To Be Commercialized in Spain as Virirec(TM)
Additional European Launches Expected Throughout 2015
SAN DIEGO, May 6, 2015 (GLOBE NEWSWIRE) -- Apricus Biosciences, Inc. (Nasdaq:APRI), a biopharmaceutical company advancing innovative medicines in urology and rheumatology, today announced the launch of Virirec™ in Spain by Recordati. Virirec, Apricus' novel topical on-demand treatment for erectile dysfunction ("ED") is also marketed in other European countries as Vitaros® and in Belgium as Vytaros®. This is the fifth territory in the European Union (the "EU") in which the product has been launched following successful launches by Apricus' partners, Takeda in the United Kingdom (the "UK") and Sandoz in Germany, Sweden and Belgium. The product is currently approved in ten countries in Europe, including additional major ED markets such as France and Italy.
Richard Pascoe, Chief Executive Officer of Apricus, commented, "We are pleased to announce the launch of Virirec, our novel on-demand topical cream for the treatment of ED, by our partner Recordati in Spain. Spain is one of the largest ED markets in Europe with sales of approximately $85 million last year. Moreover, with Recordati's launch in Spain, coupled with expected launches in additional markets in Europe later this year by Laboratories Majorelle and Bracco, we expect that Vitaros use will continue to expand in the large and growing untreated ED patient population."
In February 2014, Apricus signed an exclusive license agreement with Recordati S.p.A. ("Recordati") (Bloomberg REC IM) to market Vitaros in Spain, Russia, Turkey, Ireland and certain other European and African countries (the "Territory") and received an upfront payment of $2.5 million.
Under the terms of the agreement and based on the OANDA exchange rate as of April 30, 2015, Apricus is eligible to receive up to approximately $38.5 million from Recordati in additional milestones, plus double-digit tiered royalties based on Recordati's net sales of the product in the Territory. In exchange, Recordati has the exclusive right to commercialize Virirec in the Territory.
Vitaros is an exciting new entrant into the ED treatment market, offering a range of benefits that make it appealing for virtually any ED patient. Vitaros is a topical ED cream that delivers rapid onset (generally 5-15 minutes), treatment duration of approximately 1 hour and a favorable safety profile. Vitaros' local delivery provides an 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 IMS Health, the global ED market in 2013 was in excess of $5.5 billion annually. Based on the OANDA exchange rate as of April 30, 2015, Vitaros has the potential to generate for Apricus over $160 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 in Asia and throughout Latin America.
About Recordati S.p.A.
Established in 1926, Recordati is an international pharmaceutical group, listed on the Italian Stock Exchange (Bloomberg REC IM), with a total staff of around 4,000, dedicated to the research, development, manufacturing and marketing of pharmaceuticals. Recordati is headquartered in Milan, Italy, with operations in the main European countries, in Russia, in other Central and Eastern European countries, in Turkey, in the United States of America and in North Africa. An efficient field force of medical representatives promotes a wide range of innovative pharmaceuticals, both proprietary and under license, in a number of therapeutic areas including a specialized business dedicated to treatments for rare diseases. Recordati is a partner of choice for new product licenses for its territories. Recordati is committed to the research and development of new drug entities within the urogenital therapeutic area and of treatments for rare diseases.
For further information, please visit the Recordati website: www.recordati.com.
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 Mylan NV, Takeda Pharmaceuticals International GmbH, Hexal AG (Sandoz), Recordati (Recordati S.p.A.), Bracco S.p.A. and Laboratoires Majorelle. Apricus' second-generation room temperature Vitaros is under development. Apricus 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 2 trial for fispemifene, a selective estrogen receptor modulator for the treatment of male secondary hypogonadism, chronic prostatitis and lower urinary tract symptoms.
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 timing of planned launches of Vitaros® in various countries by Apricus' commercial partners; the potential for the product to achieve commercial success generally or in any specific territory and for Apricus to receive future milestone and royalty revenue; Apricus' intention to expand licensing efforts in additional markets; and the size of the commercial opportunity for the product, particularly in Recordati's Territory. Actual results could differ from those projected in any forward-looking statements due to a variety of reasons that are outside of Apricus' control, including, but not limited to: Apricus' dependence on its commercial partners to carry out the commercial launch or grow sales of Vitaros in various territories, such as Recordati in the Territory, Takeda in the United Kingdom and Sandoz in Sweden, Germany and Belgium; competition in the ED market and other markets in which Apricus and its partners operate; Apricus' ability to obtain and maintain intellectual property protection for the product; Apricus' ability to raise additional funding that it may need to continue to pursue its commercial and business development plans; the fluctuation of currency exchange rates; the potential for adverse reactions to the product; our ability to negotiate and enter into acceptable terms for new licensing agreements; 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.