National Phase Approvals Granted In Ireland And The Netherlands For Apricus Biosciences' (APRI) Vitaros

Aug. 16, 2013 2:04 PM ETSEEL
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Pharmaceutical company Apricus Biosciences announced that both the Irish Medicines Board and the Netherlands' Medicines Evaluation Board have granted national phase approvals for Vitaros. Indicated to treat patients with erectile dysfunction, Vitaros is a topically applied cream formulation of alprostadil, a vasodilator, combined with DDAIP.HCL, which is Apricus Bio's proprietary permeation enhancer.

The company has received four national phase approvals so far for Vitaros - from Ireland, the Netherlands, Sweden, and the United Kingdom. In June of this year, the company announced its marketing application for the product had been approved through the European Decentralized Procedure (DCP). Apricus Bio filed its application for marketing approval under the DCP, designating Netherlands as the reference member state (RMS) on behalf of nine other European concerned member states (CMS) that were taking part in the procedure. Apricus Bio continues working both independently and with its commercialization partners to obtain national phase approvals on a country-by-country basis in the remaining CMS territories, including France, Germany, Italy, Spain, Belgium, and Luxembourg. Once these country-by-country national phase approvals have been secured, marketing of Vitaros can be commenced in each country by Apricus Bio's commercialization partners.

Currently, Vitaros is partnered in key markets with companies that include Takeda in the U.K., Sandoz in Germany, Bracco in Italy, and Abbott in Canada. A comprehensive partnering process was recently launched by Apricus Bio with the aim of licensing Vitaros in the remaining un-partnered territories in Europe, Latin America, and North Africa. Recently received bids from multiple interested parties for the available territories are currently being reviewed, and the company anticipates the Vitaros partnering process will be completed in the fourth quarter of 2013.

Once it has been launched, Vitaros will become the first new and novel erectile dysfunction product to be released in almost a decade. It is well-positioned for commercial success due to its unique profile, which addresses numerous patients who cannot or do not respond well to current therapies or who are intolerant to the systematic effects of PDE5 inhibitors. Existing erectile dysfunction products generated more than $1 billion in 2012 sales in Europe alone. Apricus Bio believes a substantial portion of the market remains as yet untreated or undertreated - which means a considerable commercial opportunity for Vitaros.

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