DGAP-News: Apricus Biosciences, Inc. /
Apricus Expands Exclusive License Agreement With Its Partner in
Germany to Market Vitaros(R) in Additional European Countries

16.12.2013 / 13:01

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Apricus Eligible to Receive Up to $63 Million in Combined Upfront, Regulatory,
Launch and Sales Milestone Payments, Plus Double-Digit Tiered Royalties 

SAN DIEGO, 2013-12-16 13:00 CET (GLOBE NEWSWIRE) --
Apricus Biosciences, Inc. ('Apricus' or the 'Company') (Nasdaq:APRI)
(www.apricusbio.com), announced today that it has expanded its exclusive
license agreement with Hexal AG, an affiliate within the Sandoz Division of the
Novartis Group of Companies ('Sandoz'), for the commercialization of Vitaros(r),
indicated for the treatment of patients with erectile dysfunction ('ED'). In
addition to the in-place collaboration in Germany, this expanded agreement now
includes Austria, Belgium, Denmark, Finland, Iceland, Luxemburg, the
Netherlands, Norway, Sweden and Switzerland (the 'Expanded Territory'). 

In combination with the previously signed license agreement for Germany,
Apricus is now eligible to receive up to approximately $63 million from Sandoz
in upfront, regulatory, launch and sales milestone payments for Vitaros(r) in
Germany and the Expanded Territory, which includes up to $4.5 million in new
upfront and launch milestone compensation for the Expanded Territory. 

'This expanded commercialization agreement with Sandoz accomplishes one of our
key corporate objectives - the expansion of an existing Vitaros(r) partnership
in 
Europe,' said Richard Pascoe, Chief Executive Officer of Apricus. 'We are
pleased with the strong working relationship we have with Sandoz and we look
forward to supporting their team as they bring this novel, topical, on-demand
ED treatment option to physicians and patients throughout Northern Europe.' 

Vitaros(r) was approved in Europe under the Decentralized Procedure ('DCP') in
June 2013.  Since then, the product has received six national phase approvals
in Europe, including Germany, Ireland, Italy, the Netherlands, Sweden and the
United Kingdom.  Apricus continues to work independently, as well as with its
license partners, to obtain country-by-country national phase approvals in the
remaining CMS territories, including France, Spain, Belgium and Luxembourg. 
The Company's regulatory efforts, along with actions taken by its existing
European license partners, are on track to obtain the remaining four European
approvals during the fourth quarter of 2013 and the first quarter of 2014. 

Vitaros(r) is currently licensed to Takeda in the United Kingdom, Sandoz in
Germany, Austria, Benelux and the Nordics, Bracco in Italy, Laboratoires
Majorelle in France, Monaco and certain Africa countries, and Abbott in Canada. 

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, Sandoz International GmbH, 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 and guidance on
approval of Femprox(r); 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 Austria, Benelux and the Nordics. 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               
 
 
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