Halozyme Announces Positive Opinion from CHMP On Roche's Herceptin SC for European Approval

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Jun 28, 2013, 11:34 ET

SAN DIEGO, June 28, 2013 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) announced today that Roche received a positive recommendation from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) for the subcutaneous formulation of Herceptin^® (trastuzumab) using Halozyme's recombinant human hyaluronidase (rHuPH20) for the treatment of patients with HER2-positive breast cancer in Europe.

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Roche's pivotal Phase 3 HannaH study, conducted in 102 sites outside the US, demonstrated that Herceptin SC may help decrease the time patients spend receiving treatment at a hospital or physician's practice, by reducing the administration time. A typical IV infusion of Herceptin can take 30 to 90 minutes, per dose, whereas the same dose delivered subcutaneously can be administered in two to five minutes by an injection under the skin.¹

"Pending European approval, this subcutaneous formulation of Herceptin will provide a new route of administration that could potentially save time for both physicians and HER2-positive breast cancer patients in Europe," said Gregory I. Frost, Ph.D., President and Chief Executive Officer, Halozyme Therapeutics. "We are pleased that our technology has helped enable this new option for patients."

Study results showed that the safety and efficacy of the subcutaneous formulation of Herceptin is comparable to treatment with Herceptin administered intravenously.¹Overall, the safety profile in both arms of the HannaH study was consistent with that expected from standard treatment with Herceptin and chemotherapy in this setting. No new safety signals were identified.

About breast cancer
Breast cancer is the most common cancer among women worldwide.² Each year, about 1.4 million new cases of breast cancer are diagnosed worldwide, and over 450,000 women will die of the disease annually.²In HER2-positive breast cancer, increased quantities of the human epidermal growth factor receptor 2 (HER2) are present on the surface of the tumour cells. This is known as "HER2 positivity" and affects approximately 15-20 percent of women with breast cancer.³ HER2-positive cancer is a particularly aggressive form of breast cancer.⁴

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, which increase the absorption and dispersion of biologics, drugs and fluids. Halozyme's pipeline addresses therapeutic areas, including diabetes, oncology and dermatology that have significant unmet medical need. The Company markets Hylenex^®recombinant (hyaluronidase human injection) and has partnerships with Roche, Pfizer, 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.

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. To date, Roche has elected to develop and commercialize products using rHuPH20 to a total of five exclusive targets, and Roche retains the option to apply rHuPH20 to three additional targets through the payment of annual license maintenance fees. In February 2011, Roche began a Phase 3 registration trial of subcutaneous (SC) MabThera (rituximab), an anticancer biologic, in patients with non-Hodgkin's lymphoma (NHL) and chronic lymphocytic leukemia (CLL). Subject to the successful achievement of clinical, regulatory, and sales events, Roche will pay Halozyme additional milestones as well as royalties on product sales for Herceptin SC, MabThera SC and other product candidates developed and commercialized under the agreement.

Safe Harbor Statement
This release includes forward-looking statements such as the potential benefits of Herceptin SC to patients, physicians and the healthcare system, and the possible receipt by Halozyme of future milestones and royalties under the Roche/Halozyme collaboration agreement. The statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those in the forward-looking statements: the approval of Herceptin SC by the European Union; satisfaction of regulatory and other requirements; actions of regulatory bodies and other governmental authorities; unexpected adverse events; changes in laws and regulations; competitive conditions; and other risks identified in Halozyme's Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on May 8, 2013. Halozyme does not undertake to update its forward-looking statements.

References:

¹Gustavo Ismael, et al. Subcutaneous versus intravenous administration of (neo)adjuvant trastuzumab in patients with HER2-positive, clinical stage I–III breast cancer (HannaH study): a phase 3, open-label, multicentre, randomised trial. Lancet Oncology, published online August 2012.
²Ferlay J, Shin HR, Bray F, Forman D, Mathers C and Parkin DM GLOBOCAN 2008, Cancer Incidence and Mortality Worldwide: IARC Cancer Base No. 10 [Internet]. Lyon, France: International Agency for Research on Cancer; 2010. Available from: http://globocan.iarc.fr.
³Wolff A.C et al. American Society of Clinical Oncology/ College of American Pathologists Guideline Recommendations for Human Epidermal Growth Factor Receptor 2 Testing in Breast Cancer. Arch Pathol Lab Med—Vol 131, January 2007.
⁴Slamon D et al. Adjuvant Trastuzumab in HER2-Positive Breast Cancer. N Engl J Med 2011; 365:1273-83.

Investor Contact:
David Ramsay
Halozyme Therapeutics
858-704-8260
[email protected]

Media Contact:
Nurha Hindi
Hill+Knowlton Strategies
310-633-9434
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SOURCE Halozyme Therapeutics, Inc.