Apricus Biosciences Announces Approval of Vitaros® for the Treatment of Erectile Dysfunction in Argentina
(Thomson Reuters ONE) -
First Vitaros Approval in Latin America, Registrations Also Filed in Mexico and
Colombia
SAN DIEGO, Sept. 08, 2016 (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((TM)), 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(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
Unternehmensinformation / Kurzprofil:
Datum: 08.09.2016 - 13:00 Uhr
Sprache: Deutsch
News-ID 493596
Anzahl Zeichen: 6189
contact information:
Town:
SAN DIEGO
Kategorie:
Business News
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