Halozyme Announces Roche Receives Marketing Authorization for Herceptin SC in European Union
, Sept. 2, 2013
/PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) announced today that the European Commission has granted Roche European Union (EU) marketing authorization for the use of a time-saving subcutaneous (SC) formulation of Herceptin®
(trastuzumab) for the treatment of HER2-positive breast cancer. This formulation utilizes Halozyme's recombinant human hyaluronidase (rHuPH20) and is administered in two to five minutes, rather than 30 to 90 minutes with the standard intravenous form.
"This approval is great news for the more than 80,000 patients who receive treatment with Herceptin each year in the EU," stated Gregory I. Frost, Ph.D., President and Chief Executive Officer of Halozyme. "The reduced administration time and enhanced convenience may enable patients in the EU to spend less time in the hospital while also increasing efficiency for physicians and other health care providers. We're excited that patients will soon benefit from this application of Halozyme's technology."
The European Commission's approval was based on data from the HannaH study which showed that the subcutaneous formulation of Herceptin was associated with comparable efficacy (pathological complete response, pCR) to Herceptin administered intravenously in women with HER2-positive early breast cancer and resulted in non-inferior trastuzumab plasma levels.1 Overall, 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.2 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.3 HER2-positive cancer is a particularly aggressive form of breast cancer.4
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, 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
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 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.
1Gustavo Ismael, et al. Subcutaneous versus intravenous administration of (neo)adjuvant trastuzumab in patients with HER2-positive, clinical stage IIII breast cancer (HannaH study): a phase 3, open-label, multicentre, randomised trial. Lancet Oncology, 2012 Sep;13(9):869-78.
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.
3 Wolff 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 MedVol 131, January 2007.
4Slamon D et al. Adjuvant Trastuzumab in HER2-Positive Breast Cancer. N Engl J Med 2011; 365:1273-83.
SOURCE Halozyme Therapeutics, Inc.