Epigenetic drug Tazemetostat nears FDA approval for $330 million transfer of copyright

Tazemetostat StructuredNovember 5, Royalty Pharma, which specializes in investment in the proceeds of drug patent licensing, announced the purchase of global rights outside Japan from Vesa for $330 million, including a $110 million down payment and $220 million in FDA mileage approvals based on specific indicationsIn addition, Royalty Pharma will invest $100 million in Epizyme's equity at $15 a share and will be entitled to an additional $100 million in Epizyme's public offering in the futureTazemetostat, a well-known epigenetics company at the heart of Epigenetics, has filed a listing application with the FDA on July 23 for accelerated approval and has been qualified for FDA's priority review for metastatic or localized advanced epithelial sarcoma that is not suitable for curative surgeryThe application was based on data from a single arm, Phase II study conducted in 62 patients with epidermal sarcoma, which was presented at the ASCO 2019 conference and demonstrated that tazemetostat treatment achieved clinically significant, long-lasting relief and good safety and toleranceresults show that as of September 17, 2018, 62 patients had 15% ORR, median remission duration (DoR) was not reached, disease control rate (DCR) was 26%, and median OS was 82.4 monthsThe 62 patients included 24 first-treatment patients and 38 recurrent/difficult-treating patientsAmong them, the ORR of primary treatment patients was 25%, the DoR was 41.1 months, the DCR was 42%, the median OS was not reached, the ORR was 8%, the DoR was not reached, the DCR was 16%, and the median OS was 47.4 monthsin order to go public and become fully approved, Epizyme also plans to launch a global validation, randomized, controlled clinical trial, planning to enroll about 150 patients with epidermal sarcoma in a group of about 150 patients to assess the efficacy and safety of the tazemetostat and doxorubicin combination drug regimen compared to the placebo and amycin regimenDrTakashi Owa, Vice President and Chief Medical Innovation Officer,, said, "The global copyright transfer of tazemetostat is primarily for funding to support the development of more innovative therapies in the Aishi product pipeline"