Apricus Biosciences Announces Approval of Vitaros® for the Treatment of Erectile Dysfunction in Mexico
January 18 2017 - 7:00AM
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™, 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.
CONTACT:
Matthew Beck
mbeck@troutgroup.com
The Trout Group
(646) 378-2933
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