Subcutaneous Herceptin formulation was developed using Halozyme technology and is undergoing Phase III trials.
Roche is making a CHF 190 million (about $181.83 million) investment into two European production facilities to allow the commercial-scale manufacture of a patient-friendly device that could allow the subcutaneous self-administration of biological anticancer drugs.
The company is developing a new infusion-free device for delivering a formulation of Herceptin based on Halozyme Therapeutics’ Enhanze™ technology (rHuPH20, recombinant human hyaluronidase). In October 2009, the two companies reported the start of a Phase III trial evaluating this formulation.
Roche claims subcutaneous Herceptin administration takes only about five minutes. The company also suggests that subcutaneous delivery could allow patients to receive Herceptin at their doctor’s clinic or even at home. In contrast, infusion of the drug, which is generally carried out at a hospital, takes about an hour.
“There is also hope that patients will experience fewer infusion reactions due to the slower absorption after subcutaneous administration,” according to Pat Yang, head of Roche Pharma Global Technical Operations.
Roche and Halozyme first signed an agreement to apply Halozyme’s Enhanze technology to Roche’s biological therapeutics in 2006. The deal has been expanded on a number of occasions to encompass multiple biological targets. Roche now has an exclusive, worldwide license to develop and commercialize product combinations of its compounds with rHuPH20.
Roche’s new investment in the manufacturing facilities will allow its production line in Kaiseraugst, Switzerland, to supply the device for clinical studies and market launch. Commercial-scale manufacture using a fully-automated process will be carried out at Roche’s facility in Mannheim, Germany.