Ono Pharmaceutical Co., Ltd. Signs Agreement Granting Merck & Co., Inc. Worldwide License for the Injectable Formulation of ONO-2506, a Novel Compound for Stroke

Business Wire, Nov 10, 2004

OSAKA, JAPAN & WHITEHOUSE STATION, N.J. -- Ono Pharmaceutical Co., Ltd. and Merck & Co., Inc. today announced that they have signed an agreement granting Merck the worldwide license for ONO-2506 ((R)-(-)-2-propyloctanoic acid), a novel intravenous compound currently in Phase II development for the treatment of acute stroke. Stroke is a leading global killer and major cause of severe disability.

"We are delighted to be partnering with Ono, which has an outstanding record in Japan for discovering and commercializing innovative medicines," said David W. Anstice, president of Human Health for Merck, whose responsibilities include Japan. "Merck recognizes the valuable scientific medical achievements being made in Japan today and is committed to working with Ono to bring the benefits of their research to patients globally."

Under the terms of the agreement, Ono will receive an initial payment and milestone payments in addition to royalties on net sales. Additional financial terms were not disclosed.

In addition, Ono will receive exclusive rights in Japan to develop and market EMEND (aprepitant), Merck's drug for use in combination with other antiemetic agents for prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy, including cisplatin. Ono also receives rights in Japan to co-market a second brand of MK-431, Merck's investigational oral compound for the treatment of diabetes, under a yet to be determined trademark.

Ono retains rights to the injectable formulation of ONO-2506 in Japan, Korea and Taiwan. Ono also retains worldwide rights to other formulations of ONO-2506.

"We believe intravenous ONO-2506 has the potential to be a new therapeutic option for doctors in the treatment of stroke, a leading global killer and major cause of severe disability," said Dr. Peter S. Kim, president of Merck Research Laboratories. "We are delighted about our agreement with Ono, which has earned a global reputation for its leadership in the development of novel new drugs."

According to the American Stroke Association (ASA), about 700,000 Americans will have a stroke this year. About 500,000 are first attacks, and 200,000 are recurrent attacks. Stroke is the nation's third leading killer and a major cause of severe, long-term disability. The ASA reports that stroke is expected to be responsible for an estimated $53 billion in direct and indirect medical costs this year alone.

"We expect that the injectable formulation of ONO-2506, a novel drug based on a brand-new concept, may offer an innovative new treatment for stroke," said Dr. Shozo Matsuoka, executive director at Development Headquarters at Ono. "We are very pleased about the partnership with Merck, a leading global pharmaceutical company with a demonstrated expertise in the development and marketing of drugs. Our agreement is a major step forward for the worldwide development of the injectable formulation of ONO-2506, which we hope will lead to the drug's early introduction into the global market."

ONO-2506 has a novel mechanism of action and is believed to inhibit expansion of cerebral infarction by modulating the function of astrocytes, a type of glial cell in the brain. Early studies suggest that ONO-2506 may exhibit a neuroprotective effect by preventing irreversible injury to neurons in the brain.

In contrast, thrombolytic agents such as Activase(R) (alteplase, recombinant; commonly known as t-PA), the only currently approved drug in the United States and Europe for the treatment of acute ischemic stroke in adults, acts by restoring blood flow to the ischemic region. Treatment with t-PA should only be initiated within three hours of the onset of stroke symptoms and after exclusion of intracranial hemorrhage. Only about 2 percent of those who suffer a stroke reach a hospital in time and qualify for treatment with t-PA, underscoring the need for novel new treatments for stroke. Thus, ONO-2506 has the potential to meet a heretofore unmet medical need.

ONO-2506 is being studied to determine if it has a longer therapeutic time window of administration and a lower risk of bleeding than t-PA, as well as to learn if it may have neuroprotective benefits that could reduce the cerebral injury from stroke.

"Merck is very pleased about this opportunity to partner with Ono," said Dr. Merv Turner, senior vice president of Worldwide Licensing and External Research at Merck Research Laboratories. "This agreement is the latest example of Merck's increased focus on complementing our internal research efforts with external licensing of novel therapies that address true unmet medical needs, such as stroke."

About Merck

Merck & Co., Inc. is a global research-driven pharmaceutical company. Merck discovers, develops, manufactures and markets a broad range of innovative products to improve human and animal health, directly and through its joint ventures.

Merck Sharp & Dohme or MSD is the name Merck uses for conducting its business in all other countries outside the United States and Canada, except in Japan, where Merck's subsidiary, Banyu Pharmaceutical Co., Ltd., operates.