DGAP-News: Apricus and Laboratoires Majorelle Sign Exclusive License Agreement to Market Topical Erectile Dysfunction Cream Vitaros(R) in France, Monaco and Certain African Countries
(firmenpresse) - Apricus Biosciences, Inc.
13.11.2013 12:00
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Apricus Eligible to Receive Up to $25 Million in Upfront, Regulatory and Sales
Milestone Payments and Double-Digit Tiered Royalties
SAN DIEGO, 2013-11-13 12:00 CET (GLOBE NEWSWIRE) --
Apricus Biosciences, Inc. ('Apricus' or the 'Company') (Nasdaq:APRI)
(www.apricusbio.com), announced today that Apricus signed an exclusive license
agreement with Laboratoires Majorelle ('Majorelle') to market Vitaros(r), its
topical on-demand product for the treatment of erectile dysfunction ('ED'), in
France, Monaco and certain African countries (the 'Territory').
Under the terms of the agreement, Apricus is eligible to receive up to $4
million from Majorelle in upfront and regulatory milestone payments. Apricus is
also eligible to receive up to approximately $21 million in milestone payments
on future sales, plus double-digit tiered royalties based on Majorelle's net
sales of the product in the Territory. In exchange, Majorelle will have the
exclusive right to commercialize Vitaros(r) in the Territory. In addition,
Majorelle has agreed to minimum marketing commitments for Vitaros(r), including
the expansion of its existing sales force in France.
'Given their extensive depth and experience in the urology market, Majorelle is
well equipped to bring the unique benefits of Vitaros(r) to patients and health
care providers in these important territories,' said Richard Pascoe, Chief
Executive Officer of Apricus. 'With their strong and growing commercial
organization, led by a highly experienced management team, and their impressive
financial commitment to marketing Vitaros(r), we look forward to Majorelle's
successful launch of the only topical on-demand ED treatment in France and
other French speaking countries.'
'We're very excited to have an opportunity to work with Apricus and market
Vitaros(r) in France, Monaco and Africa,' said Majorelle's Chairman, Mehdi El
Glaoui. 'We have a strong urology presence in France, one of the largest ED
markets in Europe, and we are committed to a robust launch of Vitaros(r) with an
experienced team capable of driving sales and expanding the market. With
national phase approval on the horizon, we are well positioned to bring this
best in class ED treatment to patients.'
Vitaros(r) is currently partnered in key markets, including with Takeda in the
United Kingdom, Sandoz in Germany, Bracco in Italy, Majorelle in France, Monaco
and certain African countries, and Abbott in Canada. Apricus has received and
reviewed multiple bids for commercialization rights for Vitaros(r) in the
remaining un-partnered territories in Europe and it expects to announce
additional licensing transactions by year-end 2013.
About Vitaros(r)
Vitaros(r) has been approved for the treatment of ED by the 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 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), 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.
About Laboratoires Majorelle
Laboratoires Majorelle was founded in 2001 and is headquartered in Paris,
France. Majorelle has a strong, well-experienced commercialization team
dedicated to urology and reproductive products for both males and females.
For further information on Majorelle, visit
http://www.laboratoires-majorelle.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 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; 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, including in France. 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(at)argotpartners.com
lourdes(at)argotpartners.com
News Source: NASDAQ OMX
13.11.2013 Dissemination of a Corporate News, transmitted by DGAP -
a company of EQS Group AG.
The issuer is solely responsible for the content of this announcement.
DGAP's Distribution Services include Regulatory Announcements,
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Language: English
Company: Apricus Biosciences, Inc.
United States
Phone:
Fax:
E-mail:
Internet:
ISIN: US9901429525
WKN:
End of Announcement DGAP News-Service
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