line treatment for ED in Canada, where the company's partner, Abbott Laboratories Limited, plans to launch the product in that country in the second half of 2012. In addition to Canada, partnership and licensing agreements for Vitaros have been executed by Apricus Bio in the US, Germany, Italy, certain Middle East and North African (MENA), the Gulf countries and Israel.
Vitaros is a topically delivered formulation of alprostadil delivered using Dodecyl 2-N, N-(dimethylamino)-propionate hydrochloride (DDAIP HCl), the Company's proprietary NexACT drug delivery technology, for the treatment of erectile dysfunction (ED). When absorbed through the skin, alprostadil, a vasodilator, directly boosts blood flow, thereby causing an erection.
Vitaros differs from oral medications in two ways. First, it is applied locally, directly to the penis as a cream, instead of administered orally and thus is not absorbed systemically. This topical application helps to reduce side effects and provides men who cannot take the existing oral medications a patient-friendly alternative. Second, clinical studies have shown that Vitaros works on average in approximately 15 minutes, compared to a reported onset time of 30 minutes, or longer, for oral medications.
Apricus Bio is a revenue-generating pharmaceutical company, with commercial products and a broad pipeline across numerous therapeutic classes.