Home Contact Us ABOUT HALOZYME NEWSROOM TECHNOLOGY PRODUCTS & PIPELINE INVESTORS CAREERS INVESTIGATORS Products & Pipeline Products Pipeline PEGPH20 Roche Products Pfizer Products Baxalta-HYQVIA Roche Products In December 2006, Halozyme granted Roche an exclusive license to develop and commercialize product combinations of rHuPH20 with Roche target compounds. Currently, Roche may apply rHuPH20 to up to eight biologic targets. The principal focus of the Roche partnership is to commercialize biologics, which can be administered subcutaneously through the use of the rHuPH20 enzyme, instead of intravenously (IV). Potential benefits of subcutaneous administration for biologics include patient convenience, reduction of infusion reactions, shorter administration time, lower administration costs and life cycle management. Upon the successful completion of various clinical, regulatory and sales events, Roche is obligated to make milestone payments to Halozyme, in addition to royalty payments on the sales of products that result from the partnership. Biologics directed at three Roche exclusive targets have commenced clinical trials. Subcutaneous Herceptin® and subcutaneous MABTHERA® are currently in Phase 3 clinical trials, while subcutaneous Actemra® has completed a Phase 1 clinical trial. Positive results from a Phase 3 clinical trial for a fixed dose subcutaneous Herceptin product in women with early HER2-positive breast cancer have been reported. The primary endpoints were a comparison of standard intravenous Herceptin to subcutaneous Herceptin for pathologic complete response rate and trough plasma concentration of Herceptin. In March 2012, Roche submitted a Line Extension Application to the European Medicines Agency (EMA) for a subcutaneous formulation of Herceptin to treat patients with HER2-positive breast cancer. On June 28, 2013, Roche and Halozyme announced that the EMA's Committee for Medicinal Products for Human Use (EMA CHMP) granted a positive opinion to Roche for the use of Herceptin SC for HER2-positive breast cancer patients in Europe. A clinical study is also underway for a single-use administration device that contains rHuPH20 and Herceptin formulated in the same cartridge. The pre-loaded, autoinjector device that Roche has developed is about the size of a cellular phone, and is designed to administer the subcutaneous Herceptin therapy in less than five minutes. This may allow patients to receive their Herceptin treatment outside of an infusion center from their family doctor or via self-administration. A Phase 3 trial for subcutaneous MABTHERA with rHuPH20 began in February 2011 in patients with follicular non-Hodgkin’s lymphoma. Patients were randomized to receive either subcutaneous or intravenous MABTHERA along with standard chemotherapy. The first dose of MABTHERA was administered IV in both arms so that trough concentration could be compared for those patients randomized to subcutaneous administration. The primary endpoints were a comparison of subcutaneous MABTHERA trough plasma concentration to IV at day 21 and the overall response rate in each treatment arm at the end of induction treatment at week 24 (cycle 8). In December 2012, Roche submitted a Line Extension Application to the EMA for a subcutaneous formulation of MABTHERA to treat patients with follicular non-Hodgkin's lymphoma. In March 2014, Roche and Halozyme announced that the European Commission approved the subcutaneous formulation of MABTHERA for the treatement of patients with follicular lymphoma and diffuse large B-cell lymphoma. MAKING TREATMENTS EASIER Roche is developing product combinations utilizing rHuPH20 to facilitate the subcutaneous delivery of treatments that are currently administered intravenously such as Herceptin and Mabthera. Website Design: Hane Chow Inc. © 2011, 2012 Halozyme, Inc. All rights reserved. All trademarks belong to their respective owners. Powered By Q4 Web Systems 4.1.1.49