Vitaros® on Track for European Launch in 2014
Additional Vitaros® Partnerships Expected in 4Q 2013
SAN DIEGO, Nov. 25, 2013 (GLOBE NEWSWIRE) -- Apricus Biosciences, Inc. ("Apricus" or the "Company") (Nasdaq:APRI) (www.apricusbio.com), today announced that the Italian Medicines Agency (AIFA) has granted national phase approval to Vitaros®, indicated for the treatment of patients with erectile dysfunction ("ED"). The Company has now received a total of six national phase approvals for Vitaros®, including Germany, Ireland, Italy, the Netherlands, Sweden and the United Kingdom ("UK") following its broad approval by European health authorities in June 2013.
"We look forward to working with Bracco, our commercialization partner in Italy, as they prepare for a successful launch of the first topical, on-demand treatment for erectile dysfunction in this key European market," said Richard Pascoe, Chief Executive Officer of Apricus. "Our regulatory efforts remain on track to obtain the remaining four European national phase approvals during the fourth quarter of 2013 and first quarter of 2014. Looking forward, our top priorities are to secure additional Vitaros® partnerships and support our commercialization partners' launch preparations in Europe. We expect to announce one or more additional Vitaros® partnerships this quarter and anticipate the rollout of multiple Vitaros® launches across Europe in 2014."
In June 2013, Apricus announced that its marketing application for Vitaros® was approved through the European Decentralized Procedure ("DCP"). Under the DCP, Apricus filed its application for marketing approval designating the Netherlands as the Reference Member State ("RMS") on behalf of nine other European Concerned Member States ("CMS") participating in the procedure. The Company continues to work toward obtaining country-by-country national phase approvals in the remaining CMS territories including France, Spain, Belgium and Luxembourg. Once the national phase approvals are secured on a country-by-country basis, marketing of Vitaros® can then be initiated in each country by Apricus' commercialization partners.
Once launched, Vitaros® will become the first new and novel ED product in nearly a decade, and with its unique product profile that addresses a large number of patients who cannot or do not respond well to the existing therapies, or who are intolerant to the systemic effects of PDE-5 inhibitors, it is well-positioned for commercial success. In Europe alone, the existing ED products generated over $1 billion in sales in 2012. Apricus believes that a significant portion of the market remains untreated or under-treated, which represents a substantial commercial opportunity for Vitaros®.
Vitaros® is currently partnered in key markets, including with Takeda in the United Kingdom, Sandoz in Germany, Bracco in Italy, Majorelle in France, Monaco and certain African countries, and Abbott in Canada. The Company's existing commercialization partners are preparing for Vitaros® product launches in their respective territories.
Apricus has received and reviewed multiple bids for commercialization rights for Vitaros® in the remaining un-partnered territories in Europe and it expects to announce additional licensing transactions by year-end 2013.
About Vitaros®
Vitaros® has been approved for the treatment of ED by European health authorities and by Health Canada. 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 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 ED and an ED market size of approximately $1 billion in revenue in Europe alone, Vitaros® represents a major market opportunity for Apricus 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 and markets through its licensing partners, innovative treatments that have the potential to 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' marketing partners, which include Abbott Laboratories Limited, Takeda Pharmaceuticals International GmbH, Hexal AG (Sandoz), Bracco SpA and Laboratoires Majorelle. Femprox®, the Company's product candidate for the treatment of female sexual interest/arousal disorder, has successfully completed a nearly 400-subject proof-of-concept study.
For further information on Apricus, visit http://www.apricusbio.com.
Apricus Biosciences' 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 ED, such as the room temperature version of Vitaros®, and product candidate Femprox® for female sexual interest/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 and in other countries, such as additional national phase approvals for Vitaros® in the remaining CMS territories and guidance on approval of Femprox®; to successfully commercialize such product and product candidates and other NexACT® product candidates and drug delivery technology; and to achieve its other development, commercialization and financial goals, such as successfully manufacturing and launching Vitaros® in partnered territories. 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, as amended, subsequent quarterly reports filed on Form 10-Q, as amended, and other filings made with the SEC. Copies of these reports are available from the SEC's website or without charge from the Company.