Date: 2013-07-09
Type of information: Commercialisation agreement
Compound: Spedra™ (avanafil)
Company: Vivus (USA - CA) Menarini (Italy)
Therapeutic area:
Type agreement: commercialisation
promotion
Action mechanism: phosphodiesterase inhibitor. Spedra®/Stendra® belongs to a class of drugs called phosphodiesterase type 5 (PDE5) inhibitors, which are used to help increase blood flow to the penis. As with other PDE5 inhibitors, Stendra® should not be used by men who also take nitrates, commonly used to treat chest pain (angina), because the combination can cause a sudden drop in blood pressure.
Disease: erectile dysfunction
Details: * On July 9, 2013, Vivus has entered into a License and Commercialisation 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 FDA in April 2012 and by the European Commission (EC) in June 2013 for the treatment of erectile dysfunction (ED). In the EU, Menarini expects to field a sales force of 1,350 representatives to promote Spedra™.
Vivus and Menarini also entered into a supply agreement whereby Vivus will supply Menarini with commercial product.
Financial terms: 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 make payments to cover various obligations to Mitsubishi-Tanabe Pharmaceutical Company (MTPC) during the term of the agreement. Vivus is eligible to receive up to €75 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.
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