Halozyme Announces Roche Doses First Patient in Phase 3 Clinical Trial With Subcutaneous MabThera® (rituximab)

- Subcutaneous MabThera formulated with Halozyme's recombinant human enzyme -

- Halozyme to receive milestone payment of $5 million -

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Feb 16, 2011, 01:00 ET

SAN DIEGO, Feb. 16, 2011 /PRNewswire/ -- 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).

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"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.

Halozyme-Roche Collaboration

In December 2006, Halozyme 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 commercialize rHuPH20 with an additional three potential targets. Pending the successful achievement of a series of clinical, regulatory, and sales events, Roche will pay Halozyme additional milestones as well as royalties on future product sales. Under the collaboration, Roche has access to Halozyme's expertise in developing and applying rHuPH20 to Roche biologics directed at multiple targets. Roche obtained a worldwide, exclusive license to develop and commercialize product combinations of rHuPH20 and Roche compounds resulting from the collaboration.

About Follicular Lymphoma and Non-Hodgkin's Lymphoma

Non-Hodgkin's lymphoma is diagnosed in approximately 356,000 people worldwide each year according to the WHO. Follicular lymphoma, a cancer of the blood, is a common type of NHL and accounts for about 20% of the new cases of NHL each year. NHL unfortunately remains incurable and patients ultimately relapse and require additional treatments.

About Halozyme

Halozyme Therapeutics is a biopharmaceutical company developing and commercializing products targeting the extracellular matrix for the endocrinology, oncology, dermatology and drug delivery markets. The company's product portfolio is based primarily on intellectual property covering the family of human enzymes known as hyaluronidases and additional enzymes that affect the extracellular matrix. Halozyme's Enhanze™ technology is a novel drug delivery platform designed to increase the absorption and dispersion of biologics. The company has key partnerships with Roche to apply Enhanze technology to Roche's biological therapeutics, including Herceptin® and MabThera®, and with Baxter BioScience to apply Enhanze technology to immunoglobulin. Halozyme's Ultrafast Insulin program combines its rHuPH20 enzyme with mealtime insulins, which may produce more rapid absorption, faster action, and improved glycemic control. The product candidates in Halozyme's pipeline target multiple areas of significant unmet medical need. For more information visit 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, (i) Roche's progress under the collaboration, (ii) the potential achievement of various milestones, and (iii) the advantages of SC MabThera) 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 regulatory approval requirements 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.