DGAP-News  820  0 Kommentare Apricus Biosciences Announces National Phase Approval for Erectile Dysfunction Cream - Vitaros(R) in Italy

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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') (Nasdaq: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