Herceptin Hylecta (trastuzumab and hyaluronidase-oysk) subcutaneous (SC) fixed-dose combination drug from Genentech, which received approval from the US Food and Drug Administration (FDA) at the end of last week.
A spokesperson for Genentech told us, “Herceptin Hylecta includes the same monoclonal antibody as intravenous Herceptin (trastuzumab) in combination with recombinant human hyaluronidase PH20, an enzyme that helps to deliver trastuzumab under the skin.”
Halozyme licensed its Enhanze technology to Roche for $25m (€22m) in October 2018 – shortly after Genentech's Herceptin SC, the Canadian brand name of Herceptin Hylecta, which uses the proprietary drug-delivery technology, was approved for the treatment of patients with HER2-positive breast cancer by Health Canada.
Enhanze is a drug-delivery technology that uses PH20 to temporarily degrade hyaluronan, a chain of natural sugars in the body, to aid dispersion and absorption of injected drugs.
The SC fixed-dose formulation can be administered in two to five minutes, whereas intravenous (IV) Herceptin requires 30 to 90 minutes.
At the time of Herceptin SC’s approval, Helen Torley, CEO of Halozyme, told us, “In the countries where it has been launched, the subcutaneous version was recently reported by Roche, at peak, to account for 60% of total sales volume, with IV Herceptin accounting for 40%.”
Halozyme’s pharma partners
Roche and Halozyme have been collaborating in licensing agreements for Enhanze since 2006. Roche has used the technology in multiple drugs including Rituxan (rituximab).
Bristol-Myers Squibb also collaborated with Halozyme in 2017 to develop 11 immuno-oncology drugs for SC administration.
Halozyme has licensed the technology to eight leading pharmaceutical and biotech companies including Pfizer, Janssen, and AbbVie.