VIVUS, Inc. Strikes $121-Million Drug Deal

VIVUS, Inc. recently announced 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 US 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 $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,” said 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 $51 million, including upfront payments totaling approximately $21 million. 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 approximately $102 million 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.

“SPEDRA is an important addition into our commercial portfolio. The rapid onset of action and unique profile make SPEDRA an important treatment option for men with ED,” added Alberto Giovanni Aleotti, Vice Chairman of Menarini Group. “We are eagerly preparing for the launch of SPEDRA, which we expect to occur in the major EU countries early next year.”

VIVUS is currently in discussions with potential partners to commercialize STENDRA in the US and other territories throughout the world.

VIVUS is a biopharmaceutical company commercializing and developing innovative, next-generation therapies to address unmet needs in obesity, sleep apnea, diabetes and sexual health. For more information about the company, visit www.vivus.com.

Menarini is an international pharmaceutical company with over 16,000 employees worldwide and a presence in more than 100 countries in Europe, Asia, Latin America, Africa, and the Middle East, and has a 2012 turnover of more than $4.2 billion.