Italy should be a good market for Vitaros. Good PR.
Vitaros(R) on Track for European Launch in 2014
Additional Vitaros(R) Partnerships Expected in 4Q 2013
SAN DIEGO, Nov. 25, 2013 (GLOBE NEWSWIRE) -- Apricus Biosciences, Inc. ("Apricus" or the "Company") (APRI) (www.apricusbio.com), today announced that the Italian Medicines Agency (AIFA) has granted national phase approval to Vitaros(R), indicated for the treatment of patients with erectile dysfunction ("ED"). The Company has now received a total of six national phase approvals for Vitaros(R), including Germany, Ireland, Italy, the Netherlands, Sweden and the United Kingdom ("UK") following its broad approval by European health authorities in June 2013.
"We look forward to working with Bracco, our commercialization partner in Italy, as they prepare for a successful launch of the
first topical, on-demand treatment for erectile dysfunction in this key European market," said Richard Pascoe, Chief Executive Officer of Apricus. "Our regulatory efforts remain on track to obtain the remaining four European national phase approvals during the fourth quarter of 2013 and first quarter of 2014. Looking forward, our top priorities are to secure additional Vitaros(R) partnerships and support our commercialization partners' launch preparations in Europe. We expect to announce one or more additional Vitaros(R) partnerships this quarter and anticipate the rollout of multiple Vitaros(R) launches across Europe in 2014."
In June 2013, Apricus announced that its marketing application for Vitaros(R) was approved through the European Decentralized Procedure ("DCP"). Under the DCP, Apricus filed its application for marketing approval designating the Netherlands as the Reference Member State ("RMS") on behalf of nine other European Concerned Member States ("CMS") participating in the procedure. The Company continues to work toward obtaining country-by-country national phase approvals in the remaining CMS territories including France, Spain, Belgium and Luxembourg. Once the national phase approvals are secured on a country-by-country basis, marketing of Vitaros(R) can then be initiated in each country by Apricus' commercialization partners.
Once launched, Vitaros(R) will become the first new and novel ED product in nearly a decade, and with its unique product profile that addresses a large number of patients who cannot or do not respond well to the existing therapies, or who are intolerant to the systemic effects of PDE-5 inhibitors, it is well-positioned for commercial success. In Europe alone, the existing ED products generated over $1 billion in sales in 2012. Apricus believes that a significant portion of the market remains untreated or under-treated, which represents a substantial commercial opportunity for Vitaros(R).
Vitaros(R) is currently partnered in key markets, including with Takeda in the United Kingdom, Sandoz in Germany, Bracco in Italy, Majorelle in France, Monaco and certain African countries, and Abbott in Canada. The Company's existing commercialization partners are preparing for Vitaros(R) product launches in their respective territories.
