Isofol Medical AB, Sweden has announced that it entered into a license agreement with Solasia Pharma K.K, a specialized oncology company headquartered in Japan, to develop and commercialize Isofol's proprietary late-stage drug candidate arfolitixorin in Japan.

Under the terms of the agreement, Isofol will receive a total amount of ~$ 100 million* (SEK 890 million*) as upfront, development, regulatory and sales-based milestone payments and clinical development cost. In addition, Isofol will receive tiered royalties on net sales in solid double digit figures.

The license agreement is initially focused on the development and commercialization of arfolitixorin as first-line treatment for metastatic colorectal cancer (mCRC) patients in Japan, which is projected to be the second largest addressable patient market for arfolitixorin.

Additional indications will be evaluated jointly by Solasia and Isofol. Isofol retains rights to arfolitixorin in the rest of the world.

Isofol's drug candidate arfolitixorin is being evaluated in the ongoing global Phase 3 AGENT study, as a first-line treatment for mCRC. The study is currently being conducted in the U.S., Canada, Europe, Australia and Japan. On February 18, Isofol announced that the first patient in Japan had initiated treatment in the AGENT study. Isofol together with Solasia plans to expand the study with additional sites in Japan, in addition to the 90 clinics that are already open worldwide.