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Gilead Sciences and Lakefront Complete Acquisition of Ouro Medicines to Further Expand Inflammation Pipeline

GILDLKFT
  • Gilead Sciences & Lakefront Biotherapeutics completed the acquisition of Ouro Medicines to advance T cell engager therapies for autoimmune diseases.
  • The transaction adds gamgertamig (OM336), a clinical-stage BCMAxCD3 T cell engager, to Gilead's inflammation portfolio & establishes the foundation of Lakefront's clinical pipeline.
  • Gamgertamig targets severe antibody-mediated diseases like autoimmune hemolytic anemia (AIHA) & immune thrombocytopenia (ITP) with potential for durable disease control via limited subcutaneous treatment.
  • The U.S. FDA granted Fast Track & Orphan Drug Designations for gamgertamig in AIHA & ITP, with registrational studies expected to begin as early as 2027.
  • Gilead acquired Ouro Medicines for $1.675 billion upfront plus up to $500 million in contingent milestone payments.
  • Gilead & Lakefront will equally split the upfront payment & share the contingent milestone payments, subject to customary adjustments.
  • Lakefront acquired Ouro Medicines' team & operational assets & will collaborate with Gilead on gamgertamig development.
  • Lakefront is responsible for ongoing & future Phase 1/2 clinical studies of gamgertamig, while Gilead will lead registrational & later-stage studies.
  • Gilead retains sole worldwide commercialization rights for gamgertamig outside of Keymed's territories & will cover all related costs.
  • Lakefront will receive tiered royalties of 20%–23% on net sales of gamgertamig from Gilead.
  • Lakefront in-licensed three additional preclinical autoimmune programs from Ouro with an opt-in for Gilead for a 50/50 profit split post clinical proof-of-concept for $75 million per program.
  • The transaction provides relief under the July 2019 Option, License & Collaboration Agreement to allow Lakefront to deploy at least $500 million of cash independently, including up to $150 million for share buybacks.
  • Lakefront expects a year-end 2026 cash balance of approximately €2 billion to support future strategic transactions & capital allocation priorities.
  • Gamgertamig is in-licensed from Keymed Biosciences, which retains development rights in Greater China.
  • Lakefront Biotherapeutics was formerly known as Galapagos & focuses on oncology & immunology programs with clear clinical proof-of-concept.