Knight Therapeutics and Incyte Amend Supply and Distribution Agreement to Add Retifanlimab and Axatilimab in Latin America

Executive Summary

• Knight Therapeutics Inc. has amended its existing agreement with Incyte Biosciences International Sàrl to expand their partnership, granting Knight exclusive rights to distribute retifanlimab (ZYNYZ®) and axatilimab (NIKTIMVO™) in Latin America.
• Under the amended terms, Incyte retains responsibility for the development, manufacture, and supply of the drugs, while Knight is responsible for securing regulatory approvals and handling distribution within the region.
• This expansion builds upon a previous exclusive supply and distribution agreement established in September 2021 for MINVUVI® (tafasitamab) and PEMAZYRE® (pemigatinib) in Latin America.

Key Details

• Parties Involved: Knight Therapeutics Inc. (TSX: GUD) and Incyte Biosciences International Sàrl (affiliate of Incyte, NASDAQ: INCY).
• Product 1: Retifanlimab (ZYNYZ®)
  • Indications: Approved in the U.S. and Europe for metastatic/recurrent locally advanced Merkel cell carcinoma (MCC) and in combination with carboplatin/paclitaxel for first-line treatment of inoperable locally recurrent or metastatic squamous cell carcinoma of the anal canal (SCAC). Also approved as a single agent for SCAC with disease progression on platinum-based chemotherapy.
  • Market Potential: Estimated 550–1,250 new MCC cases annually in Brazil, Mexico, Colombia, and Argentina; approximately 2,700–4,000 new SCAC cases annually in the same region.
• Product 2: Axatilimab (NIKTIMVO™)
  • Indication: FDA-approved (August 2024) for chronic graft-versus-host disease (cGVHD) after failure of at least two prior lines of systemic therapy in adult and pediatric patients weighing at least 40 kg.
  • Market Potential: Approximately 1,400–1,800 reported allogeneic transplants in Brazil annually.
  • Pipeline: Being studied in Phase 2 combination trials with ruxolitinib (NCT06388564) and Phase 3 combination trials with steroids; also in Phase 2 trial for idiopathic pulmonary fibrosis (NCT06132256).
• Previous Agreement: Knight and Incyte previously entered an exclusive supply and distribution agreement in September 2021 for MINVUVI® (tafasitamab) and PEMAZYRE® (pemigatinib) in Latin America.
• Strategic Impact: Knight aims to strengthen its presence in oncology and hematology, leveraging its extensive track record and distribution capabilities in Latin America.

Notable Quotes

• Samira Sakhia, President and CEO of Knight Therapeutics: “We are thrilled to expand our partnership with Incyte and for the opportunity to bring two innovative biologic products to the LATAM region... These therapies are highly complementary to our existing portfolio and will significantly strengthen our presence in oncology and hematology, reinforcing our commitment to delivering transformative treatments to patients across Latin America.”
• Lee Heeson, Executive Vice President and Head of Incyte International: “As a partner, Knight, has an extensive track record of successful collaborations as well as strong distribution capabilities in Latin America... We look forward to continuing to work together and to expanding our existing partnership for tafasitamab and pemigatinib to include retifanlimab and axatilimab so that eligible patients in the region can access our innovative medicines.”