EXCERPT

GOTHENBURG, Sweden, Nov. 2, 2020 /PRNewswire/ — Isofol Medical AB (publ) (“Isofol”), (Nasdaq First North Premier Growth Market: ISOFOL) is pleased to announce today a definitive license agreement with Endo Ventures Limited, a subsidiary of Endo International plc (NASDAQ: ENDP) plc, for the registration and commercialization of arfolitixorin on an exclusive basis in Canada. With the consent of Isofol, Endo Ventures Limited has designated Paladin Labs Inc., an operating company of Endo, to be responsible for seeking regulatory approval for arfolitixorin in Canada and after receipt of such approval, to be responsible for the commercialization of arfolitixorin in Canada, including distribution, marketing, medical affairs, pricing and reimbursement activities. Isofol may receive up to $US 23.05 million** (SEK 205 million**) as upfront, development, regulatory and sales-based milestone payments. In addition, Isofol will receive tiered royalties on net sales in solid double-digit figures.

The license agreement is focused on the registration and commercialization of arfolitixorin as first-line treatment for metastatic colorectal cancer (mCRC) patients in Canada. Isofol will be responsible for supplying the drug to Endo and will retain all international development rights.  

“This licensing agreement between Isofol and Endo is a strong validation of the potential for arfolitixorin to address the large unmet medical need for patients treated for CRC. The collaboration will allow Canadian patients access to arfolitixorin upon receipt of the requisite regulatory approval, advancing the treatment regimens of difficult to treat cancers and also demonstrates our commitment to advance the quality of cancer care worldwide. Endo, through Paladin, has a very successful track record of commercializing innovative pharmaceutical products in Canada and our collaboration with them will be an invaluable component of our strategy to ensure global access to arfolitixorin,” said Ulf Jungnelius, M.D, CEO of Isofol.

Isofol will remain as global sponsor of the AGENT study and Endo will be responsible for registrational filing and pursuing potential regulatory approval. Paladin will, as the Market Authorization holder, be responsible for the commercialization of arfolitixorin in Canada. Furthermore, Isofol will receive solid double-digit tiered royalty rates on future net sales applicable for the deal.

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

Read full news release here.