Halozyme Therapeutics, Inc.,  a biopharmaceutical company, has announced that the European Commission has granted marketing authorization to Roche for the use of a time-saving subcutaneous (SC) formulation of its 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. 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.

Breast cancer is the most common cancer among women worldwide. In 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 per cent to 20 per cent of women with breast cancer. HER2-positive cancer is a particularly aggressive form of breast cancer.

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 III registration trial of subcutaneous (SC) MabThera (rituximab), an anticancer biologic, in patients with non-Hodgkin's lymphoma (NHL) and chronic lymphocytic leukaemia (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.