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2016-09-08

Apricus Biosciences Announces Approval of Vitaros® for the Treatment of Erectile Dysfunction in Argentina

Apricus Biosciences, Inc.
Press release

Apricus Biosciences Announces Approval of Vitaros® for the Treatment of
Erectile Dysfunction in Argentina

First Vitaros Approval in Latin America, Registrations Also Filed in Mexico and
Colombia

SAN DIEGO, 2016-09-08 13:00 CEST (GLOBE NEWSWIRE) --
Apricus Biosciences, Inc. (Nasdaq:APRI), a biopharmaceutical company advancing
innovative medicines in urology and rheumatology, today announced that
Argentina 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-fourth country in which the product has been approved,
including Austria, Belgium, Canada, Czech Republic, Denmark, Finland, France,
Germany, Iceland, Ireland, Italy, Lebanon, Luxembourg, the Netherlands, Norway,
Poland, Portugal, Romania, Slovakia, Spain, Sweden, Switzerland and the United
Kingdom.

“We are very pleased that Vitaros has received its first approval in Latin
America,” said Richard Pascoe, Chief Executive Officer of Apricus. “This
approval, along with the registration filings in Mexico and Columbia, marks an
important milestone for Apricus as we seek to build a global Vitaros brand. I
want to congratulate our colleagues at Ferring for their efforts in building
the Vitaros franchise in major markets throughout Europe and Latin America, and
we look forward to Ferring obtaining additional regulatory approvals and
driving revenue through additional product launches this year and next.”

Earlier this 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 Europe, the
Middle East and Canada and is being commercialized in several countries in
Europe. 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 S.p.A.), 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.

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 Argentina 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

Författare SSE

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