Halozyme-Roche announce initiation of Phase 3 subcutaneous MabThera trial in follicular NHL

Halozyme Therapeutics, Inc. (Nasdaq: HALO) and Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced the first patient received subcutaneous (SC) MabThera (rituximab), an anticancer biologic, in a Phase 3 registration trial using Enhanze™ technology (rHuPH20, recombinant human hyaluronidase). This represents the second Roche cancer medicine, in addition to Herceptin® SC (trastuzumab), to enter a Phase 3 registration study as part of the Halozyme-Roche collaboration. Initiation of the clinical trial has triggered a milestone payment of $5 million to Halozyme. MabThera is approved to treat non-Hodgkin's lymphoma (NHL) and chronic lymphocytic leukemia (CLL) using different induction and maintenance treatments that are currently given intravenously (IV).

"The start of this Phase 3 subcutaneous MabThera trial in patients with follicular NHL signifies another major achievement for the Halozyme-Roche partnership, and represents the second Roche target to begin a pivotal trial. I congratulate the team on this important accomplishment," said Gregory Frost, Ph.D., Halozyme's president and CEO. "MabThera is the standard of care for several serious forms of blood cancer and we expect this subcutaneous alternative could provide a compelling administration option."

This innovative technology may allow patients with NHL to receive MabThera in less than 10 minutes via a simple SC injection at their physician's office. Administration of SC MabThera means that patients with NHL undergoing induction therapy or completing two years of maintenance treatment with MabThera would have the greater convenience of being able to receive a much shorter drug administration, a compelling and welcome benefit.

Offering SC MabThera treatment outside of the IV infusion center or hospital setting could also reduce costs and potentially help to maximize the efficient use of hospital resources. Additional information about this Phase 3 SC MabThera clinical trial can be found at clinicaltrials.gov and roche-trials.com.