SAN DIEGO, Aug. 29, 2013 (GLOBE NEWSWIRE) -- Apricus Biosciences, Inc. ("Apricus Bio" or the "Company") (Nasdaq:APRI) (www.apricusbio.com), today announced that Swissmedic, the Agency for Therapeutic Products in Switzerland, has recommended against approval of marketing authorization for Vitaros® for the treatment of erectile dysfunction ("ED") based on certain quality related issues. Vitaros® is currently approved in Europe through the European Decentralized Procedure ("DCP") and in Canada as a first line treatment for ED.
In rendering their decision, Swissmedic informed Apricus Bio that the previously submitted pre-clinical and clinical data were satisfactory and would likely support an approval. However, the Agency also noted that the data provided by the Company pertaining to the targeted shelf life of the product's cold chain formulation was insufficient to support the approvability of Vitaros® at this time. The Company intends to submit an appeal regarding this decision within thirty days.
"While we remain pleased that the safety and efficacy assessment of our pre-clinical and clinical data package supports the approval of Vitaros®, we believe that we have sufficient grounds for an appeal, which we intend to pursue," said Richard Pascoe, Chief Executive Officer of Apricus Bio. "Moreover, we will continue to concentrate our efforts on obtaining additional DCP national phase approvals for Vitaros®, supporting the product's launch in the major European markets, and securing additional partnerships in available territories. We look forward to working closely with Swissmedic toward the goal of making Vitaros® available to ED patients across all of Europe."
The Company recently announced that, subsequent to DCP approval, Vitaros® has now received national phase approvals in Ireland, the Netherlands, Sweden and the United Kingdom. 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, Germany, 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.
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 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 interest and 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 erectile dysfunction, 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, Switzerland 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.
Source:Apricus Biosciences, Inc.