Recordati has signed an agreement with Japan's Kowa Co giving the Italian drugmaker marketing rights to the cholesterol drug pitavastatin.

The deal covers France, Spain, Portugal, Greece, Ireland, Cyprus, Turkey, Russia and the Commonwealth of Independent States, as well as Italy. Pitavastatin was submitted by Kowa at the end of August in the seven European Union countries covered by the agreement and Recordati will seek approval in the remaining countries.

The Milan-headquartered firm said that in clinical trials involving more than 1,600 patients, it has been shown that pitavastatin is more effective than other statins, “since its affinity for the HMG-CoA enzyme is stronger”. It added that the high bioavailability and long half-life of the drug “ensure the prolonged effect of the statin and support the rationale for a once-daily dosing”.

Pitavastatin is already available in Japan and Korea, and has already reached a 10% market share. Launches in the territories covered by the agreement is expected to take place from the second half of 2010.

Chief executive Giovanni Recordati said the agreement with Kowa represents an important opportunity to extend the company’s presence in the cardiovascular area, “and in particular to be present in a significant way in the market for anti-cholesterol treatments, the most important therapeutic class in the global pharmaceutical market”. He noted that the statins sector in the eight largest of the 21 countries covered by the agreement was worth 2.8 billion euros in 2007.

This is expected to grow further in the future, he added, particularly in emerging markets such as Turkey, Russia and the CIS countries. “Pitavastatin is an innovative drug with an improved clinical profile over the statins currently in use which will allow us to reach interesting market shares in a very competitive drug class”, Mr Recordati concluded.