This Day On The Street
Continue to site right-arrow
ADVERTISEMENT
This account is pending registration confirmation. Please click on the link within the confirmation email previously sent you to complete registration.
Need a new registration confirmation email? Click here
Stocks Under $10 with 50-100% upside potential - 14 days FREE!

Apricus Biosciences Receives European Approval For Vitaros(R) For The Treatment Of Erectile Dysfunction

Stocks in this article: APRI

SAN DIEGO, June 10, 2013 (GLOBE NEWSWIRE) -- Apricus Biosciences, Inc. ("Apricus Bio" or the "Company") (Nasdaq:APRI) ( http://www.apricusbio.com ), today announced that its marketing application for Vitaros ®, indicated for the treatment of patients with erectile dysfunction ("ED"), has been approved through the European Decentralized Procedure ("DCP").

"The approval of Vitaros ® in Europe marks a significant milestone for Apricus Bio as we continue to execute on our core strategy of developing, seeking regulatory approval, and partnering our sexual health products," said Richard Pascoe, Chief Executive Officer of Apricus Bio. "Vitaros ® has a unique product profile that meets the needs of a large number of patients suffering from erectile dysfunction and who are intolerant to or do not respond to current treatment options.  With its rapid onset of action and unique topical delivery, we believe that Vitaros ® will capture a significant share of the approximately $1 billion PDE-5 inhibitor market in Europe once it is launched by our commercial partners."

"Moreover, partnering interest in Vitaros ® remains strong and we are actively seeking to secure additional partnerships in the remaining European and global markets," continued Pascoe. "With the completion of a $17.1 million financing, the divestiture of multiple non-core assets, and streamlining of our global operations in the second quarter of 2013, Apricus Bio is now well positioned to advance our lead assets for male and female sexual health, Vitaros ® and Femprox ®, in an effort to create long-term shareholder value."

Under the DCP, Apricus Bio filed its application for marketing approval designating Netherlands as the Reference Member State ("RMS") on behalf of nine other European Concerned Member States ("CMS") participating in the procedure. The CMS include France, Germany, Italy, UK, Ireland, Spain, Sweden, Belgium and Luxembourg. The Company will continue to work independently as well as with its commercialization partners, Sandoz, Takeda, and Bracco for the next step of obtaining national phase approvals in order to make Vitaros ® ready to launch in each of the included territories across Europe.

Conference Call Information

The call will take place today, June 10 at 9:00 AM ET and can be accessed in the U.S. by dialing 877-407-9210 and outside of the U.S. by dialing 201-689-8049 and asking the conference operator for the Apricus Bio Conference Call. The conference call will also be webcast live at www.investorcalendar.com/IC/CEPage.asp?ID=171060 . The teleconference replay will be available for three months by dialing in the U.S. 877-660-6853 and outside of the U.S. by dialing 201-612-7415. Replay Passcode 415699 is required for playback. The webcast replay will be available for three months.

About Vitaros ®

Vitaros ® 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 ®, 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 a market affecting nearly 150 million men worldwide and representing approximately $1 billion in revenue in Europe, Vitaros ® represents a major market opportunity, particularly as a distinct product that addresses a significant underserved population.

About Femprox ®

Femprox ® is our product candidate for the treatment of female sexual arousal disorder (FSAD) which contains a topically-applied cream formulation of alprostadil, a vasodilator, and our proprietary permeation enhancer DDAIP.HCL. Seven clinical studies have been successfully completed to date, including one, 98-subject Phase 2 study in the US and a nearly 400-subject Phase 3 study in China. To date, no product has been approved in the U.S. to treat FSAD, a persistent or recurring inability to attain or maintain adequate sexual excitement, causing personal distress. Estimates of the FSAD market size put it on par with erectile dysfunction in males, and possibly larger.

About Apricus Biosciences, Inc.

Apricus Biosciences, Inc. (APRI) is a pharmaceutical company that develops and markets 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 ®, 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 Canada, Takeda Pharmaceuticals International GmbH, Sandoz, and Bracco SpA.  Femprox ®, the Company's product candidate for the treatment of female sexual arousal disorder, has successfully completed a nearly 400-subject Phase 3 study in China.

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 ® for erectile dysfunction , and product candidate Femprox ® for Female Sexual 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 and Canada and in other countries; to successfully commercialize such product and product candidates and other NexACT ® product candidates and drug delivery technology; to sell its oncology supportive care business or assets to a third party or parties; to cease funding to its French subsidiaries and to have such subsidiaries reorganize or liquidate successfully; 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

Apricus logo

Check Out Our Best Services for Investors

Action Alerts PLUS

Jim Cramer and Stephanie Link reveal their investment tactics while giving advanced notice before every trade.

Product Features:
  • $2.5+ million portfolio
  • Large-cap and dividend focus
  • Intraday trade alerts from Cramer
Quant Ratings

Access the tool that DOMINATES the Russell 2000 and the S&P 500.

Product Features:
  • Buy, hold, or sell recommendations for over 4,300 stocks
  • Unlimited research reports on your favorite stocks
  • A custom stock screener
Stocks Under $10

Jim Cramer's protégé, David Peltier, uncovers low dollar stocks with extraordinary upside potential that are flying under Wall Street's radar.

Product Features:
  • Model portfolio
  • Stocks trading below $10
  • Intraday trade alerts
Try it NOW
Try it NOW
Try it NOW

Check Out Our Best Services for Investors

Dividend Stock Advisor

Jim Cramer's protégé, David Peltier, identifies the best of breed dividend stocks that will pay a reliable AND significant income stream.

Product Features:
  • Diversified model portfolio of dividend stocks
  • Updates with exact steps to take - BUY, HOLD, SELL
Trifecta Stocks

Every recommendation goes through 3 layers of intense scrutiny—quantitative, fundamental and technical analysis—to maximize profit potential and minimize risk.

Product Features:
  • Model Portfolio
  • Intra Day Trade alerts
  • Access to Quant Ratings
Options Profits

Our options trading pros provide over 100 monthly option trading ideas and strategies to help you become a well-seasoned trader.

Product Features:
  • Actionable options commentary and news
  • Real-time trading community
Try it NOW
Try it NOW
Try it NOW
To begin commenting right away, you can log in below using your Disqus, Facebook, Twitter, OpenID or Yahoo login credentials. Alternatively, you can post a comment as a "guest" just by entering an email address. Your use of the commenting tool is subject to multiple terms of service/use and privacy policies - see here for more details.
Submit an article to us!

Markets

DOW 17,650.96 -21.64 -0.12%
S&P 500 2,050.54 -1.28 -0.06%
NASDAQ 4,755.8670 -2.0120 -0.04%

Partners Compare Online Brokers

Free Reports

Free Newsletters from TheStreet

My Subscriptions:

After the Bell

Before the Bell

Booyah! Newsletter

Midday Bell

TheStreet Top 10 Stories

Winners & Losers

Register for Newsletters
Top Rated Stocks Top Rated Funds Top Rated ETFs