Halozyme Therapeutics, Inc, announced that the commercial launch of MabThera SC in Europe has triggered a $5 million milestone payment to Halozyme during the second quarter under the licence and collaboration agreement between Halozyme and Roche. Following the launch of Herceptin SC in September 2013, MabThera SC is the second novel subcutaneous formulation of one of Roche's oncology products using Halozyme's patented Enhanze (recombinant human hyaluronidase) technology to be launched in Europe.
The approval of MabThera SC in Europe in March 2014 for the treatment of patients with follicular lymphoma and diffuse large B-cell lymphoma was primarily based on a clinical development programme which showed that SC administration enabled the delivery of MabThera over approximately five minutes versus 2.5 hours intravenously without compromising its proven efficacy and safety. This innovative formulation could potentially save time for patients, physicians and other health care providers in Europe.
There are two main types of lymphoma: Hodgkin lymphoma and non-Hodgkin lymphoma (NHL).
NHL represents approximately 85 per cent of all lymphoma diagnosed and was responsible for approximately 200,000 annual deaths worldwide in 20122.
Lymphomas are a cancer of the lymphatic system (composed of lymph vessels, lymph nodes and organs) which helps to keep the bodily fluid levels balanced and to defend the body against invasion by disease. Lymphoma develops when white blood cells (usually B-lymphocytes) in the lymph fluid become cancerous and begin to multiply and collect in the lymph nodes or lymphatic tissues such as the spleen. Some of these cells are released into the bloodstream and spread around the body, interfering with the body's production of healthy blood cells.
In December 2006, Halozyme entered into an agreement with Roche to apply Halozyme's patented Enhanze technology (recombinant human hyaluronidase or rHuPH20) to Roche's biological therapeutic compounds. To date, Roche has elected to explore the use of rHuPH20 for up to a total of five exclusive targets, and Roche retains the option to apply rHuPH20 to three additional targets through the payment of annual licence maintenance fees. 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 any other product candidates which would be successfully developed and commercialised under the agreement.