Dgap-news: apricus biosciences and neopharm group sign licensing agreement for vitaros(r) in israel for up to $4.35 million, plus royalties

firmenpresse.de | 14.02.2011 - 16:14 | ID: 348169 DGAP-News: Apricus Biosciences and Neopharm
Group Sign Licensing Agreement for Vitaros(R) in
Israel for up to $4.35 Million, Plus Royalties
14.02.2011 16:14--------------------------------------------------------------------------- SAN DIEGO, 2011-02-14 16:14 CET (GLOBE NEWSWIRE) --Apricus Biosciences, Inc. ('Apricus Bio')(Nasdaq:APRI), announced today thatit has entered into a licensing agreement granting Neopharm Group ('Neopharm')the exclusive rights to market and sell Vitaros(r), Apricus Bio's treatment forerectile dysfunction ('ED') and, when and if available, its formulation for thetreatment of premature ejaculation ('PE'), in Israel and the PalestinianTerritories of the Gaza Strip and the West Bank. On November 12, 2010, Apricus Bio announced that Health Canada had approvedVitaros(r) for marketing as the first topical treatment for ED in that country.
The application for approval to market Vitaros(r) for ED in Israel is scheduledto be filed in the first half of 2011 and later, in the PalestinianTerritories. Under the terms of the licensing agreement, Neopharm has been granted exclusiverights in Israel and the Palestinian Territories to commercialize and marketVitaros(r) under the Vitaros(r) trademark for ED and, when and if available,Apricus Bio's formulation for PE. In return, Apricus Bio is entitled to receiveup to a total of $4.35 million in up-front, regulatory and sales milestonepayments for the products. Further, over the life of the agreement, Apricus Biowill receive tiered, double-digit royalties based on Neopharm's sales of theproducts. Commenting on today's announcement, Dr. Bassam Damaj, President and ChiefExecutive Officer of Apricus Bio, stated, 'We are delighted to be able toannounce yet another licensing and commercialization agreement for our firstproduct, Vitaros(r), that utilizes our proprietary NexACT(r) technology. SinceDecember 22, 2010, we have closed three licensing and commercializationtransactions covering 14 countries. We also continue to talk with numerousother potential partners to increase the number of these transactions and tobroaden the potential market for Vitaros(r).' David Fuhrer, Chairman of the Neopharm Group, commented, 'I am confident that our well established expertise and heritage in partnership with innovativebiopharmaceutical companies will make Vitaros(r) a success in Israel. We seeVitaros(r) as an excellent addition to our group's strong and growing portfolioof innovative products.' According to Neopharm, the ED market in Israel and the Palestinian Territoriesis dominated by oral PDE5 treatments. However, there is still a need for new,safe and effective treatments, especially for those patients who cannot or donot respond well to oral medication. Vitaros(r) differs from oral PDE5 drugs likeViagra(r), Cialis(r) and Levitra(r) in two ways. First, it is applied directly to thepenis as a cream, instead of as a pill that is absorbed systemically. Thetopical application helps to reduce side effects and enables men who cannottake, or do not do well with the existing drugs, to have a patient-friendlyalternative. Second, Vitaros(r) operates by a different biochemical mechanism than oral EDmedications, and causes erections to occur in a more localized fashion and morequickly when compared to oral treatments. Vitaros(r) contains a previouslymarketed ED drug, known by the chemicalname of alprostadil. When absorbedthrough the skin, alprostadil, a vasodilator, directly boosts blood flow,thereby causing an erection. Clinical studies have shown that Vitaros(r) works onaverage in approximately 15 minutes, compared to a reported onset time of 30minutes or more for oral medications indicated for the treatment of ED. Theside effects reported were localized and transient. Alprostadil is currently marketed as an injectable drug. Apricus Bioincorporated alprostadil with its NexACT(r) delivery technology, resulting in arapid and efficient topical delivery of the drug into the penis. In clinicalstudies, Vitaros(r) worked in patients suffering from mild to severe ED,including men who did not respond to Viagra(r). Viagra(r) is a registered trademarkof Pfizer, Inc.; Cialis(r) is a registered trademark of Lilly, USA; Levitra(r), isa registered trademark of Bayer A.G.; Vitaros(r) is a registered trademark inIsrael held by Apricus Bio through its subsidiary NexMed International Limited,and in the U.S. held by Warner Chilcott Company. Established in 1941, Neopharm Group is one of Israel's leading providers ofinnovative integrated solutions across the pharmaceutical, medical andhealthcare markets. Neopharm has a long heritage of collaboration with leadingmultinational corporations and is positioned as the partner-of-choice andone-stop-shop for multinational corporations seeking to enter or expend theirbusiness in the Israeli healthcare market. The group has expertise andstrengths in marketing of pharmaceuticals and biological products includingniche and orphan drugs, hospital products, vaccines, medical devices,diagnostic products, medical and scientific equipment, OTC/CH products, medicalservices and home therapy - all of which enabled the group to grow and becomethe second largest provider to the Israeli healthcare market with annualrevenues exceeding $300M, and 600 employees. The Neopharm Group isheadquartered in Petach Tiqva, Israel. www.neopharmisrael.com Apricus Bio, a San Diego based revenue-generating pharmaceutical company, hasleveraged the flexibility of its clinically-validated NexACT(r) drug deliverytechnology to enable multi-route administration of new and improved compoundsacross numerous therapeutic classes. Future growth is expected to be driventhrough out-licensing of this technology for the development andcommercialization of such compounds to pharmaceutical and biotechnologycompanies, worldwide, as well as by monetizing its existing product pipeline,including its approved drug erectile dysfunction treatment, Vitaros(r), inaddition to compounds in development from pre-clinical through Phase III,currently focused on Sexual Dysfunction, Oncology, Dermatology, Autoimmune,Pain, Anti-Infectives, Diabetes and Cosmeceuticals, among others. For furtherinformation on Apricus Bio and its subsidiaries, visithttp://www.apricusbio.com Apricus Bio's Forward-Looking Statement Safe Harbor Statements under the Private Securities Litigation Reform Act, as amended: withthe exception of the historical information contained in this release, thematters described herein contain forward-looking statements that involve risksand uncertainties that may individually or mutually impact the matters hereindescribed for a variety of reasons that are outside the control of the Company,including, but not limited to, timing for seeking foreign approvals forVitaros(r) for erectile dysfunction and for a chemical formulation similar toVitaros(r) for premature ejaculation, timing and success of the commercial launchof Vitaros(r) in Italy, The Gulf Countries and part of the Middle East and inIsrael and the Palestinian Territories, the potential size of the market, theability to develop and commercialize the Company's products on its own and withpartners and the ability to meet its milestones. Readers are cautioned not toplace undue reliance on these forward-looking statements as actual resultscould differ materially from the forward-looking statements contained herein.
Readers are urged to read the risk factors set forth in the Company's mostrecent annual report on Form 10-K, subsequent quarterly reports filed on Form10-Q and other filings made with the SEC. Copies of these reports are availablefrom the SEC's website or without charge from the Company. CONTACT: Apricus Biosciences, Inc.
Edward Cox, V.P.
Investor Relations&Corporate Development, Apricus Bio, Inc.
(858) 848-4249ecox@apricusbio.com Apricus Bio Investor RelationsPaula SchwartzRx Communications Group, LLC(917) 322-2216pschwartz@rxir.com Neopharm Group, Israelbd@neopharmisrael.com+972 3 9373783 Uri Goren,Spokesman and PR Manageruri.g@neopharmgroup.com+972-52-7444680News Source: NASDAQ OMX 14.02.2011 Dissemination of a Corporate News, transmitted by DGAP - a company of EquityStory AG.
The issuer is solely responsible for the content of this announcement.
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