DGAP-News: Apricus Biosciences and Neopharm Group Sign Licensing Agreement for Vitaros(R) in Israel for up to $4.35 Million, Plus Royalties
ID: 348169
14.02.2011 16:14
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SAN DIEGO, 2011-02-14 16:14 CET (GLOBE NEWSWIRE) --Apricus Biosciences, Inc. ('Apricus Bio') (Nasdaq:APRI), announced today that
it has entered into a licensing agreement granting Neopharm Group ('Neopharm')
the exclusive rights to market and sell Vitaros(r), Apricus Bio's treatment for
erectile dysfunction ('ED') and, when and if available, its formulation for the
treatment of premature ejaculation ('PE'), in Israel and the Palestinian
Territories of the Gaza Strip and the West Bank.
On November 12, 2010, Apricus Bio announced that Health Canada had approved
Vitaros(r) for marketing as the first topical treatment for ED in that country.
The application for approval to market Vitaros(r) for ED in Israel is scheduled
to be filed in the first half of 2011 and later, in the Palestinian
Territories.
Under the terms of the licensing agreement, Neopharm has been granted exclusive
rights in Israel and the Palestinian Territories to commercialize and market
Vitaros(r) under the Vitaros(r) trademark for ED and, when and if available,
Apricus Bio's formulation for PE. In return, Apricus Bio is entitled to receive
up to a total of $4.35 million in up-front, regulatory and sales milestone
payments for the products. Further, over the life of the agreement, Apricus Bio
will receive tiered, double-digit royalties based on Neopharm's sales of the
products.
Commenting on today's announcement, Dr. Bassam Damaj, President and Chief
Executive Officer of Apricus Bio, stated, 'We are delighted to be able to
announce yet another licensing and commercialization agreement for our first
product, Vitaros(r), that utilizes our proprietary NexACT(r) technology. Since
December 22, 2010, we have closed three licensing and commercialization
transactions covering 14 countries. We also continue to talk with numerous
other potential partners to increase the number of these transactions and to
broaden the potential market for Vitaros(r).'
David Fuhrer, Chairman of the Neopharm Group, commented, 'I am confident that
our well established expertise and heritage in partnership with innovative
biopharmaceutical companies will make Vitaros(r) a success in Israel. We see
Vitaros(r) as an excellent addition to our group's strong and growing portfolio
of innovative products.'
About Vitaros(r) and the ED Market
According to Neopharm, the ED market in Israel and the Palestinian Territories
is dominated by oral PDE5 treatments. However, there is still a need for new,
safe and effective treatments, especially for those patients who cannot or do
not respond well to oral medication. Vitaros(r) differs from oral PDE5 drugs like
Viagra(r), Cialis(r) and Levitra(r) in two ways. First, it is applied directly to the
penis as a cream, instead of as a pill that is absorbed systemically. The
topical application helps to reduce side effects and enables men who cannot
take, or do not do well with the existing drugs, to have a patient-friendly
alternative.
Second, Vitaros(r) operates by a different biochemical mechanism than oral ED
medications, and causes erections to occur in a more localized fashion and more
quickly when compared to oral treatments. Vitaros(r) contains a previously
marketed ED drug, known by the chemicalname of alprostadil. When absorbed
through the skin, alprostadil, a vasodilator, directly boosts blood flow,
thereby causing an erection. Clinical studies have shown that Vitaros(r) works on
average in approximately 15 minutes, compared to a reported onset time of 30
minutes or more for oral medications indicated for the treatment of ED. The
side effects reported were localized and transient.
Alprostadil is currently marketed as an injectable drug. Apricus Bio
incorporated alprostadil with its NexACT(r) delivery technology, resulting in a
rapid and efficient topical delivery of the drug into the penis. In clinical
studies, Vitaros(r) worked in patients suffering from mild to severe ED,
including men who did not respond to Viagra(r). Viagra(r) is a registered trademark
of Pfizer, Inc.; Cialis(r) is a registered trademark of Lilly, USA; Levitra(r), is
a registered trademark of Bayer A.G.; Vitaros(r) is a registered trademark in
Israel held by Apricus Bio through its subsidiary NexMed International Limited,
and in the U.S. held by Warner Chilcott Company.
About Neopharm Group
Established in 1941, Neopharm Group is one of Israel's leading providers of
innovative integrated solutions across the pharmaceutical, medical and
healthcare markets. Neopharm has a long heritage of collaboration with leading
multinational corporations and is positioned as the partner-of-choice and
one-stop-shop for multinational corporations seeking to enter or expend their
business in the Israeli healthcare market. The group has expertise and
strengths in marketing of pharmaceuticals and biological products including
niche and orphan drugs, hospital products, vaccines, medical devices,
diagnostic products, medical and scientific equipment, OTC/CH products, medical
services and home therapy - all of which enabled the group to grow and become
the second largest provider to the Israeli healthcare market with annual
revenues exceeding $300M, and 600 employees. The Neopharm Group is
headquartered in Petach Tiqva, Israel. www.neopharmisrael.com
About Apricus Biosciences, Inc.
Apricus Bio, a San Diego based revenue-generating pharmaceutical company, has
leveraged the flexibility of its clinically-validated NexACT(r) drug delivery
technology to enable multi-route administration of new and improved compounds
across numerous therapeutic classes. Future growth is expected to be driven
through out-licensing of this technology for the development and
commercialization of such compounds to pharmaceutical and biotechnology
companies, worldwide, as well as by monetizing its existing product pipeline,
including its approved drug erectile dysfunction treatment, Vitaros(r), in
addition to compounds in development from pre-clinical through Phase III,
currently focused on Sexual Dysfunction, Oncology, Dermatology, Autoimmune,
Pain, Anti-Infectives, Diabetes and Cosmeceuticals, among others. For further
information on Apricus Bio and its subsidiaries, visit
http://www.apricusbio.com
Apricus Bio's Forward-Looking Statement Safe Harbor
Statements under the Private Securities Litigation Reform Act, as amended: with
the exception of the historical information contained in this release, the
matters described herein contain forward-looking statements that involve risks
and uncertainties that may individually or mutually impact the matters herein
described for a variety of reasons that are outside the control of the Company,
including, but not limited to, timing for seeking foreign approvals for
Vitaros(r) for erectile dysfunction and for a chemical formulation similar to
Vitaros(r) for premature ejaculation, timing and success of the commercial launch
of Vitaros(r) in Italy, The Gulf Countries and part of the Middle East and in
Israel and the Palestinian Territories, the potential size of the market, the
ability to develop and commercialize the Company's products on its own and with
partners and the ability to meet its milestones. Readers are cautioned not to
place undue reliance on these forward-looking statements as actual results
could differ materially from the forward-looking statements contained herein.
Readers are urged to read the risk factors set forth in the Company's 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 or without charge from the Company.
CONTACT: Apricus Biosciences, Inc.
Edward Cox, V.P.
Investor Relations&Corporate Development, Apricus Bio, Inc.
(858) 848-4249
ecox@apricusbio.com
Apricus Bio Investor Relations
Paula Schwartz
Rx Communications Group, LLC
(917) 322-2216
pschwartz@rxir.com
Neopharm Group, Israel
bd@neopharmisrael.com
+972 3 9373783
Uri Goren,
Spokesman and PR Manager
uri.g@neopharmgroup.com
+972-52-7444680
News Source: NASDAQ OMX
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Company: Apricus Biosciences, Inc.
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ISIN: US9901429525
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