Commercial Launch of Herceptin SC in EU Triggers Milestone Payment to Halozyme from Roche
SAN DIEGO, Sept. 26, 2013 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) today announced that the commercial launch of Herceptin® SC in Europe has triggered a $10 million milestone payment to Halozyme under the License and Collaboration Agreement between Halozyme and Roche. This time-saving subcutaneous formulation of Herceptin (trastuzumab) using Halozyme's recombinant human hyaluronidase (rHuPH20) received marketing authorization from the European Commission on August 28, 2013 for the treatment of patients with HER2-positive breast cancer and was launched upon approval. Herceptin SC reduces treatment times and enhances convenience compared to the standard intravenous (IV) form.
"With pricing on par with the intravenous formulation, Herceptin SC represents a compelling treatment alternative for breast cancer patients in Europe, and we congratulate Roche on making this time-saving therapy available to patients in Europe so quickly," said Gregory I. Frost, Ph.D., President and Chief Executive Officer of Halozyme. "This will be the third commercial product using our rHuPH20 enzyme and represents a significant achievement for our technology and company as a whole."
About Breast Cancer
Breast cancer is the most common cancer among women worldwide.1 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.1 In HER2-positive breast cancer, increased quantities of the human epidermal growth factor receptor 2 (HER2) are present on the surface of the tumor cells. This is known as "HER2 positivity" and affects approximately 15% to 20% of women with breast cancer.2 HER2-positive cancer is a particularly aggressive form of breast cancer.3
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 with 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) and submitted a line extension application to the European Medicines Agency for MabThera SC in December 2012. 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.
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, 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
This release includes forward-looking statements such as the potential benefits of Herceptin SC to patients, and the possible receipt by Halozyme of future milestones and royalties under the Halozyme-Roche 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 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 August 7, 2013. Halozyme does not undertake to update its forward-looking statements.
1Ferlay 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.
2Wolff 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.
3Slamon D et al. Adjuvant Trastuzumab in HER2-Positive Breast Cancer. N Engl J Med 2011; 365:1273-83.
SOURCE Halozyme Therapeutics, Inc.
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