Lilly and Kowa Pharmaceuticals America, a subsidiary of Kowa Co., Ltd., have entered into a co-promotion agreement to commercialize Livalo (pitavastatin) in the U.S. and entered into a licensing agreement in Latin America. Livalo is a statin approved by the FDA in August 2009 for the treatment of primary hyperlipidemia and mixed dyslipidemia.

Under the terms of the agreements, Kowa Pharmaceuticals America will receive an undisclosed upfront payment. Lilly and Kowa Pharmaceuticals America will co-promote the drug in the U.S., with both companies providing sales resources and sharing development and marketing costs. Kowa Pharmaceuticals America will record all U.S. sales and will pay Lilly an escalating co-promotion fee based on annual sales. Additionally, Lilly has acquired an exclusive license from Kowa to commercialize Livalo in Latin American markets, including Mexico, Central America and South America. Additional terms were not disclosed.

“We are pleased to partner with Kowa to help bring this new statin to market and provide patients a new option to help control their cholesterol,” said John Lechleiter, Ph.D., Lilly chairman and chief executive officer. “Our co-promotion arrangement in the U.S. and licensing arrangement in Latin America will allow Lilly to expand our product offerings in the cardiovascular therapeutic area and more efficiently utilize our existing cardiovascular sales force.”

“It is with great pleasure that we partner with an internationally-renowned company like Lilly,” said Yoshihiro Miwa, Kowa president and chief executive officer. “With a joint effort by Lilly, Kowa and Kowa Pharmaceuticals America, we hope to pave the way for the efficient market entry and establish a presence with LIVALO in the statin market in the U.S. and Latin America.”