Epizyme and Hutchmed Form Strategic Collaboration to Develop and Commercialize Tazverik in Greater China

Hutchmed will pay Epizyme up to $310 million as part of a collaboration to develop and commercialize Tazverik in Greater China for the treatment of a range of cancers.

Tazverik is a methyltransferase inhibitor of EZH2 developed by Epizyme that is approved by the U.S. Food and Drug Administration for the treatment of certain patients with epithelioid sarcoma (ES) and certain patients with follicular lymphoma (FL). It was approved under FDA accelerated approval based on overall response rate and duration of response in January for ES and in June 2020 for FL.

Under the terms of the agreement, Hutchmed will be responsible for the development and commercialization of Tazverik in greater China. Epizyme will receive $25 million upfront and is eligible to receive up to an additional $110 million in development and regulatory milestone payments, across up to eight potential indications, and up to an additional $175 million in sales milestone payments.

Epizyme is also eligible to receive tiered royalties of mid-teen to low-twenties-percent based on annual net sales of Tazverik in Greater China. In addition, Hutchmed receives a four-year warrant to acquire up to $65 million of Epizyme shares at $11.50 per share. The upfront payment will be funded by Hutchmed from existing cash resources, and potential milestone payments and royalties are expected to be funded from future cash resources including cash from the sales of Tazverik.

“Hutchmed is an ideal partner for us in Greater China, given their development and commercial expertise and shared commitment to expanding the value of Tazverik through new clinical trials that complement Epizyme’s development plans,” said Robert Bazemore, Epizyme president and CEO. “Through this collaboration we anticipate Tazverik to become the first EZH2 inhibitor brought to market in Greater China, and we believe the involvement of Hutchmed in the global development of Tazverik can allow for a more rapid, resource-efficient, and geographically inclusive development plan for the U.S. confirmatory EZH-302 trial of Tazverik in second line follicular lymphoma (2L FL) in combination with Revlimid plus rituximab (R²).”

Christian Hogg, CEO of Hutchmed, said the company believes the activity of Tazverik and its epigenetic mechanism in controlling the expression of certain genes is highly complementary and potentially synergistic with its broad portfolio of novel oncology assets.

“Tazverik’s potential for broad applicability and favorable safety profile may provide further inhibition of tumor growth and metastasis when used in combination therapy,” he said. “This collaboration will accelerate the exploration of the clinical potential of EZH2 inhibition in multiple tumor types, including both hematological malignancies and solid tumors. We believe that Epizyme and Hutchmed are uniquely positioned to realize these opportunities and thereby rapidly benefit as many patients, both inside and outside China, as possible.”

Hutchmed plans to develop and seek approval for Tazverik in various hematological and solid tumors, including ES, FL and diffuse large b-cell lymphoma in its territory. Hutchmed will also participate in Epizyme’s global registrational study of Tazverik in combination with R² in second line FL, the EZH-302 study, and lead the study in Greater China.

The parties also intend to conduct additional global studies jointly. Hutchmed will generally be responsible for funding all clinical trials of Tazverik in its territory including the portion of global trials conducted therein. Upon any approvals Hutchmed will be responsible for commercialization in its designated territory. Hutchmed will also hold rights to the research and manufacture of Tazverik in the territory.

Author: Rare Daily Staff