September 8, 2010
ONO PHARMACEUTICAL CO., LTD.
President and Representative Director: Gyo Sagara,
Code No.: 4528 at the 1st section of the Tokyo / Osaka Stock Exchange
INQUIRIES: Kinya Morimoto, Managing Director, Corporate Communications

Ono Announces Carfilzomib Development
and Commercialization Agreement with Onyx Pharmaceuticals for Japan

Ono Pharmaceutical Co., Ltd. (Osaka, Japan) today announced that it has entered into an exclusive agreement with Onyx Pharmaceuticals, Inc. (Emeryville, California, USA) to develop and commercialize two compounds from Onyx’s proteasome inhibitor development program, carfilzomib and ONX 0912, in Japan. The compounds are both in clinical development by Onyx outside of Japan. Under the terms of the agreement, Ono has rights to commercialize these two compounds for all oncology indications.

Ono will pay Onyx an upfront payment of JPY 5 billion at closing of the agreement. In addition, Ono will provide development and sales-based payments related to the compounds that could potentially be approximately JPY 24 billion. The agreement also calls for double digit royalties on net sales in Japan.

Meanwhile Onyx retains commercialization rights in other countries in the Asia Pacific region, as well as in all other regions of the world, including USA and Europe.

Carfilzomib, a highly selective proteasome inhibitor, is currently being evaluated in multiple clinical trials for the treatment of patients with multiple myeloma and other cancers. ONX 0912, an oral proteasome inhibitor, is currently in Phase I testing for the treatment of recurrent solid tumors.

In USA, Onyx is preparing a new drug application (NDA) for carfilzomib, which it expects to submit to the Food and Drug Administration (FDA) by year-end 2010. Given this potential timeline, Onyx is engaged in planning and executing prelaunch activities.

“This strategically important transaction underscores the growing interest and excitement surrounding carfilzomib. Ono is an ideal partner in Japan given their focus on highly innovative new pharmaceutical products and their reputation for scientific excellence.” said N. Anthony Coles, M.D., president and chief executive officer of Onyx. “Onyx is committed to reaching all patients with multiple myeloma who could potentially benefit from promising therapies such as carfilzomib and ONX 0912, as quickly as possible. This partnership allows us to benefit from Ono’s drug development experience in Japan for the advancement of carfilzomib, while we focus on execution in the U.S. and Europe.”

“Ono is actively engaged in the development and the commercialization of innovative drugs in cancer and related areas, including Emend® for chemotherapy induced nausea and vomiting and an antibody anticancer drug, as well as drugs for cancer anorexia / cachexia and for opioid-induced constipation, and recognizes the tremendous need for new treatment options for multiple myeloma. This agreement facilitates our strategic expansion of our development pipeline in the oncology area with these exciting new compounds from a proven class of drugs. The promising activity and tolerability observed to date indicate that carfilzomib may be an important new treatment option for myeloma patients, and we look forward to collaborating with Onyx to bring this drug to patients in Japan, as quickly as possible.” said Gyo Sagara, Ono’s President, Representative Director and CEO.

To continue reading, please go to the following page:
http://www.ono.co.jp/eng/si/PDFe/sm_cn100908_2.pdf