Roche is investing about 190 Mio Swiss Francs at its production sites in Kaiseraugst, Switzerland, and Mannheim, Germany, to manufacture a patient-friendly device which might for the first time allow patients to self-administer biological cancer medicines. The production line in Kaiseraugst will provide the supply for clinical studies and market launch, and a full scale automated production line in Mannheim will deliver commercial supply to markets.

The new infusion-free device will deliver an innovative Herceptin (trastuzumab) formulation developed with Halozyme Therapeutics’s “Enhanze” technology. This Herceptin formulation together with the ready-to-use administration device allows for injection of larger volumes of medicines into the tissue under the skin. Medicines which are currently administered by infusion in a hospital could therefore be self-administered via a subcutaneous injection.

Today, breast cancer patients treated with Herceptin generally receive the drug as an infusion in a hospital; the infusion time is around 60 minutes. In contrast, subcutaneous Herceptin administration takes only about five minutes and means that patients with early HER2-positive breast cancer completing their one year of Herceptin therapy would have greater convenience of being able to receive treatment at their family doctor’s office or at home. It could also help to maximize the efficient use of hospital resources and reduce costs. Pat Yang, Head of Roche Pharma Global Technical Operations said: “We always strive to improve our products and manufacturing technologies, which in turn benefit our patients. This innovative formulation and the associated new device are designed to simplify patients’ lives. There is also hope that patients will experience fewer infusion reactions due to the slower absorption after subcutaneous administration."

A phase III trial investigating subcutaneous Herceptin is underway.

In December 2006, Halozyme entered into an agreement with Roche to apply Halozyme's proprietary Enhanze technology to Roche's biological therapeutic compounds. Roche has access to Halozyme's expertise in developing and applying Halozyme’s recombinant human enzyme, rHuPH20, to Roche biologics directed at multiple targets. Roche obtained a worldwide, exclusive license to develop and commercialize product combinations of rHuPH20 and Roche compounds resulting from the collaboration.