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Halozyme Therapeutics, Inc. (HALO) Announced Roche (RHHBY) Filed a Marketing Authorization Application For Subcutaneous MabThera


12/10/2012 9:16:16 AM

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.

(Logo: http://photos.prnewswire.com/prnh/20100302/LA63139LOGO)

"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 54th 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 Enhanze 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.

About Halozyme

Halozyme Therapeutics is a biopharmaceutical company dedicated to developing and commercializing innovative products that advance patient care. With a diversified portfolio of enzymes that target the extracellular matrix, the Company's research focuses primarily on a family of human enzymes, known as hyaluronidases, that increase the absorption and dispersion of biologics. Halozyme's pipeline addresses therapeutic areas, such as diabetes, oncology and dermatology that have significant unmet medical need. The Company markets HYLENEX® recombinant (hyaluronidase human injection) and has partnerships with Roche, Baxter, ViroPharma and Intrexon. Halozyme is headquartered in San Diego, CA. For more information on how we are innovating, please visit our corporate website at www.halozyme.com.

Safe Harbor Statement

In addition to historical information, the statements set forth above include forward-looking statements (including, without limitation, statements concerning the potential regulatory approval and commercial availability of MabThera SC and the potential benefits and attributes of MabThera SC) that involve risk and uncertainties that could cause actual results to differ materially from those in the forward-looking statements. The forward-looking statements are also identified through use of the words "believe," "enable," "may," "will," "could," "intends," "estimate," "anticipate," "plan," "predict," "probable," "potential," "possible," "should," "continue," and other words of similar meaning. Actual results could differ materially from the expectations contained in forward-looking statements as a result of several factors, including unexpected clinical trial results, delays in development and regulatory review, regulatory approval requirements, unexpected adverse event and competitive conditions. These and other factors that may result in differences are discussed in greater detail in the company's reports on Forms 10-K, 10-Q, and other filings with the Securities and Exchange Commission.

Media/Investor Contact:
Anne Erickson
Executive Director
Halozyme Therapeutics
+1-858-704-826
aerickson@halozyme.com

SOURCE Halozyme Therapeutics, Inc.



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