Lilly partners Kowa to sell new statin

Eli Lilly has signed a deal to co-promote Japanese drugmaker Kowa Co’s new statin Livalo in a bid to challenge the market for cardiometabolic disorders dominated by the likes of Pfizer’s Lipitor, AstraZeneca’s Crestor and the generic version of Merck & Co’s Zocor.

Under the terms of the agreement, Kowa Pharmaceuticals America will receive an undisclosed upfront payment from Lilly and the firms will co-promote Livalo (pitavastatin) in the USA and Latin America. The drug was approved by the US Food and Drug Administration in August for the treatment of primary hyperlipidaemia and mixed dyslipidaemia.

Both companies will provide sales force resources and share development and marketing costs. Kowa, will record all US sales and pay Lilly an escalating co-promotion fee based on annual sales.

Livolo is already on the market in Japan, South Korea, Thailand and China, and Kowa says it 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”, Kowa says.

Lilly chief executive John Lechleiter said that Livalo “provide patients a new option to help control their cholesterol" and the co-promotion arrangement will allow his firm to “expand our product offerings in the cardiovascular therapeutic area and more efficiently utilise our existing cardiovascular salesforce”.

The drug is certainly making an impact in Japan and sales of Livalo for fiscal year 2008 reached 34 billion yen (some $380 million), representing a market share of about 12%.