Continued Commercial Expansion in Europe Expected to Increase
Royalty Revenue for Apricus
SAN DIEGO, Sept. 21, 2016 (GLOBE
NEWSWIRE) -- Apricus Biosciences, Inc. (Nasdaq:APRI), a
biopharmaceutical company advancing innovative medicines in urology
and rheumatology, today announced the launch of Vitaros®,
Apricus' novel on-demand topical cream for the treatment of
erectile dysfunction (ED), in the Czech Republic and Slovakia by
Recordati.
Richard Pascoe, Chief Executive
Officer of Apricus, commented, "We are pleased to announce the
launch of Vitaros in these important ED markets by our partner
Recordati. With these launches, Vitaros is now commercially
available in nine European countries. Moreover, we expect
additional approvals and product launches later this year and early
next year by our commercialization partners. Looking forward,
our key strategic goals continue to be achieving profitability
through Vitaros revenue growth and obtaining Vitaros FDA approval
in the United States in 2017."
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 $39.7 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 an alternative for patients, but
particularly those with complications that preclude them from using
the orally delivered systemic treatments or who prefer to avoid the
injectable forms of alprostadil.
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 Europe, part of
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), 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; the potential for the product to achieve
commercial success generally or in any specific territory,
including the Czech Republic and Slovakia, and 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' 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 obtain additional product approvals; 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; Apricus' ability to negotiate and
enter into acceptable terms for new licensing agreements; 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