Eli Lilly and Kowa Pharmaceuticals America to co-promote LIVALO in the U.S

Eli Lilly and Company (NYSE: LLY), Kowa Company, Limited, and Kowa's U.S. subsidiary, Kowa Pharmaceuticals America, Inc., today announced that Lilly and Kowa Pharmaceuticals America have entered into a co-promotion agreement in the United States to commercialize LIVALO® (pitavastatin). Lilly and Kowa have also entered into a licensing agreement in Latin America. LIVALO is a statin approved by the U.S. Food and Drug Administration (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 LIVALO in the U.S. market, with both companies providing sales force resources and sharing development and marketing costs. Kowa Pharmaceuticals America will record all U.S. sales of LIVALO and will pay Lilly an escalating co-promotion fee based on the level of annual net sales. In addition, Lilly has acquired an exclusive license from Kowa to commercialize LIVALO in Latin American markets, including Mexico, Central America and South America. Additional deal 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."

"Physicians are challenged by some patients who do not always do well on their current statin therapy, and who also must deal with potential interactions with other medications. LIVALO offers a new statin option, with LDL lowering consistent with the commonly administered doses of Lipitor® and Zocor®, and significantly greater LDL lowering in the elderly compared to Pravachol®," stated LeRoy LeNarz, M.D., senior medical director at Lilly.

"It is with great pleasure that we partner with an internationally-renowned company like Lilly," said Yoshihiro Miwa, Kowa president and CEO. "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."

"We are excited to partner with Lilly as we work to establish the LIVALO brand and expand Kowa Pharmaceuticals America's presence in the U.S. market," said Ben Stakely, president and CEO of Kowa Pharmaceuticals America.