SAN DIEGO, Jan. 18, 2017 (GLOBE
NEWSWIRE) -- Apricus Biosciences, Inc. (Nasdaq:APRI), a
biopharmaceutical company advancing innovative medicines in urology
and rheumatology, today announced that Mexico has granted Apricus'
commercialization partner, Ferring Pharmaceuticals, market approval
for Vitaros®, an on-demand topical cream indicated for the
treatment of patients with erectile dysfunction.
This is the twenty-sixth country
in which the product has been approved, including Argentina,
Austria, Belgium, Canada, Czech Republic, Denmark, Finland, France,
Germany, Greece, Iceland, Ireland, Italy, Lebanon, Luxembourg, the
Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Spain,
Sweden, Switzerland and the United Kingdom.
"We are very pleased that Ferring
has received its second approval for Vitaros in Latin America,"
said Richard Pascoe, Chief Executive Officer of Apricus. "Moreover,
we look forward to Ferring's launches of Vitaros in Latin America
throughout the year, in addition to the portfolio of countries
across the EU they have the rights to as well. Again,
congratulations to the Ferring team for their continued commitment
to building the Vitaros global brand."
Last year, the Company expanded
its exclusive Vitaros distribution agreement with Ferring in Latin
America to include Germany, Austria, Belgium, Denmark, Finland,
Iceland, Luxembourg, Norway, the Netherlands, Sweden, Switzerland
and certain countries in Asia (previously Sandoz's territories),
the United Kingdom (previously Takeda's territory) and Korea.
Under the terms of the agreement, Apricus has received a total of
$4.5 million in upfront payments from Ferring, in addition to a
regulatory milestone payment of $1.6 million. Apricus is
eligible to receive up to an additional $28 million in regulatory,
launch and sales milestones, plus royalties on future net
sales.
About
Apricus Biosciences, Inc.
Apricus Biosciences, Inc. (APRI)
is a biopharmaceutical company advancing innovative medicines in
urology and rheumatology. Apricus' commercial product, Vitaros®*,
for the treatment of erectile dysfunction, is approved in Canada
and certain countries in Europe, Latin America and the Middle East
and is being commercialized in certain countries in Europe and the
Middle East. In September 2015, Apricus in-licensed the U.S.
development and commercialization rights for Vitaros from Allergan.
Apricus' marketing partners for Vitaros include Recordati Ireland
Ltd. (Recordati), Ferring International Center S.A. (Ferring
Pharmaceuticals), Laboratoires Majorelle, Bracco S.p.A., Mylan NV
and Elis Pharmaceuticals Ltd. Apricus currently has one
active product candidate, RayVa(TM), its product candidate for the
treatment of the circulatory disorder Raynaud's phenomenon.
For further information on Apricus,
visit http://www.apricusbio.com.
*Vitaros® is a registered
trademark of NexMed International Limited. Such trademark is
registered in certain countries throughout the world and pending
registration in the United States.
Forward Looking
Statements
This press release contains
forward-looking statements within the meaning of the Private
Securities Litigation Reform Act, as amended. Statements in this
press release that are not purely historical are forward-looking
statements. Such forward-looking statements include, among other
things: references to potential Vitaros approvals and product
launches by Apricus' commercial partners in additional countries
and the timing thereof; and the potential for Apricus to receive
future milestone and royalty revenue. Actual results could differ
from those projected in any forward-looking statements due to a
variety of reasons that are outside of Apricus' control, including,
but not limited to: Apricus' ability to have its product Vitaros be
approved by relevant regulatory authorities in additional
countries; Apricus' dependence on its commercial partners to carry
out the commercial launch of Vitaros in Mexico and other
territories and the potential for delays in the timing of
commercial launch; Apricus' ability to obtain and maintain
intellectual property protection for the product; Apricus' ability
to raise additional funding that it may need to continue to pursue
its commercial and business development plans; competition in the
ED market and other markets in which Apricus and its partners
operate; and market conditions. These forward-looking statements
are made as of the date of this press release, and Apricus assumes
no obligation to update the forward-looking statements, or to
update the reasons why actual results could differ from those
projected in the forward-looking statements. Readers are urged to
read the risk factors set forth in Apricus' most recent annual
report on Form 10-K, subsequent quarterly reports filed on Form
10-Q, and other filings made with the SEC. Copies of these reports
are available from the SEC's website at www.sec.gov or
without charge from Apricus.