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Menarini to Launch and Market SPEDRA in 40 Countries in Europe and Abroad
VIVUS to Receive Upfront Payment Plus Milestones and Royalties Over the Term of the Agreement
MOUNTAIN VIEW, Calif., July 9, 2013 (GLOBE NEWSWIRE) -- VIVUS, Inc. (Nasdaq:VVUS) today announced that it has entered into a License and Commercialization Agreement and a Supply Agreement with Menarini and its wholly-owned subsidiary BERLIN-CHEMIE AG/MENARINI, to commercialize and promote SPEDRA™ (avanafil) in over 40 European countries plus Australia and New Zealand. SPEDRA is a new phosphodiesterase-5 inhibitor (PDE5-i) approved under the trade name STENDRA™ by the U.S. FDA in April 2012 and by the European Commission (EC) in June 2013 for the treatment of erectile dysfunction (ED).
The Menarini Group is the leading Italian pharmaceutical company in the world with over 125 years of history. Menarini, a private company headquartered in Florence, Italy, has a 2012 turnover of more than €3.2 billion ($4.2 billion) and has over 16,000 employees worldwide. In the EU, Menarini expects to field a sales force of 1,350 representatives to promote SPEDRA.
"Menarini will be an excellent partner for SPEDRA," stated Timothy E. Morris, senior vice president, global corporate development and finance and CFO of VIVUS, Inc. "Menarini has tremendous know how and marketing capabilities throughout Europe and has already established a presence in men's health with the acquisition last year of Priligy
® (Dapoxetine) for treatment of premature ejaculation (PE). The licensing process was competitive and Menarini was chosen for their extensive presence in their territories and their history of successful drug launches across Europe. We look forward to a long and productive collaboration with Menarini."
VIVUS will receive an upfront payment and various approval and sales milestones plus royalties on SPEDRA sales. Within the first year, VIVUS is expected to receive approximately €39 million (or approximately $51 million at current exchange rates) including upfront payments totaling €16 million (or approximately $21 million at current exchange rates). Menarini will also reimburse VIVUS for payment made to cover various obligations to Mitsubishi-Tanabe Pharma Company (MTPC) during the term of the agreement. VIVUS is eligible to receive up to €79 million (or approximately $102 million at current exchange rates) in milestones and other payments over the life of the agreement in addition to royalties. The agreement will continue on a country-by-country basis in the Menarini Territory, until the latest of: expiration of the last-to-expire valid VIVUS patent covering SPEDRA; data protection covering SPEDRA; or ten (10) years after the SPEDRA product launch. VIVUS and Menarini also entered into a supply agreement whereby VIVUS will supply Menarini with commercial product.