Apricus Biosciences Announces Approval of Vitaros® for the Treatment of Erectile Dysfunction in Mexico
(Thomson Reuters ONE) -
Ferring Plans to Launch in Mexico and Argentina During the Second Quarter 2017
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.
CONTACT:
Matthew Beck
mbeck(at)troutgroup.com
The Trout Group
(646) 378-2933
This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: Apricus Biosciences, Inc. via GlobeNewswire
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Bereitgestellt von Benutzer: hugin
Datum: 18.01.2017 - 13:00 Uhr
Sprache: Deutsch
News-ID 518422
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