Halozyme provides update on EPO decision regarding Darzalex

Halozyme Therapeutics provides an update on a decision by the Opposition Division of the European Patent Office, or EPO, regarding one of the Janssen Biotech co-formulation patents for DARZALEX. "We remain confident in our strong royalty revenue potential across our diverse partner pipeline. Today’s decision in Europe on a single co-formulation patent has no impact on our current FY23 revenue guidance. Janssen will continue to pay royalties to Halozyme on U.S. and European sales of DARZALEX FASPRO and SC, in line with our total royalty revenue projection of approximately $1B by 2027, and thereafter to at least 2030. We also do not believe this decision will impact the ability of any other Halozyme licensee to obtain co-formulation patents for their innovations. Furthermore, today’s decision has no impact on the composition of matter patents in the U.S. and Europe for ENHANZE," said Helen Torley, president and CEO. "We are disappointed with the Opposition Division’s oral decision to revoke Janssen’s European Patent EP3370770B1. We expect a written decision to be provided in the next several months. If an appeal is filed, it would suspend today’s decision and the patent would remain in force until the case is finally decided on any such appeal," concluded Torley.