In total, the agreement grants rights to Menarini for Ranexa in 68 countries, including the 27 countries of the EU, the Commonwealth of Independent States, and select countries of central and South America.
In the agreement, Menarini has committed to make an upfront payment of $70 million in consideration of the rights granted and in recognition of the R&D investments made by CV Therapeutics. In addition, Menarini will potentially make additional payments and investments totaling up to $315 million (based on the current currency exchange rate) for commercial and development milestones and promotional and detailing commitments.
The commercial milestones are primarily linked to sales levels and the development milestones are linked to approval of Ranexa in Europe for certain additional indications that are jointly developed. The agreement provides mechanisms for the parties to collaborate and share the costs of joint development of Ranexa.
Menarini will be responsible for commercial activities and pursuing regulatory and pricing approvals. As part of the agreement, Menarini has committed to provide minimum levels of physician details and promotional spending for Ranexa for a specified period of time.
In addition to upfront and milestone payments and potential development expense reimbursement, CV Therapeutics is entitled to receive royalties on sales of Ranexa in the territories covered by the agreement. Under the terms of the agreement, Menarini is expected to launch Ranexa in Germany and the UK in the first quarter of 2009 with commercial launch in the other licensed territories expected following formal pricing and reimbursement authorizations in those countries.
Ranexa (ranolazine prolonged release tablets) 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. Ranexa is approved for use in 375mg, 500mg and 750mg doses, administered twice daily.