On August 13, 2020 Isofol Medical AB (publ) ("Isofol"), (Nasdaq First North Premier Growth Market: ISOFOL) reported that it entered into a license agreement with Solasia Pharma K.K ("Solasia") (TSE: 4597), a specialized oncology company headquartered in Japan, to develop and commercialize Isofol’s proprietary late-stage drug candidate arfolitixorin in Japan (Press release, Isofol Medical, AUG 13, 2020, View Source [SID1234563556]). 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.

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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.

"This agreement represents an important next step for the development and commercialization of arfolitixorin. This is Isofol’s biggest milestone yet in the development process of our proprietary drug candidate and a strong validation from a specialized innovative oncology partner in the local Japanese market. Solasia’s proven capabilities to develop and commercialize oncology treatments in Japan and other Asian markets as well as their commitment to cancer patients make them the ideal partner to support our development and commercialization efforts in Japan," said Ulf Jungnelius, M.D, CEO of Isofol.

Isofol will remain as global sponsor of the AGENT study and Solasia will supervise clinical development activities in Japan and be responsible for registrational filing, and following potential regulatory approvals, Solasia will, as the Market Authorization holder, be responsible for the commercialization of arfolitixorin in Japan. Furthermore, Solasia will pay solid double digit tiered royalty rates on future net sales applicable for the deal.

"Arfolitixorin is an important addition to our expanding portfolio of innovative oncology therapies. Japan is the second largest market for arfolitixorin with more than 150,000** people diagnosed with CRC annually. We look forward to working collaboratively with Isofol to accelerate our goal of bringing a new treatment option to patients living with mCRC in Japan," said Yoshihiro Arai, President & CEO of Solasia.
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.

* The total value of upfront, development, regulatory, sales-based milestone payments and clinical development cost is up to JPY 10.4 billion. The amount given in USD and SEK is subject to exchange rate.

** Source: Center for Cancer Control and Information Services, National Cancer Center

Isofol was advised on the transaction by Shadow Lake Group Inc., and the Setterwalls lawfirm.

Invitation to a conference call and webcast on August 13, 2020 at 11:00 (CEST)
Isofol invites investors, analysts and media to a conference call in connection with the licensing agreement with Solasia. The presentation will be held by CEO Ulf Jungnelius in English and will conclude with a Q&A session. Questions can be asked on the telephone conference or in written form through the webcast. No preregistration is needed.

This information is information that Isofol Medical AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 08:30 CEST on August 13, 2020.