Halozyme Announces Roche Marketing Authorization For MabThera SC For Patients With Common Forms Of Non-Hodgkin Lymphoma In European Union
, March 28, 2014
/PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) announced today that the European Commission (EC) has approved Roche's new subcutaneous (SC) formulation of MabThera®
(rituximab) for the treatment of patients with follicular lymphoma and diffuse large B-cell lymphoma. Following the approval of Herceptin SC in September 2013
, this is the second European approval for a novel subcutaneous formulation of one of Roche's oncology products using Halozyme's patented Enhanze
(recombinant human hyaluronidase) technology.
"Today's approval in the EU offers another treatment option for patients with common forms of non-Hodgkin lymphoma and is yet another validating milestone for our proprietary technology," said Dr. Helen Torley, President and Chief Executive Officer. "With an administration time of approximately five minutes compared to the approximately 2.5 hour infusion time for intravenous MabThera, this innovative formulation could potentially save time for patients, physicians and other health care providers in Europe."
The European approval was primarily based on data from the pivotal SABRINA study, which was recently published in the Lancet Oncology[i].
Roche has stated that they expect to begin launching MabThera SC in a number of European markets throughout 2014.
About non-Hodgkin lymphoma
There are two main types of lymphoma: Hodgkin lymphoma and non-Hodgkin lymphoma (NHL). NHL represents approximately 85% of all lymphoma diagnosed[ii] and was responsible for approximately 200,000 annual deaths worldwide in 2012[iii].
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 license 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 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 dispersion and absorption of biologics, drugs and fluids. Halozyme's pipeline addresses therapeutic areas, including oncology, diabetes and dermatology that have significant unmet medical need today. The Company markets Hylenex® recombinant (hyaluronidase human injection) and has partnerships with Roche, Pfizer and Baxter. Halozyme is headquartered in San Diego, CA. For more information on how we are innovating, please visit our corporate website at www.halozyme.comand follow us on Twitter @HALOTherapeutic.
Safe Harbor Statement
This release includes forward-looking statements such as the potential benefits of MabThera SC to patients, physicians and the healthcare system, 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 approval of product candidates under the Halozyme-Roche collaboration by applicable regulatory authorities; satisfaction of regulatory and other requirements; actions of regulatory bodies and other governmental authorities; issues encountered in the sale of MabThera SC and other product candidates under the Halozyme-Roche collaboration including the countries where the product is approved, approval timelines, the rate of conversion of IV formulation users to SC users, pricing and other commercial factors; unexpected adverse events; changes in laws and regulations; competitive conditions; and other risks identified in Halozyme's Annual Report on Form 10-K filed with the Securities and Exchange Commission on February 28, 2014. Halozyme does not undertake to update its forward-looking statements.
[i] Davies, A. et al. (2014) Pharmacokinetics and safety of subcutaneous rituximab in follicular lymphoma (SABRINA): stage 1 analysis of a randomised phase 3 study The Lancet Oncology, Early Online Publication, 10 February 2014
[ii] Globocan (2012) Table by cancers. Worldwide incidence of cancers in males and females.
http://globocan.iarc.fr/ (URL accessed 3.03.14).
[iii] Globocan (2012) Cancer Incidence and Mortality Worldwide. World, non-Hodgkin lymphoma, 2010. (URL accessed 18.09.13). http://globocan.iarc.fr/Pages/fact_sheets_population.aspx
(URL accessed 03.03.14).
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