Recordati has signed a license agreement with Esteve for the marketing and sales in Spain of its new cholesterol drug pitavastatin.

The Italian drugmaker got hold of European rights for pitavastatin, a novel statin for the treatment of hypercholesterolemia, when it signed a marketing deal with Japan’s Kowa Co in October 2008. It will co-market the product with Esteve and the firms noted that the drug is currently being evaluated by the UK Medicines and Healthcare products Regulatory Agency and is expected to be launched in Europe in the second half of 2010.

Pitavastatin is already on the market in Japan, South Korea, Thailand and China and was approved by the US Food and Drug Administration in August. The drug will be co-promoted in the USA and Latin America by drug major Eli Lilly as Livalo.

The statins market is a crowded one, dominated by the likes of Pfizer’s Lipitor (atorvastatin), AstraZeneca’s Crestor (rosuvastatin) and the generic version of Merck & Co’s Zocor (simvastatin). However Recordati says the drug differs from other statins as pitavastatin is only minimally metabolised by the liver through the cytochrome P450 pathway. This suggests that the potential for clinically significant drug interactions between Livalo and drugs that inhibit or that are metabolised by CYP450 enzymes, including warfarin, would be reduced.