A Dutch court has barred Merck from selling its subcutaneous version of Keytruda in several European countries, ruling that the drug infringes on Halozyme Therapeutics' patent for rapid under-the-skin injection technology. Both BioPharma Dive and STAT report the decision, with STAT noting Merck said it "strongly" disagreed. Halozyme said the ruling strengthens its position and could lead to a license or other economic resolution, according to a TD Cowen analyst cited by BioPharma Dive.
The two sources differ on the scope of the ban. BioPharma Dive says the court blocked sales in eight European countries, while STAT lists France, Italy, Sweden, Switzerland, and the Netherlands and describes the ban as covering "several" countries. STAT also emphasizes that patients can still access the existing intravenous version of Keytruda, which is not part of the dispute. BioPharma Dive adds that Halozyme has already won a related case in Germany and is pursuing litigation in the U.S., and that Bristol Myers Squibb and Roche licensed the same technology for their own subcutaneous immunotherapies.
BioPharma Dive's roundup also includes several items not covered by STAT: Enliven Therapeutics aligned with the FDA on a late-stage trial design for its chronic myeloid leukemia drug relcobatinib; Insmed's CFO is stepping down; KymaThera raised $80 million for a PI3Kα-targeting treatment; and RougeTx launched with $58 million for a rare bleeding disorder therapy. These are unrelated to the Merck-Halozyme dispute.