Tazemetostat, an epigenetic drug, is close to FDA's approval of $330 million in copyright transfer of Weicai

Tazemetostat is a first in class oral EZH2 (zeste gene enhancer homolog 2) inhibitor developed by epizyme company It is clinically developed for the treatment of epithelioid sarcoma, follicular lymphoma and other indications In March 2011, Weicai and epizyme signed a global strategic cooperation on the discovery and development of epigenetic drugs based on EZH2 technology platform, paying a prepayment to the latter and bearing the research and development costs of candidate drugs of the platform before the human conceptual verification stage In March 2015, the two sides amended and supplemented the cooperation agreement Weicai was responsible for the development and commercialization of tazemetosat in Japan, and paid the royalties based on the sales volume of tazemetosat in Japan to epizyme Epizyme is responsible for the development and commercialization of tazemetostat in other parts of the world outside Japan, and it is required to pay the royalties of development, registered mileage and sales revenue based on the regions outside Japan to Weicai Tazemetostat structure On November 5, royalty Pharma, an institution specializing in drug patent licensing revenue investment, announced that it would purchase the global copyright of tazemetosat outside Japan for us $330 million, including US $110 million down payment and US $220 million mileage Fund approved by FDA based on specific indications In addition, royalty Pharma will make an equity investment of US $100 million to epizyme at a price of US $15 / share, and has the right to purchase an additional US $100 million of epizyme's public offering shares in the future Tazemetostat is the core drug in the research of epizyme, a well-known company in the field of epigenetics It has submitted a listing application to the FDA on July 23 this year for accelerated approval, and has obtained the FDA's priority review qualification for metastatic or locally advanced epithelioid sarcoma that is not suitable for treatment The application is based on the data of a single arm, phase II study conducted in 62 patients with epithelioid sarcoma, which was published at asco2019 conference, proving that tazemetostat treatment has achieved clinical significance, long-term remission, and good safety and tolerance The results showed that as of September 17, 2018, the orr of 62 patients was 15%, the median duration of remission (DOR) was not reached, the disease control rate (DCR) was 26%, and the median OS was 82.4 months Among the 62 patients, 24 were initially treated and 38 were relapsed / refractory Among them, the orr was 25%, DOR was 41.1 months, DCR was 42%, median OS was not achieved; the orr of relapsed / refractory patients was 8%, DOR was not achieved, DCR was 16%, median OS was 47.4 months In order to be fully approved after listing, epizyme also plans to launch a global confirmatory, randomized and controlled clinical trial, which will involve about 150 patients with epithelioid sarcoma, and evaluate the efficacy and safety of the combination of tazemetostat and doxorubicin compared with placebo and doxorubicin.