Vitaros alprostadil regulatory update
Apricus said Ireland and the Netherlands approved Vitaros alprostadil to treat erectile dysfunction (ED) but Swissmedic recommended against approval based on quality-related issues. Swissmedic said there was insufficient data on the targeted shelf life of the product's cold chain formulation. The company said it plans to appeal the opinion within 30 days. Vitaros now has national approvals in 4 European countries, including Sweden and the U.K. In June, Vitaros was approved under the Europe's decentralized procedure. The Netherlands acted as the reference state and France, Germany, Italy, the U.K., Ireland, Spain, Sweden, Belgium and Luxembourg were concerned member states. Vitaros said it expects to receive the remainder of the approvals through 1Q14. Apricus also said it plans to complete its partnering process for Vitaros for the remaining unpartnered territories in Europe, Latin America and North Africa in 4Q13. The product is a topical prostaglandin E1 (PGE1) cream formulated with Apricus' NexACT transdermal delivery technology. ...