Japan's Eisai sold the worldwide rights, excluding Japan, to Phase I/II cancer candidate EP-6438 to U.S.-based Epizyme ($EPZM) for $40 million upfront, revising a 2011 agreement on discovery, development and commercialization of a therapy aimed at non-Hodgkin B-cell lymphoma and other cancers.
Eisai has conducted a Phase I/II clinical study of the EZH2 inhibitor in patients with advanced solid tumors or non-Hodgkin B-cell lymphoma under the 2001 agreement.
But the terms were changed at the behest of Epizyme, which will assume responsibility for development and commercialization in regions outside of Japan while Eisai retains responsibility for development and commercialization within Japan as well as having the right of first negotiation for licensing rights in Asia.
Epizyme President and CEO Robert Gould said his company approached Eisai to reacquire the rights after EPZ-6438 demonstrated durable responses in early stage trials in a "broader patient population than originally anticipated," including in non-Hodgkin's lymphoma (NHL) patients with wild-type EZH2 and patients with non-germinal-center lymphoma.
Epizyme intends to start Phase II testing in NHL patients in Europe in 2Q15 and in adult and pediatric patients with SMARCB1-deficient tumors in 2H15.
In addition to the upfront, the Japanese pharma is eligible for up to $20 million in clinical milestones, up to $50 million in regulatory milestones and mid-teen royalties on ex-Japan sales. Epizyme is eligible for mid-teen royalties on sales in Japan.
Epizyme will fund all global development costs while Eisai will fund all Japan-specific development costs. Eisai will have a limited right of first negotiation for Asia rights if Epizyme decides to license those rights to a third party.
Epizyme received $6 million upfront and $33 million in milestones from Eisai under the original 2011 deal. The biotech had $190.1 million in cash at Dec. 31.
- here's the Epizyme release
- and the Eisai release