Halozyme, Roche Initiate Phase 3 Trial For Herceptin

Halozyme Therapeutics (Halozyme) and Roche have reported dosing of the first patient in a phase 3 registration trial using Enhanze technology (rHuPH20, recombinant human hyaluronidase) in a subcutaneous formulation with Roche’s anticancer biologic, Herceptin (trastuzumab).

The company said that the initiation of the clinical trial has triggered a milestone payment of $5m to Halozyme. Herceptin is approved to treat HER2-positive breast cancer and currently is given intravenously (IV).

Reportedly, in December 2006, Halozyme has entered into an agreement with Roche to apply Halozyme’s proprietary Enhanze technology to Roche’s biological therapeutic compounds. Under the terms of the agreement, Roche made an initial payment to Halozyme for the application of its recombinant human enzyme, rHuPH20, to three pre-defined biologic targets exclusive to Roche.

In December 2008, Roche selected a fourth biologic target followed by selection of a fifth target in June 2009 and has the option to exclusively develop and commercialise rHuPH20 with an additional eight potential targets.

Jonathan Lim, president and CEO at Halozyme, said: “The start of this phase 3 subcutaneous Herceptin trial is a major achievement for the Halozyme and Roche collaboration, representing the first Roche target to reach a pivotal trial. I congratulate the alliance on the speed of progress to phase 3.”