On March 22, 2023 MacroGenics, Inc. (NASDAQ: MGNX), a biopharmaceutical company focused on developing and commercializing innovative antibody-based therapeutics for the treatment of cancer, reported that following the U.S. Food and Drug Administration’s (FDA) approval of Incyte’s Biologics License Application (BLA) for ZYNYZ (retifanlimab-dlwr), the Company will receive a $15 million milestone payment from Incyte. ZYNYZ, a humanized monoclonal antibody targeting programmed death receptor-1 (PD-1), was previously developed by MacroGenics and licensed to Incyte pursuant to an exclusive global collaboration and license agreement in October 2017 (Press release, MacroGenics, MAR 22, 2023, View Source [SID1234629161]).
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"The FDA approval of ZYNYZ represents the third approval of a product originating from MacroGenics’ pipeline of proprietary or partnered product candidates," said Scott Koenig, M.D., Ph.D., President and Chief Executive Officer of MacroGenics. "We are delighted that with the approval of ZYNYZ, there is now an additional option for treating patients with Merkel cell carcinoma, a rare and aggressive type of skin cancer. We also look forward to Incyte’s continued progress in advancing their development of retifanlimab across additional indications and geographies."
Under the terms of the license agreement, beyond the $15 million approval milestone, MacroGenics is also eligible to receive up to a total of $320 million in potential remaining development and regulatory milestones and up to $330 million in potential commercial milestones from Incyte. In addition, MacroGenics is eligible to receive tiered royalties of 15% to 24% on any global net sales of the product. Finally, MacroGenics has an agreement with Incyte under which it manufactures a portion of Incyte’s global commercial supply of retifanlimab.