Apricus Biosciences, Inc. (Nasdaq:APRI), a biopharmaceutical
company advancing innovative medicines in urology and rheumatology,
today announced that Greece has granted Apricus’ commercialization
partner, Recordati, market approval for Vitaros®, an on-demand
topical cream indicated for the treatment of patients with erectile
dysfunction.
This is the twenty-fifth country in which the
product has been approved, including Argentina, 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 Recordati has received
another Vitaros approval within its territory. Recordati continues
to aggressively expand the Vitaros brand in Europe with commercial
efforts ongoing in six countries,” said Richard Pascoe, Chief
Executive Officer of Apricus. “For the remainder of this year and
into 2017, we will continue to focus on growing Vitaros revenue
through licensing and new launches, seeking Vitaros U.S. regulatory
approval and managing our expenses in an effort to achieve
profitability.”
In February 2014, Apricus signed an exclusive
license agreement with Recordati to market Vitaros in Spain,
Russia, Turkey, Ireland and certain other European and African
countries and received an upfront payment of $2.4 million.
Under the terms of the agreement, Apricus is eligible to receive up
to approximately $38.6 million from Recordati in additional
milestones, plus double-digit tiered royalties in the ten to twenty
percent range based on Recordati’s net sales of the product in the
territory.
Vitaros is a new entrant into these ED treatment
markets, offering a product profile making it appealing to certain
patients. Vitaros is a topical ED cream that delivers rapid
onset (generally five to thirty minutes) and treatment duration of
approximately one to two hours. Vitaros’ local delivery provides a
first line alternative to oral treatment. In addition to patients
who prefer topical treatment as their first treatment option,
patients with complications that preclude them from using orally
delivered systemic treatments can benefit from Vitaros.
About Recordati
Established in 1926, Recordati is an
international pharmaceutical group, listed on the Italian Stock
Exchange (Bloomberg REC IM), with a total staff of around 4,000,
dedicated to the research, development, manufacturing and marketing
of pharmaceuticals. Recordati is headquartered in Milan, Italy,
with operations in the main European countries, in Russia, in other
Central and Eastern European countries, in Turkey, in the United
States of America and in North Africa. An efficient field force of
medical representatives promotes a wide range of innovative
pharmaceuticals, both proprietary and under license, in a number of
therapeutic areas including a specialized business dedicated to
treatments for rare diseases. Recordati is a partner of choice for
new product licenses for its territories. Recordati is committed to
the research and development of new drug entities within the
urogenital therapeutic area and of treatments for rare
diseases.
For further information, please visit the
Recordati website: www.recordati.com.
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 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), 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,
including Greece; the potential for the product to achieve
commercial success generally or in any specific territory,
including Greece; the potential for Apricus to receive future
milestone and royalty revenue; the ability of Apricus to achieve
profitability based on Vitaros revenue growth; and the timing of
approval, if any, by the Food and Drug Administration (FDA) of
Vitaros in the United States. 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 or grow sales of Vitaros in various
territories, such as Recordati in its territory, and the potential
for delays in the timing of commercial launches; competition in the
ED market and other markets in which Apricus and its partners
operate; 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; Apricus’ ability to
obtain FDA and other requisite governmental approval for Vitaros;
the fluctuation of currency exchange rates; the potential for
adverse reactions to the product; 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 LLC
(646) 378-2933
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