SAN DIEGO, Feb. 3, 2015 (GLOBE NEWSWIRE) -- Apricus Biosciences, Inc. (Nasdaq:APRI), a biopharmaceutical company advancing innovative medicines in urology and rheumatology, today announced that it has further 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®, Apricus’ novel topical on-demand treatment for erectile dysfunction (“ED”). This amendment is in addition to the in-place collaboration established with Hexal AG in Germany in 2012, and the expansion of the cooperation in 2013 to include Austria, Belgium, Denmark, Finland, Iceland, Luxembourg, the Netherlands, Norway, Sweden and Switzerland. This expanded agreement includes Malaysia, Indonesia, the Philippines, Thailand, Taiwan, Vietnam, Hong Kong and Singapore (the “New Territory”).
In combination with the terms of the previously signed license agreements with Sandoz, Apricus is eligible to receive up to approximately $63.5 million in combined upfront, regulatory and sales milestone payments, which includes up to a total of $6.4 million in upfront and pre-commercialization payments, and a double-digit royalty rate for Vitaros.
“Leveraging our strong working relationships and expanding our existing Vitaros agreements with our collaboration partners is an on-going key initiative within Apricus,” said Richard Pascoe, Chief Executive Officer of Apricus. “Having recently introduced Vitaros in Germany, Belgium and Sweden, Sandoz has set an impressive pace with their launch performance to date, and as such, we are very pleased that they have elected to increase their commitment to Vitaros in these important markets outside of Europe.” Mr. Pascoe continued, “Moreover, we will continue to seek value creating partnerships in other available territories in an effort to bring this novel ED treatment to physicians and patients throughout the world.”
Vitaros is an exciting new entrant into the ED treatment market, offering a range of clear benefits that make it ideal for virtually any ED patient. Vitaros is a topical cream ED medication that delivers rapid onset (generally 5-15 minutes), a treatment duration of approximately 1 hour and an excellent safety profile. Vitaros’ local delivery provides a very attractive alternative for all patients, but particularly those with complications that preclude them from using the orally delivered systemic treatments or who prefer to not use the injectable forms of alprostadil.
According to the most recent estimates, the global ED market in 2013 was in excess of $5.5 billion annually. Vitaros has the potential to generate for Apricus over $215 million in future milestone payments, as well as additional potential royalty revenue on net product sales based upon double-digit royalty rates through its existing commercial partnerships. In addition, Apricus intends to leverage Vitaros through additional licensing efforts in key markets such a Japan and China in Asia and throughout Latin America.
About Apricus Biosciences, Inc .
Apricus Biosciences, Inc. (APRI) is a biopharmaceutical company advancing innovative medicines in urology and rheumatology. Apricus’ lead product, Vitaros®, for the treatment of erectile dysfunction, is approved in Europe and Canada and is being commercialized in several countries in Europe. Apricus’ marketing partners for Vitaros include Abbott Laboratories Limited, Takeda Pharmaceuticals International GmbH, Hexal AG (Sandoz), Recordati Ireland Ltd. (Recordati S.p.A.), Bracco S.p.A. and Laboratoires Majorelle. Apricus’ second-generation Vitaros Room Temperature Device is under development and is expected to enhance the product’s commercial value. The Vitaros trademark is registered or has pending applications for registration in certain countries and jurisdictions around the world. The mark is not registered in all of the countries mentioned above. Apricus recently commenced a Phase 2a trial for RayVa™, its product candidate for the treatment of the circulatory disorder Raynaud’s phenomenon. Additionally, Apricus plans to initiate a Phase 2b trial for fispemifene, a selective estrogen receptor modulator for the treatment of male secondary hypogonadism, chronic prostatitis and lower urinary tract symptoms. Apricus is currently seeking a strategic partner to fund development of Femprox®, a product candidate for the treatment of female sexual interest/arousal disorder that completed an approximately 400-subject proof-of-concept study.
For further information on Apricus, visit http://www.apricusbio.com.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act, as amended. Statements in this press release that are not purely historical are forward-looking statements. Such forward-looking statements include, among other things: references to the planned launches of Vitaros® in various countries by Sandoz; the potential for the product to achieve commercial success generally or in any specific territory; the size of the commercial opportunity for the product; and the timing of Phase 2 clinical trials for fispemifene. Actual results could differ from those projected in any forward-looking statements due to a variety of reasons that are outside the control of Apricus, including, but not limited to: its ability to further develop its product Vitaros for the treatment of erectile dysfunction, such as the room temperature version of Vitaros, and its product candidates RayVa for the treatment of Raynaud’s phenomenon and fispemifene for the treatment of secondary hypogonadism, chronic prostatitis and lower urinary tract symptoms in men, as well as the timing of such events; Apricus’ ability to carry out clinical studies for RayVa and fispemifene, as well as the timing and success of the results of such studies; potential adverse side effects or other safety risks associated with fispemifene and RayVa that could delay or preclude approval; Apricus’ dependence on its commercial partners to increase sales of Vitaros in various territories, and the potential for delays in the timing of commercial launches in additional countries; competition in the erectile dysfunction market and other markets in which Apricus and its partners operate; Apricus’ ability to obtain license partners for Vitaros; Apricus’ ability to obtain and maintain intellectual property protection for Vitaros, RayVa, fispemifene or any other product candidates; Apricus’ ability to raise additional funding that it may need to continue to pursue its commercial and business development plans; Apricus’ ability to obtain the requisite governmental approval for Vitaros in the New Territory; and market conditions. These forward-looking statements are made as of the date of this press release, and Apricus assumes no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those projected in the forward-looking statements. Readers are urged to read the risk factors set forth in Apricus’ 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 at www.sec.gov or without charge from Apricus.
CONTACT: Institutional Investors: Angeli Kolhatkar angeli@areciaadvisors.com Arecia Advisors (917) 387-44770 Retail Investors: Chris Eddy, David Collins apri@catalyst-ir.com Catalyst Global (212) 924-9800
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