DGAP-News: Apricus Biosciences Provides Vitaros(R) Swissmedic Update

DGAP-News: Apricus Biosciences Provides Vitaros(R) Swissmedic Update

Apricus Biosciences, Inc. 

29.08.2013 22:15
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SAN DIEGO, 2013-08-29 22:15 CEST (GLOBE NEWSWIRE) --
Apricus Biosciences, Inc. ('Apricus Bio' or the 'Company') (Nasdaq:APRI)
(www.apricusbio.com), today announced that Swissmedic, the Agency for
Therapeutic Products in Switzerland, has recommended against approval of
marketing authorization for Vitaros(r) for the treatment of erectile dysfunction
('ED') based on certain quality related issues. Vitaros(r) is currently approved
in Europe through the European Decentralized Procedure ('DCP') and in Canada as
a first line treatment for ED. 

In rendering their decision, Swissmedic informed Apricus Bio that the
previously submitted pre-clinical and clinical data were satisfactory and would
likely support an approval. However, the Agency also noted that the data
provided by the Company pertaining to the targeted shelf life of the product's
cold chain formulation was insufficient to support the approvability of
Vitaros(r) at this time.  The Company intends to submit an appeal regarding this
decision within thirty days. 

'While we remain pleased that the safety and efficacy assessment of our
pre-clinical and clinical data package supports the approval of Vitaros(r), we
believe that we have sufficient grounds for an appeal, which we intend to
pursue,' said Richard Pascoe, Chief Executive Officer of Apricus Bio. 
'Moreover, we will continue to concentrate our efforts on obtaining additional
DCP national phase approvals for Vitaros(r), supporting the product's launch in
the major European markets, and securing additional partnerships in available
territories. We look forward to working closely with Swissmedic toward the goal
of making Vitaros(r) available to ED patients across all of Europe.' 

The Company recently announced that, subsequent to DCP approval, Vitaros(r) has
now received national phase approvals in Ireland, the Netherlands, Sweden and
the United Kingdom.  The Company continues to work independently, as well as
with its commercialization partners, to obtain country-by-country national
phase approvals in the remaining CMS territories including France, Germany,
Italy, Spain, Belgium and Luxembourg. Once the national phase approvals are
secured on a country-by-country basis, marketing of Vitaros(r) can then be
initiated in each country by Apricus Bio's commercialization partners. 

About Vitaros(r)

Vitaros(r) has been approved for the treatment of Erectile Dysfunction ('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 erectile dysfunction and an ED market size of approximately $1 billion in
revenue in Europe alone, Vitaros(r) represents a major market opportunity for
Apricus Bio 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
innovative treatments that 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 Bio's marketing partners, which include Abbott
Laboratories Limited, Takeda Pharmaceuticals International GmbH, Hexal AG
(Sandoz), and Bracco SpA.  Femprox(r), the Company's product candidate for the
treatment of female sexual interest and arousal disorder, has successfully
completed a nearly 400-subject proof-of-concept study. 

For further information on Apricus Bio, 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, its ability to further develop its product
Vitaros(r) for erectile dysfunction, and product candidate Femprox(r) for Female
Sexual Interest and 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,
Switzerland 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. 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 Bio 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
Phone:        
Fax:          
E-mail:       
Internet:     
ISIN:         US9901429525
WKN:          
 
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