Healthcare Industry News: S.A.
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 Kingdom
SAN 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. BaS.A. 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.reS.A.ch-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.A. 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.A.cepted by the European MedicineS.A.ency for review in June 2011 and the license iS.A.ticipated 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 IS.A.l.
About Vitaros(R)
Vitaros(R) iS.A.topically delivered formulation (cream) of alproS.A.il (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.A.d 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 alproS.A.il 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.A.plied directly to the peniS.A.d 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, proS.A.ectomies, patients on nitrateS.A.d 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
References
1. Padma-Nathan H and Yeager JL. An integrated analysis of alproS.A.il topical cream for the treatment of erectile dysfunction in 1732 patients. Urology 2006: 68; 386--391.
2. Becher E. Topical alproS.A.il 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.A.d markets innovative treatments that help large patient populationS.A.ross numerous, high-demand therapeutic classes. The Company has four approved productS.A.d has developed a strong pipeline of multiple late-S.A.e product candidates. With commercial operations in both the U.S. and Europe (France), Apricus Bio generates revenueS.A.d growth from sales of its commercial productS.A.d by out-licensing, in certain territories, its pipeline productS.A.d 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 NAS.A. 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 S.A.ement Safe Harbor
S.A.ements under the Private Securities Litigation Reform Act, aS.A.ended: with the exception of the historical information contained in this release, the matters described herein contain forward-looking S.A.ements that involve riskS.A.d 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.A.ility to further develop itS.A.d their productS.A.d product candidates, to have its productS.A.d product candidateS.A.proved by relevant regulatory authorities, including Europe, to successfully commercialize such NexACT(R) productS.A. Vitaros(R) for erectile dysfunction and product candidateS.A.d to achieve its development, commercialization and financial goals with Takeda in the United Kingdom and other countries. ReaderS.A.e cautioned not to place undue reliance on these forward-looking S.A.ementS.A. actual results could differ materially from the forward-looking S.A.ements contained herein. ReaderS.A.e 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.A.e 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.reS.A.ch-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.A.ailable through its corporate website, www.takeda.com.
Takeda forward-looking S.A.ement
This press release contains forward-looking S.A.ements. Forward-looking S.A.ements include S.A.ements regarding Takeda'S.A.d Apricus Bio's plans, outlook, strategies, results for the future, and other S.A.ements that are not descriptions of historical facts. Forward-looking S.A.ements 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 S.A.ementS.A.e based on estimateS.A.d assumptions made by management that are believed to be reasonable, though they are inherently uncertain and difficult to predict. InvestorS.A.e cautioned not to unduly rely on such forward-looking S.A.ements.
Forward-looking S.A.ements involve riskS.A.d uncertainties that could cause actual results or experience to differ materially from that expressed or implied by the forward-looking S.A.ements. Some of these riskS.A.d uncertainties include, but are not limited to, (1) the economic circumS.A.ces surrounding Takeda'S.A.d Apricus Bio's business, including general economic conditions in Japan, the United S.A.eS.A.d worldwide; (2) competitive pressureS.A.d developments; (3) applicable lawS.A.d regulations; (4) the success or failure of product development programs; (5) actions of regulatory authoritieS.A.d 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 S.A.ements 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 S.A.ements to reflect new information, future events or circumS.A.ceS.A.ter the date of the forward-looking S.A.ement. If Takeda and Apricus Bio do update or correct one or more of these S.A.ements, investorS.A.d others should not conclude that Takeda will make additional updates or corrections.
Source: Apricus Biosciences
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