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Kyowa Hakko to develop and commercialize Syndax’s entinostat in Japan and Korea

Kyowa Hakko Kirin (KHK) has entered into a license agreement for the exclusive rights to develop and commercialize Syndax Pharmaceuticals' entinostat in Japan and Korea.

Currently, Syndax is developing entinostat, a Class I selective histone deacetylase (HDAC) inhibitor, in the US and Europe in combination with hormone therapy for advanced breast cancer and immune therapy combinations in solid tumors.

As part of the deal, Kyowa will pay Syndax a total of $100m including an upfront fee of $25m with a certain amount of an equity investment and potential development and commercial milestone payments.

Kyowa Hakko Kirin Strategic Product Portfolio Department executive officer, director, Masashi Miyamoto said: "Entinostat has great potential to treat a cancer with a mode of action modifying epigenetics.

"We believe that Entinostat could deliver a lot of benefit to breast and other cancer patients, which lead to strengthen KHK’s future oncology portfolio."

During the term of the agreement, Syndax will be responsible for manufacturing and supplying the product to Kyowa.

Syndax president and chief executive officer Arlene Morris said: "Since we have already begun a registration-directed Phase 3 trial in breast cancer in the US, it’s important and timely to enter into this agreement with KHK to initiate development in order to bring entinostat to breast cancer patients in Japan and Korea.

"The expansion of the global development effort further validates the importance of prolonging survival in metastatic breast cancer as observed in our Phase 2 trial and underscored by the FDA designating entinostat a Breakthrough Therapy when combined with exemestane in postmenopausal women with HR+ metastatic breast cancer."

The biopharmaceutical firm Kyowa Hakko Kirin is planning to commence clinical trials in 2015.