First Topical, Fast-Acting, On-Demand Treatment for Erectile Dysfunction Approved in One of Europe's Largest Markets
Apricus Remains On-Track to Announce Additional Vitaros® Partnering Transactions in Q4 2013
SAN DIEGO, Oct. 7, 2013 (GLOBE NEWSWIRE) -- Apricus Biosciences, Inc. ("Apricus Bio" or the "Company") (Nasdaq:APRI) (www.apricusbio.com), today announced that Germany's Federal Institute for Drugs and Medical Devices (BfArM) 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 five national phase approvals for Vitaros®, including Germany, Ireland, the Netherlands, Sweden and the United Kingdom ("UK").
"National phase approval of Vitaros® in Germany, one of the largest ED markets in Europe, is another important milestone for the Company," said Richard Pascoe, Chief Executive Officer of Apricus Bio. "We look forward to working with Sandoz, our commercialization partner in Germany, to move Vitaros® toward a successful launch in this key territory. Our regulatory efforts, along with actions taken by our existing European partners, continue to be on track to obtain the remaining five of ten European approvals from the fourth quarter of 2013 through the first quarter of 2014."
In June 2013, Apricus Bio announced that its marketing application for Vitaros® was approved through the European Decentralized Procedure ("DCP"). 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 Company continues to work independently, as well as with its commercialization partners, to obtain country-by-country national phase approvals in the remaining CMS territories including France, Italy, 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 Bio's 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 systematic effects of PDE5 inhibitors, it is well-positioned for commercial success. In Europe alone, the existing ED products generated over $1 billion in sales in 2012. Apricus Bio 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 UK, Sandoz in Germany, Bracco in Italy and Abbott in Canada. Apricus Bio has launched a comprehensive partnering process with the goal of licensing Vitaros® in the remaining un-partnered territories in Europe, Latin America and North Africa. Apricus Bio has received and reviewed multiple bids for the available territories and has narrowed the number of potential partners to a select group with which it will negotiate terms. Moreover, the Company remains on track to complete this process in the fourth quarter of this year.
About Vitaros®
Vitaros® has been approved for the treatment of Erectile Dysfunction ("ED") by the 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 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 nearly 150 million men worldwide who suffer from erectile dysfunction and an ED market size of approximately $1 billion in revenue in Europe alone, Vitaros® represents a major market opportunity for Apricus Bio 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 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 Laboratories Limited, Takeda Pharmaceuticals International GmbH, Hexal AG (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 proof-of-concept study.
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 ED, and product candidate Femprox® for Female Sexual Interest and 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; 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. 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.