USFDA Approval of Genentech’s RITUXAN HYCELA, A Subcutaneous Rituximab Coformulated With Halozyme ENHANZE Technology

Halozyme Therapeutics, Inc., a biotechnology company developing novel oncology and drug-delivery therapies, today announced that the U.S. Food and Drug Administration (FDA) has approved Genentech’s RITUXAN HYCELA, a combination of rituximab and Halozyme’s hyaluronidase human ENHANZE® technology, for subcutaneous injection in multiple blood cancer indications.

RITUXAN HYCELA has been approved for patients with follicular lymphoma, diffuse large B-cell lymphoma and chronic lymphocytic leukemia, and is expected to be available within one to two weeks. Including all approved indications, Roche reported total 2016 sales of rituximab in the United States of approximately $3.9 billion. Across all of its global collaboration and licensing agreements, Halozyme earns on average a mid-single-digit royalty on sales of products using the ENHANZE technology.