Healthcare Industry News: Takeda Pharmaceutical
News Release - November 13, 2013
Apricus and Laboratoires Majorelle Sign Exclusive License Agreement to Market Topical Erectile Dysfunction Cream Vitaros(R) in France, Monaco and Certain African CountriesApricus Eligible to Receive Up to $25 Million in Upfront, Regulatory and Sales Milestone Payments and Double-Digit Tiered Royalties
SAN DIEGO, Nov. 13, 2013 -- (Healthcare Sales & Marketing Network) -- Apricus Biosciences, Inc. ("Apricus" or the "Company") (APRI) (www.apricusbio.com), announced today that Apricus signed an exclusive license agreement with Laboratoires Majorelle ("Majorelle") to market Vitaros(R), its topical on-demand product for the treatment of erectile dysfunction ("ED"), in France, Monaco and certain African countries (the "Territory").
Under the terms of the agreement, Apricus is eligible to receive up to $4 million from Majorelle in upfront and regulatory milestone payments. Apricus is also eligible to receive up to approximately $21 million in milestone payments on future sales, plus double-digit tiered royalties based on Majorelle's net sales of the product in the Territory. In exchange, Majorelle will have the exclusive right to commercialize Vitaros(R) in the Territory. In addition, Majorelle has agreed to minimum marketing commitments for Vitaros(R), including the expansion of its existing sales force in France.
"Given their extensive depth and experience in the urology market, Majorelle is well equipped to bring the unique benefits of Vitaros(R) to patients and health care providers in these important territories," said Richard Pascoe, Chief Executive Officer of Apricus. "With their strong and growing commercial organization, led by a highly experienced management team, and their impressive financial commitment to marketing Vitaros(R), we look forward to Majorelle's successful launch of the only topical on-demand ED treatment in France and other French speaking countries."
"We're very excited to have an opportunity to work with Apricus and market Vitaros(R) in France, Monaco and Africa," said Majorelle's Chairman, Mehdi El Glaoui. "We have a strong urology presence in France, one of the largest ED markets in Europe, and we are committed to a robust launch of Vitaros(R) with an experienced team capable of driving sales and expanding the market. With national phase approval on the horizon, we are well positioned to bring this best in class ED treatment to patients."
Vitaros(R) 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. Apricus has received and reviewed multiple bids for commercialization rights for Vitaros(R) in the remaining un-partnered territories in Europe and it expects to announce additional licensing transactions by year-end 2013.
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, Hexal AG (Sandoz), 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.
About Laboratoires Majorelle
Laboratoires Majorelle was founded in 2001 and is headquartered in Paris, France. Majorelle has a strong, well-experienced commercialization team dedicated to urology and reproductive products for both males and females.
For further information on Majorelle, visit http://www.laboratoires-majorelle.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 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; 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 in France. 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.
Source: Apricus Biosciences
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