Print

Sandoz, Inc. Buys German Rights to Apricus Biosciences (APRI)' Sex Drug for $28 Million  
2/16/2012 7:30:35 AM

SAN DIEGO, Feb 15, 2012 (GlobeNewswire via COMTEX) -- Apricus Biosciences, Inc. ("Apricus Bio" or the "Company") ( http://www.apricusbio.com ) announced today that its wholly-owned subsidiary NexMed(USA), Inc. has signed with Sandoz, a division of Novartis, an exclusive collaboration for Germany to market Apricus Bio's Vitaros(R) drug for the treatment of erectile dysfunction.

Pursuant to the collaboration, Sandoz will pay Apricus Bio up to EURO21 million -- divided into a fixed upfront payment and specific regulatory and commercial milestones -- as well as, double digit royalties on net sales. Total upfront and milestone payments represent approximately $28 million based on today's exchange rate.

Bassam Damaj, Chairman, President and Chief Executive Officer of Apricus Bio commented, "We are very excited about this major European collaboration with such an important international pharmaceutical company as Sandoz. We are happy to work again with Novartis through their division Sandoz and we look forward to expanding the reach of our Vitaros(R) product for erectile dysfunction in Germany. This is yet another important milestone in our strategy to make Vitaros(R) available worldwide and the successful continuation of the execution of our commercialization strategy of Vitaros(R)."

About Vitaros(R) and the ED Market in Europe

The ED market in Europe is presently dominated by oral PDE5 treatments. However, there is still a need for new, safe and effective treatments, especially for those patients who cannot or do not respond well to oral medication. Vitaros(R) differs from oral PDE5 drugs like Viagra(R), Cialis(R) and Levitra(R) in two ways. First, it is applied directly to the penis as a cream, instead of as a pill that is absorbed systemically. The topical application helps to reduce side effects and enables men who cannot take, or do not do well with the existing drugs, to have a patient-friendly alternative.

Second, Vitaros(R) operates by a different biochemical mechanism than oral ED medications, and causes erections to occur in a more localized fashion and more quickly when compared to oral treatments. Vitaros(R) contains a previously known compound, with the chemical name alprostadil. When absorbed through the skin, alprostadil, a vasodilator, directly boosts blood flow, thereby causing an erection. Clinical studies have shown that Vitaros(R) works on average in approximately 15 minutes, compared to a reported onset time of 30 minutes or more for oral medications indicated for the treatment of ED. The side effects reported were localized and transient.

Alprostadil is currently marketed as an injectable drug. Apricus Bio incorporated alprostadil with its NexACT(R) delivery technology, resulting in a rapid and efficient topical delivery of the drug into the penis. In clinical studies, Vitaros(R) worked in patients suffering from mild to severe ED, including men who did not respond to Viagra(R). Viagra(R) is a registered trademark of Pfizer, Inc.; Cialis(R) is a registered trademark of Lilly, USA; Levitra(R), is a registered trademark of Bayer A.G.; Vitaros(R) is a registered trademark in Europe held by Apricus Bio through its subsidiary NexMed International Limited, and in the U.S. held by Warner Chilcott Company.

About Apricus Biosciences, Inc.

Apricus Bio is a San Diego-based, revenue-generating, specialty pharmaceutical company, with commercial products and a broad pipeline across numerous therapeutic classes.

Revenues and growth are driven from the sales of the Company's commercial products through its Apricus Pharmaceuticals USA, Inc. and NexMed (USA), Inc. subsidiaries and through out-licensing in certain territories of its product pipeline and NexACT(R) technology. Apricus Bio currently markets Totect(R)(dexrazoxane HCl), the only drug approved in the US for the treatment of anthracycline extravasation. Apricus Bio's current pipeline includes Vitaros(R), approved in Canada for the treatment of erectile dysfunction, as well as compounds in development from pre-clinical through pre-registration currently focused on Sexual Dysfunction, Oncology, Dermatology, Autoimmune, Pain, Anti-Infectives, Diabetes and Consumer Healthcare.

The Company also expects to develop and/or acquire and then bring to market additional pharmaceutical products in areas of care that will benefit patient needs worldwide.

For further information on Apricus Bio, visit http://www.apricusbio.com , and for information on its subsidiary please visit http://www.nexmedusa.com . You can also receive information at http://twitter.com/apricusbio and http://facebook.com/apricusbio .

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 and their products and product candidates, to have its products and product candidates approved by relevant regulatory authorities, including Europe, to successfully commercialize such NexACT(R) products as Vitaros(R) for erectile dysfunction and product candidates and to achieve its development, commercialization and financial goals with Sandoz in Germany and other countries. 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.

This news release was distributed by GlobeNewswire, www.globenewswire.com

SOURCE: Apricus Biosciences, Inc.

CONTACT: Apricus Bio Investor Relations:

David Pitts

Argot Partners

212-600-1902

david@argotpartners.com


//-->