On November 2, 2020 Isofol Medical AB (publ) ("Isofol"), (Nasdaq First North Premier Growth Market: ISOFOL) reported 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 (Press release, Isofol Medical, NOV 2, 2020, View Source [SID1234569744]). 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.
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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.
"Arfolitixorin is an important addition to our portfolio of innovative oncology therapies," said Livio Di Francesco, Vice President and General Manager of Paladin. "Colorectal cancer is the third most common cancer affecting nearly 27 thousand Canadians annually***. Paladin is dedicated to bringing new treatment options to Canadians, such as arfolitixorin, which could potentially provide an additional therapeutic option to patients undergoing chemotherapy treatment for metastatic colorectal cancer."
Isofol’s drug candidate arfolitixorin is being evaluated in the ongoing global Phase III AGENT study, as a first-line treatment for mCRC. The study is currently being conducted in the U.S., Canada, Europe, Australia and Japan in over 90 clinics that are open worldwide.
** The amount given in SEK is subject to exchange rate
*** Canadian Cancer Society (www.cancer.ca/en/cancer-information/cancer-type/colorectal/statistics)
Isofol was advised on the transaction by Shadow Lake Group Inc., and Setterwalls Law Firm.
Invitation to a conference call and webcast on November 2, 2020 at 15:00 (CET)
Isofol invites investors, analysts and media to a conference call in connection with the licensing agreement with Endo/Paladin. 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.