DGAP-News

Apricus Biosciences Provides First Quarter 2013 Corporate Update - Seite 2

interruptions in the review process. If Vitaros(r) is approved by the RMS,
our commercialization partners will commence with the National Phase
approvals in their respective territories. Once those approvals are secured
on a country-by-country basis, marketing of Vitaros(r) can then be initiated
in each country by our commercialization partners. In Europe, existing ED
products generated over $1 billion in sales in 2012 and Apricus Bio
believes that a significant portion of the market remains untreated or
undertreated, which represents a significant commercial opportunity for
Vitaros(r).
-- Commercial Launch of Vitaros(r) in Canada. Vitaros(r) is approved in Canada,
and Apricus Bio licensed Vitaros(r) to Abbott Canada for commercialization of
the product in that territory. Abbott remains fully committed to a
successful launch of the cold-chain version of Vitaros(r) in Canada in the
shortest timeframe possible. Abbott is working with their contract
manufacturer to optimize the product's shelf-life period, which is driven
by specifications that are applicable only to the product that will be sold
in Canada, prior to launching the product in that market. As a result of
these ongoing developments, Abbott has confirmed that a Vitaros(r) launch in
Canada in the first half of 2013 will not occur.
-- Femprox(r) Development Program: Femprox(r) is our lead product candidate for
the treatment of female sexual arousal disorder, or FSAD. To date, we have
completed seven clinical studies with Femprox(r) including a 100 patient
Phase 2 study in the U.S. and a 400 patient Phase 3 study in China. The
data generated from these studies strongly suggests that Femprox(r) has the
potential to effectively treat FSAD in a female patient population where
there are currently no available FDA approved treatment options. Moreover,
we believe that Femprox(r) could be the first and only on-demand treatment
approved for FSAD, where estimates of the market size are on par with that
found in the erectile dysfunction market. The Company continues to advance
the Femprox(r) development program in close consultation with our clinical
and regulatory advisors. Our near-term goal is to seek confirmatory
regulatory guidance from the U.S. FDA in the form of an End-of-Phase 2
meeting.
-- Divestiture of Non-Core Assets: The Company sold its product, Totect(r)
(dexrazoxane HCl), a marketed, injectable treatment for anthracycline