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Halozyme Announced Roche Filed A Marketing Authorization Application For Subcutaneous MabThera

SAN DIEGO, Dec. 8, 2012 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) today announced that Roche has submitted a line extension application to the European Medicines Agency for a subcutaneous (SC) formulation of MabThera ® (rituxumab). The filing of the application triggered a $4 million milestone payment to Halozyme under the License and Collaboration Agreement between Halozyme and Roche.


"This regulatory filing brings patients and physicians one step closer to an enhanced treatment option for Non-Hodgkin Lymphoma," said Gregory I. Frost, Ph.D., Halozyme's President and Chief Executive Officer. "Offering a subcutaneous formulation of MabThera could provide patients with a therapy which is less invasive, shortens administration times and potentially reduces healthcare costs."

Roche reported positive data today from two clinical studies of MabThera given by subcutaneous injection at the 54 th annual meeting of the American Society of Hematology (ASH). The pivotal study data presented showed that SC administration of MabThera enabled the delivery of MabThera over approximately five minutes without compromising its proven efficacy and safety. Both studies showed that a fixed dose of MabThera can be administered subcutaneously, potentially allowing patients to spend less time in infusion centers receiving their MabThera treatment. Specifically, the studies showed that SC injection resulted in non-inferior MabThera concentrations in the blood (pharmacokinetics; PK) compared with standard intravenous (IV) infusion. Overall, SC and IV adverse event profiles were similar and administration related reactions were mostly of mild to moderate intensity. (For more detailed information on the studies, see Roche's media release issued earlier today.)

Currently, MabThera is available as an IV formulation. MabThera SC uses Halozyme's Enhanzeâ„¢ Technology which enables the injection of large volumes of a medication under the skin. In a clinical study, patients were able to receive MabThera over approximately 5 minutes via SC injection versus a few hours with IV-infused MabThera.

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