Menarini will pay $70 million upfront to CV Therapeutics for the exclusive rights to Ranexa®, approved for chronic angina. Menarini could make additional payments and investments totaling $315 million in milestones and commitments.
Under the agreement terms, Menarini gains rights in 68 countries including the 27 EU nations, the Commonwealth of Independent States, and select countries of Central and South America. Menarini is expected to launch Ranexa in Germany and the U.K in the first quarter of 2009. CV Therapeutics will receive royalties on sales in all these regions.
Success-based fees are linked to approval of Ranexa in Europe for certain additional indications that are jointly developed and are also dependant on sales levels.
Menarini will be responsible for commercial activities and pursuing regulatory and pricing approvals. CV Therapeutics is also entitled to receive royalties on sales of Ranexa.
Ranexa is approved for use in Europe as add-on therapy for the symptomatic treatment of patients with stable angina pectoris who are inadequately controlled or intolerant to first-line antianginal therapies. In the U.S., Ranexa is indicated for the treatment of chronic angina in patients who have not achieved an adequate response with other antianginal drugs.