Halozyme Therapeutics, Inc., a biopharmaceutical company dedicated to developing and commercializing innovative products, announced that the commercial launch of Herceptin SC in Europe has triggered a $10 million milestone payment to the company 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."
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.