Pharma Focus Asia

Agios and CStone Pharmaceuticals Announce Exclusive Collaboration and License Agreement

Friday, November 16, 2018

Agios Pharmaceuticals, Inc., a leader in the field of cellular metabolism to treat cancer and rare genetic diseases, and CStone Pharmaceuticals, a privately-held biopharmaceutical company devoted to developing a new generation of innovative drugs, today announced an exclusive collaboration and license agreement for the development and commercialization of ivosidenib (TIBSOVO®; AG-120) in Mainland China, Hong Kong, Macau and Taiwan (“Territory”), either as a monotherapy or in combination with other therapies. Discovered and developed by Agios, ivosidenib is an investigational, first-in-class, oral, targeted inhibitor of the mutant isocitrate dehydrogenase-1 (IDH1) enzyme. CStone Pharmaceuticals will be responsible for conducting the development and commercialization activities for ivosidenib in hematologic and solid tumor indications in the Territory, with an initial focus in acute myeloid leukemia (AML) and cholangiocarcinoma. Agios will retain all rights to ivosidenib in the rest of the world.

“CStone Pharmaceuticals brings together a highly experienced leadership team and drug development capabilities that will enable us to reach patients with IDH1 mutant cancers in Greater China who could benefit from ivosidenib,” said David Schenkein, M.D., chief executive officer at Agios. “In addition to the clinical development activities that CStone will be leading, we also have the opportunity to leverage CStone’s network to expand our ongoing and future global clinical trials of ivosidenib into Greater China.”

Subject to the terms of the agreement, Agios will receive an upfront payment of $12 million and will be eligible to receive up to $412 million in milestone payments, of which $147 million are related to development and regulatory events and $265 million to the achievement of certain sales levels. Approximately half of the milestone payments are related to the development and commercialization of ivosidenib in AML, cholangiocarcinoma and other potential indications. The other half are payable only if development and commercialization of ivosidenib in brain cancer indications, including glioma, are pursued as part of the collaboration at a later date. In addition, CStone Pharmaceuticals will pay Agios tiered royalties ranging from the mid to high-teens as a percentage of annual net sales of ivosidenib in the Territory. CStone Pharmaceuticals will be responsible for all costs associated with development and commercialization activities for ivosidenib conducted in the Territory under the agreement.

“We’re very pleased to partner with Agios to advance the global development of ivosidenib, which has clearly demonstrated significant benefit to patients with AML as well as potential utility in other IDH1m cancers,” said Frank Jiang, M.D., Ph.D., chief executive officer at CStone Pharmaceuticals. “Given ivosidenib is currently under U.S. FDA priority review for IDH1m relapsed or refractory AML patients, it is the most advanced program in our pipeline. The partnership will also allow us to explore ivosidenib in combination with other products in our portfolio.”

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