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Apricus Biosciences' Wholly-Owned Subsidiary NexMed (U.S.A.) And Takeda Pharmaceuticals International GmbH Sign Exclusive License Agreement To Market Vitaros(R) In The United Kingdom

Stocks in this article: APRI

SAN DIEGO and ZURICH, Switzerland, Sept. 13, 2012 (GLOBE NEWSWIRE) -- Apricus Biosciences, Inc. (Nasdaq:APRI) and Takeda Pharmaceuticals International GmbH jointly announced today that they have entered into an exclusive license agreement to market Vitaros ®, a treatment for erectile dysfunction, in the UK.

Apricus logo
Takeda Pharmaceuticals International GmbH Logo

Under the terms of the agreement, Takeda will pay NexMed (U.S.A.), a wholly owned subsidiary of Apricus Biosciences, an undisclosed upfront payment, and milestone payments of up to €35 million. According to IMS Health, the erectile dysfunction market in the United Kingdom was worth approximately €202 million in 2011.

Dr. Bassam Damaj, President and Chief Executive Officer of Apricus Bio commented, "We look forward to expanding the reach of our Vitaros ® product for erectile dysfunction in the UK, the second largest ED market in Europe. Takeda is a research-based global pharmaceutical company and a well-known and trusted name in the industry. This partnership further demonstrates our commitment to our commercialization strategy to make Vitaros ® available to patients worldwide."

"This is a great opportunity for Takeda UK," said Yasuhiro Fukutomi, Managing Director, Takeda UK. "Takeda is committed to providing novel and innovative treatments that make a real difference to patients' lives. Vitaros ® is an innovative new product that offers the potential to provide men with a new first line or alternative treatment option. Vitaros ® has been shown in clinical trials to provide rapid, on-demand efficacy together with convenient local administration that is well tolerated. 1,2 Takeda UK envisages that Vitaros ® will be a significant addition to our urology franchise."

The marketing authorization application for Vitaros ® was accepted by the European Medicines Agency for review in June 2011 and the license is anticipated in 2013. Vitaros ® has received marketing authorization in Canada and is being marketed by Abbott Laboratories Ltd. In the USA, commercial rights to Vitaros ® have been licensed to Warner Chilcott. Agreements have also been signed with Sandoz-Novartis in Germany, Bracco in Italy, Elis Pharmaceuticals in certain Middle East, and Gulf countries, and Neopharm in Israel.

Notes to Editors

About Vitaros ®

Vitaros ® is a topically delivered formulation (cream) of alprostadil (a vasodilator) supplied in a single dose dispenser (AccuDose™), for the treatment of erectile dysfunction (ED). It is delivered with Dodecyl 2-N, N-(dimethylamino)-propionate hydrochloride (DDAIP HCl), Apricus' proprietary NexACT ® delivery technology.

NexACT ® utilizes biodegradable excipients, that when incorporated into drug formulations, has demonstrated the ability to help overcome the body's natural barrier properties and thereby enable rapid penetration of higher concentrations of active drug directly through the skin and major biological membranes, resulting in more effective delivery of therapies. When absorbed through the skin alprostadil directly boosts blood flow, thereby causing an erection. 2 Clinical studies have shown that Vitaros ® works on average in approximately 15 minutes, compared to a reported onset time of 30 minutes, or longer, for oral medications. 2

Vitaros ® is applied directly to the penis and absorbed locally, instead of being administered orally. This topical application provides men who are unable to take existing oral medication with a patient-friendly alternative. Vitaros ® has been studied in over 3,300 patients 3 including difficult to treat populations (diabetes, cardiac issues, sildenafil failures, prostatectomies, patients on nitrates and alpha blockers). 1 Vitaros ® demonstrates clinical efficacy and a favorable safety profile versus currently approved oral medication. 1

About Erectile Dysfunction

Erectile dysfunction, or impotence, is the persistent or recurrent inability to attain or maintain an erection sufficient to complete sexual intercourse or another chosen sexual activity. 4

References

1.    Padma-Nathan H and Yeager JL. An integrated analysis of alprostadil topical cream for the treatment of erectile dysfunction in 1732 patients. Urology 2006: 68; 386–391.

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