Apricus Biosciences Announces Approval of Vitaros(R) for the Treatment of Erectile Dysfunction in Lebanon
(Thomson Reuters ONE) -
SAN DIEGO, July 27, 2016 (GLOBE NEWSWIRE) -- Apricus Biosciences, Inc.
(Nasdaq:APRI), a biopharmaceutical company advancing innovative medicines in
urology and rheumatology, today announced that the Republic of Lebanon Ministry
of Public Health has granted market approval to Vitaros(®), a topical cream
indicated for the treatment of patients with erectile dysfunction. Apricus has
an exclusive license agreement with Elis Pharmaceuticals ("Elis") for the
commercialization of Vitaros in the United Arab Emirates, Oman, Bahrain, Qatar,
Saudi Arabia and Kuwait (the "Gulf States") and part of the Middle East.
This is the twenty-third country in which the product has been approved,
including Austria, Belgium, Canada, Czech Republic, Denmark, Finland, France,
Germany, Iceland, Ireland, Italy, 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 the Middle
East," said Richard Pascoe, Chief Executive Officer of Apricus. "Moreover, we
look forward to Elis' launch of Vitaros in Lebanon, and additional launches this
year by other commercial partners in countries where the product has been
approved, but is not currently marketed."
In January 2011, Apricus signed an exclusive license agreement with Elis to
market Vitaros in the Gulf States and part of the Middle East, including
Lebanon, Syria, Jordan, Iraq and Yemen. Under the terms of the agreement,
Apricus has received an upfront payment of $100,000 from Elis. Apricus is
eligible to receive a regulatory milestone payment of $100,000 as the result of
this approval, which the Company expects to receive this quarter, as well as up
to $1.9 million in milestone payments on future sales, plus tiered double-digit
royalties in the low to high teens based on Elis' net sales of the product.
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 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 the timing
of planned launches of Vitaros(®) in various countries by Apricus' commercial
partners 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 Lebanon and other territories and the potential for delays in the
timing of commercial launch; 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.
Matthew Beck
mbeck(at)troutgroup.com
The Trout Group
(646) 378-2933
This announcement is distributed by GlobeNewswire on behalf of
GlobeNewswire clients. The owner of this announcement warrants that:
(i) the releases contained herein are protected by copyright and
other applicable laws; and
(ii) they are solely responsible for the content, accuracy and
originality of the information contained therein.
Source: Apricus Biosciences, Inc. via GlobeNewswire
[HUG#2030879]
Unternehmensinformation / Kurzprofil:
Datum: 27.07.2016 - 13:00 Uhr
Sprache: Deutsch
News-ID 485701
Anzahl Zeichen: 5566
contact information:
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Kategorie:
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