X4 Pharmaceuticals and Norgine Enter into Exclusive Licensing Agreement to Commercialize Mavorixafor in Europe, Australia, and New Zealand

Licensing and Financial Terms - X4 Pharmaceuticals will receive an upfront payment of €28.5 million and up to €226 million in potential regulatory and commercial milestone payments, in addition to tiered, double-digit royalties up to the mid-twenties [1] - The upfront non-dilutive funds will strengthen X4's balance sheet as enrollment ramps up in the company's global Phase 3 clinical trial in chronic neutropenia [1] - X4 and Norgine will collaborate closely on regulatory filings, with X4 continuing to be responsible for the ongoing global, pivotal Phase 3 4WARD clinical trial evaluating mavorixafor in chronic neutropenia [7] Strategic Partnership and Market Expansion - Norgine will commercialize mavorixafor in Europe, Australia, and New Zealand following regulatory approvals [1] - The agreement underscores Norgine's commitment to bring transformative therapies to patients in need in these key strategic territories [1] - Norgine will be responsible for all market access and commercialization activities and will eventually hold all marketing authorizations in the licensed territories [7] Product Development and Regulatory Progress - Mavorixafor is a selective CXCR4 receptor antagonist approved in the U.S. and marketed by X4 as XOLREMDI®, an oral, once-daily treatment for patients 12 years of age and older with WHIM syndrome [4] - X4 expects to announce shortly the submission of a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for mavorixafor in the treatment of WHIM syndrome [4] - X4 is also developing mavorixafor to treat chronic neutropenia (CN) and is currently conducting a global, pivotal Phase 3 clinical trial in certain CN disorders [4] Company Profiles - X4 Pharmaceuticals is focused on developing and commercializing innovative therapies for rare diseases of the immune system, leveraging expertise in CXCR4 and immune system biology [2] - Norgine is a specialty pharmaceutical and consumer healthcare company with more than €500 million of annual revenues and a 120-year track record of bringing life-changing products to patients and consumers across Western Europe, Australia, and New Zealand [5] Executive Commentary - Paula Ragan, Ph.D., President and CEO of X4 Pharmaceuticals, highlighted the strategic agreement as a significant milestone for maximizing the global potential of mavorixafor and funding the ongoing Phase 3 trial in chronic neutropenia [7] - Janneke van der Kamp, CEO of Norgine, emphasized the partnership's role in expanding access to mavorixafor for patients in Europe, Australia, and New Zealand, and Norgine's position as a partner of choice in these regions [7]