DGAP-News: Apricus Biosciences, Inc. /
Apricus and Recordati Sign Exclusive License Agreement to Market
Topical Erectile Dysfunction Cream - Vitaros(R) in Spain, Russia,
Turkey and Other Global Territories
10.02.2014 / 13:00
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Apricus Eligible to Receive Up to Approximately $50 Million in Upfront and
Milestone Payments, Plus Double-Digit Tiered Royalties
SAN DIEGO, 2014-02-10 13:00 CET (GLOBE NEWSWIRE) --
Apricus Biosciences, Inc. ('Apricus' or the 'Company') (Nasdaq:APRI)
(www.apricusbio.com), today announced it has signed an exclusive license
agreement with Recordati S.p.A. ('Recordati') (Bloomberg REC IM) to market
Vitaros(r), its topical on-demand product for the treatment of erectile
dysfunction ('ED'), in Spain, Russia, Turkey, Ireland and certain other
European and African countries (the 'Territory').
Under the terms of the agreement, Apricus is eligible to receive up to
approximately $3.8 million from Recordati in upfront and pre-commercialization
milestone payments. Apricus is also eligible to receive up to approximately $47
million in sales milestone payments, plus double-digit tiered royalties based
on Recordati's net sales of the product in the Territory. In exchange,
Recordati will have the exclusive right to commercialize Vitaros(r) in the
Territory, which covers a number of countries and regions including Spain,
Russia, Turkey, Ireland, Portugal, Greece, Cyprus, Bulgaria, Croatia, Czech
Republic, Estonia, Hungary, Latvia, Lithuania, Poland, Romania, Slovakia,
Slovenia, Armenia, Azerbaijan, Belarus, Kazakhstan, Kyrgyzstan, Moldova,
Tajikistan, Turkmenistan, Uzbekistan, Ukraine, Georgia and certain African
countries. Recordati has agreed to obtain all necessary regulatory approvals at
its sole cost.
'We look forward to building a long-term relationship with Recordati in support
of their efforts to introduce the first and only topical on-demand treatment
for erectile dysfunction in these valuable markets,' said Richard Pascoe, Chief
Executive Officer of Apricus. 'This agreement, which marks the completion of
our Vitaros(r) licensing efforts in Europe, reflects our continued commitment to
commercializing Vitaros(r) through leading pharmaceutical companies such as
Recordati in an effort to bring this best in class erectile dysfunction
treatment to patients in 2014.'
Vitaros(r) is partnered in key markets, including with Takeda in the UK, Sandoz
in Germany, Switzerland and certain countries in Northern Europe, Bracco in
Italy, Majorelle in France, Monaco and certain African countries, Recordati in
Spain, Russia, Turkey, Ireland and certain other European and African
countries, and Abbott in Canada. The Company's existing commercialization
partners are currently preparing for Vitaros(r) product launches in their
respective territories with product launches expected throughout 2014.
About Vitaros(r)
Vitaros(r) is approved for the treatment of ED by a number of European health
authorities and by Health Canada. Vitaros(r) is a topically-applied cream
formulation of alprostadil, a vasodilator, combined with our proprietary
permeation enhancer DDAIP.HCl, which directly increases blood flow to the
penis, causing an erection. Alprostadil is a widely accepted alternative to the
PDE-5 inhibitors for difficult to treat patients, and Vitaros(r), which was
determined to be safe and effective by the European health authorities and
previously by Health Canada, offers greater market opportunity due to its
patient-friendly form versus other alprostadil dosage forms and also relative
to oral ED products. With nearly 150 million men worldwide who suffer from ED
and an ED market size of approximately $1 billion in revenue in Europe alone,
Vitaros(r) represents a major market opportunity for Apricus and its commercial
partners given its unique product profile and its potential to treat a large
underserved population.
About Recordati S.p.A.
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 cardiovascular and urogenital therapeutic areas 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 pharmaceutical company that develops and
markets through its licensing partners innovative treatments that have the
potential to help large patient populations across numerous, large-market
therapeutic classes including male and female sexual health. The Company has
one approved product, Vitaros(r), for the treatment of erectile dysfunction,
which is now approved in Europe and Canada and will be commercialized by
Apricus' marketing partners, which include Abbott Laboratories Limited, Takeda
Pharmaceuticals International GmbH, Hexal AG (Sandoz), Recordati S.p.A., Bracco
SpA and Laboratoires Majorelle. Femprox(r), the Company's product candidate for
the treatment of female sexual interest/arousal disorder, has successfully
completed a nearly 400-subject proof-of-concept study.
For further information on Apricus, visit http://www.apricusbio.com.
Apricus' 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, its ability to further develop its product
Vitaros(r) for ED, such as the room temperature version of Vitaros(r) and
product
candidate Femprox(r) for female sexual interest/arousal disorder among others;
to
have its product and product candidates receive additional patent protection
and be approved by relevant regulatory authorities in Europe, the United
States, Canada and in other countries, such as additional national phase
approvals for Vitaros(r) in the remaining CMS territories, Spain and Luxembourg;
to successfully commercialize such product and product candidates and other
NexACT(r) product candidates and drug delivery technology; and to achieve its
other development, commercialization and financial goals, such as successfully
manufacturing and launching Vitaros(r) in partnered territories. 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, as amended, subsequent
quarterly reports filed on Form 10-Q, as amended, 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 Investor Relations:
David Pitts or Lourdes Catala
Argot Partners
212-600-1902
david@argotpartners.com
lourdes@argotpartners.com
News Source: NASDAQ OMX
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Language: English
Company: Apricus Biosciences, Inc.
United States
ISIN: US9901429525
End of News DGAP News-Service
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251847 10.02.2014
DGAP-News: Apricus and Recordati Sign Exclusive License Agreement to Market Topical Erectile Dysfunction Cream - Vitaros(R) in Spain, Russia, Turkey and Other Global Territories
| Source: EQS Group AG