Ono Pharmaceutical Co, Ltd. and Merck & Co., Inc. 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.
Under the terms of the agreement, Ono will receive an initial payment and milestone payments in addition to royalties on net sales. 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.
"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," he added.
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," Dr. Peter S. Kim, president of Merck Research Laboratories said adding, "We are delighted about our agreement with Ono, which has earned a global reputation for its leadership in the development of novel new drugs."
Dr. Shozo Matsuoka, executive director at Development Headquarters at Ono said, "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.
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.