Apricus Expands Exclusive License Agreement to Market Vitaros
Apricus Expands Exclusive License Agreement With Its Partner in Germany to Market Vitaros(R) in Additional European Countries
Apricus Eligible to Receive Up to $63 Million in Combined
Upfront, Regulatory, Launch and Sales Milestone Payments,
Plus Double-Digit Tiered Royalties
SAN DIEGO, Dec. 16, 2013 (GLOBE NEWSWIRE) -- Apricus Biosciences, Inc. ("Apricus" or the "Company") (Nasdaq:APRI) (www.apricusbio.com), announced today that it has 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(R), indicated for the treatment of patients with erectile dysfunction ("ED"). In addition to the in-place collaboration in Germany, this expanded agreement now includes Austria, Belgium, Denmark, Finland, Iceland, Luxemburg, the Netherlands, Norway, Sweden and Switzerland (the "Expanded Territory").
In combination with the previously signed license agreement for Germany, Apricus is now eligible to receive up to approximately $63 million from Sandoz in upfront, regulatory, launch and sales milestone payments for Vitaros(R) in Germany and the Expanded Territory, which includes up to $4.5 million in new upfront and launch milestone compensation for the Expanded Territory.
"This expanded commercialization agreement with Sandoz accomplishes one of our key corporate objectives -- the expansion of an existing
Vitaros(R) partnership in Europe," said Richard Pascoe, Chief Executive Officer of Apricus. "We are pleased with the strong working relationship we have with Sandoz and we look forward to supporting their team as they bring this novel, topical, on-demand ED treatment option to physicians and patients throughout Northern Europe."
Vitaros(R) was approved in Europe under the Decentralized Procedure
("DCP") in June 2013. Since then, the product has received six national phase approvals in Europe, including Germany, Ireland, Italy, the Netherlands, Sweden and the United Kingdom. Apricus continues to work independently, as well as with its license partners, to obtain country-by-country national phase approvals in the remaining CMS territories, including France, Spain, Belgium and Luxembourg. The Company's regulatory efforts, along with actions taken by its existing European license partners, are on track to obtain the remaining four European approvals during the fourth quarter of 2013 and the first quarter of 2014.
Vitaros(R) is currently licensed to Takeda in the United Kingdom, Sandoz in Germany, Austria, Benelux and the Nordics, Bracco in Italy, Laboratoires Majorelle in France, Monaco and certain Africa countries, and Abbott in Canada.
Vitaros(R) has been approved for the treatment of ED by the European Health Authorities and by Health Canada. Vitaros(R) 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(R), 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 ED and an ED market size of approximately $1 billion in revenue in Europe alone, Vitaros(R) 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(R), 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, Sandoz International GmbH, Bracco SpA and Laboratoires Majorelle. Femprox(R), 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' 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(R) for ED, such as the room temperature version of Vitaros(R), and product candidate Femprox(R) 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(R) in the remaining CMS territories and guidance on approval of Femprox(R); to successfully commercialize such product and product candidates and other NexACT(R) product candidates and drug delivery technology; and to achieve its other development, commercialization and financial goals, such as successfully manufacturing and launching Vitaros(R) in partnered territories, including Austria, Benelux and the Nordics. 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.
CONTACT: Apricus Investor Relations:
Posted: December 2013