Healthcare Industry News: Vitaros
News Release - September 13, 2012
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 KingdomSAN DIEGO and ZURICH, Switzerland, Sept. 13, 2012 -- (Healthcare Sales & Marketing Network) -- Apricus Biosciences, Inc. (APRI) and Takeda Pharmaceuticals International GmbH jointly announced today that they have entered into an exclusive license agreement to market Vitaros(R), a treatment for erectile dysfunction, in the UK.
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 EURO35 million. According to IMS Health, the erectile dysfunction market in the United Kingdom was worth approximately EURO202 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(R) 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(R) 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(R) is an innovative new product that offers the potential to provide men with a new first line or alternative treatment option. Vitaros(R) 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(R) will be a significant addition to our urology franchise."
The marketing authorization application for Vitaros(R) was accepted by the European Medicines Agency for review in June 2011 and the license is anticipated in 2013. Vitaros(R) has received marketing authorization in Canada and is being marketed by Abbott Laboratories Ltd. In the USA, commercial rights to Vitaros(R) 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.
Vitaros(R) is a topically delivered formulation (cream) of alprostadil (a vasodilator) supplied in a single dose dispenser (AccuDose(TM)), for the treatment of erectile dysfunction (ED). It is delivered with Dodecyl 2-N, N-(dimethylamino)-propionate hydrochloride (DDAIP HCl), Apricus' proprietary NexACT(R) delivery technology.
NexACT(R) 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(R) works on average in approximately 15 minutes, compared to a reported onset time of 30 minutes, or longer, for oral medications.2
Vitaros(R) 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(R) has been studied in over 3,300 patients3 including difficult to treat populations (diabetes, cardiac issues, sildenafil failures, prostatectomies, patients on nitrates and alpha blockers).1 Vitaros(R) 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
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.
2. Becher E. Topical alprostadil cream for the treatment of erectile dysfunction. Expert Opin. Pharmacother 2004; 5(3): 623-632.
3. NexMed (USA) Inc. IND: 53,953. Investigator's Brochure. 2007.
4. Sexual Advice Association. Factsheets. For men. 8. Impotence and Erectile dysfunction? Available at: www.sexualadviceassociation.co.uk/ed (Last accessed: 18.07.2012.)
About Apricus Biosciences, Inc.
Apricus Bio (APRI) is a pharmaceutical company that develops and markets innovative treatments that help large patient populations across numerous, high-demand therapeutic classes. The Company has four approved products and has developed a strong pipeline of multiple late-stage product candidates. With commercial operations in both the U.S. and Europe (France), Apricus Bio generates revenues and growth from sales of its commercial products and by out-licensing, in certain territories, its pipeline products and NexACT(R) technology.
Apricus Bio's growth strategy is to acquire, develop, and commercialize new products through strategic partnerships. The Company currently has commercial partnerships with multiple large pharmaceutical companies including Novartis, Abbott Laboratories, Sandoz, Warner Chilcott and Bracco, and co-promotes multiple products in France.
Apricus Bio is headquartered in San Diego, CA and is publicly traded on the NASDAQ Capital Market under the ticker symbol APRI.
For further information on Apricus Bio, visit http://www.apricusbio.com. You can also receive information at http://twitter.com/apricusbio.
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 and their products and product candidates, to have its products and product candidates approved by relevant regulatory authorities, including Europe, to successfully commercialize such NexACT(R) products as Vitaros(R) for erectile dysfunction and product candidates and to achieve its development, commercialization and financial goals with Takeda in the United Kingdom and other countries. 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.
About Takeda Pharmaceuticals International GmbH
Takeda Pharmaceuticals International GmbH headquartered in Zurich, is a wholly owned subsidiary of Takeda Pharmaceutical Company Limited located in Osaka, Japan. Takeda is a research-based global company with its main focus on pharmaceuticals. As the largest pharmaceutical company in Japan and one of the global leaders of the industry, Takeda is committed to strive towards better health for patients worldwide through leading innovation in medicine.
Additional information about Takeda is available through its corporate website, www.takeda.com.
Takeda forward-looking statement
This press release contains forward-looking statements. Forward-looking statements include statements regarding Takeda's and Apricus Bio's plans, outlook, strategies, results for the future, and other statements that are not descriptions of historical facts. Forward-looking statements may be identified by the use of forward-looking words such as "may," "believe," "will," "expect," "project," "estimate," "should," "anticipate," "plan," "assume," "continue," "seek," "pro forma," "potential," "target," "forecast," "guidance," "outlook" or "intend" or other similar words or expressions of the negative thereof. Forward-looking statements are based on estimates and assumptions made by management that are believed to be reasonable, though they are inherently uncertain and difficult to predict. Investors are cautioned not to unduly rely on such forward-looking statements.
Forward-looking statements involve risks and uncertainties that could cause actual results or experience to differ materially from that expressed or implied by the forward-looking statements. Some of these risks and uncertainties include, but are not limited to, (1) the economic circumstances surrounding Takeda's and Apricus Bio's business, including general economic conditions in Japan, the United States and worldwide; (2) competitive pressures and developments; (3) applicable laws and regulations; (4) the success or failure of product development programs; (5) actions of regulatory authorities and the timing thereof; (6) changes in exchange rates; (7) claims or concerns regarding the safety or efficacy of marketed products or product candidates in development; and (8) integration activities with acquired companies.
The forward-looking statements contained in this press release speak only as of the date of this press release, and Takeda and Apricus Bio undertake no obligation to revise or update any forward-looking statements to reflect new information, future events or circumstances after the date of the forward-looking statement. If Takeda and Apricus Bio do update or correct one or more of these statements, investors and others should not conclude that Takeda will make additional updates or corrections.
Source: Apricus Biosciences
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