The USA’s CV Therapeutics has granted exclusive rights for its angina drug Ranexa in Europe and other countries to Italy’s Menarini Group.
The agreement, which includes the European Union, the Commonwealth of Independent States and select countries of Central and South America, will see Menarini make an upfront payment of $70 million. The Italian firm may also pay out up to $315 million in commercial and development milestones for certain additional indications of Ranexa (ranolazine).
CV is also entitled to receive royalties on sales of Ranexa, which Menarini expects to launch in Germany and the UK in the first quarter of 2009. The drug is approved as add-on therapy for patients with stable angina pectoris who are inadequately controlled or intolerant to first-line antianginal treatments.
Explaining the choice of Menarini as a partner, CV chief executive Louis Lange said “their proven ability to launch and promote cardiovascular products suggests they are exceptionally well positioned to launch Ranexa to both specialists and primary care physicians”. The Italian firm helps sell some of the best-selling drugs in Europe, including Pfizer’s Lipitor (atorvastatin) and AstraZeneca’s Nexium (esomeprazole). It makes the most physician calls for cardiovascular products and has the fourth largest pharmaceutical sales team in Europe.
CV notes that it is seeking changes to the labelling for Ranexa in the USA to include a first-line angina indication, “a significant reduction in cautionary language”, and the potential addition of promotable claims for the reduction of haemoglobin A1c and ventricular arrhythmias in patients with coronary artery disease.
