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Halozyme Therapeutics recommended for European Commission approval

San Diego-based Halozyme Therapeutics Inc. (Nasdaq: HALO) announced Friday the EU Committee for Medicinal Products for Human Use has recommended that the European Commission approved its treatment of common forms of non-Hodgkin lymphoma.

The treatment is Roche's subcutaneous formulation of MabThera (rituximab) using Halozyme's recombinant human hyaluronidase (rHuPH20).

“This subcutaneous formulation of MabThera, pending approval in the EU, provides a new route of administration and a shortened treatment time of approximately five minutes that could potentially save time for NHL patients, physicians and other health care providers in Europe,” said Dr. Helen Torley, president and CEO of Halozyme Therapeutics. “We are excited that our technology has helped enable this potential new treatment option for patients in Europe”

MabThera is currently delivered by an intravenous infusion, which takes approximately 2.5 hours. The new MabThera SC formulation comes as a ready-to-use, fixed dose, 1,400 mg solution, which shortens pharmacy preparation time and reduces the overall impact on hospital resources.

The EU Committee opinion is based primarily on data from Roche's Phase 3 SABRINA study. Roche expects a final decision from the European Commission in the coming months.

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