Date: 2016-10-06
Type of information: Commercialisation agreement
Compound: CT-P10 (biosimilar rituximab - biosimilar version of Mabthera®/Rituxan® ) CT-P6 (biosimilar trastuzumab - biosimilar version of trastuzumab - Herceptin®
Company: Teva Pharmaceutical Industries (Israel) Celltrion Healthcare (South Korea)
Therapeutic area: Cancer - Oncology - Rare diseases - Autoimmune diseases - Rheumatic diseases
Type agreement: commercialisation
Action mechanism: biosimilar product/monoclonal antibody. Rituximab is a chimeric monoclonal antibody against the protein CD20, which is primarily found on the surface of immune system B cells. It was developed by IDEC Pharmaceuticals (now Biogen) and Roche is in charge of global sales. Ritusimab patents already expired in Europe in December 2013 and will expire in the U.S. in September 2016. Trastuzumab is a recombinant DNA-derived humanized monoclonal immunoglobulin G1 kappa antibody approved in many regions for the treatment of HER2-overexpressing early breast cancer, metastatic breast cancer and metastatic gastric cancer.
Disease: non-Hodgkin's lymphoma, chronic lymphocytic leukemia lheumatoid Arthritis (RA), Wegener's Granulomatosis and Microscopic Polyangiitis (MPA)
Details: * On October 6, 2016, Teva Pharmaceutical Industries, Celltrion, Inc. and Celltrion Healthcare announced that the companies have entered into an exclusive partnership to commercialize two of Celltrion's mAb biosimilar candidates in the U.S. and Canada . CT-P10 is a proposed mAb biosimilar to Rituxan® (rituximab), which is used to treat patients with Non-Hodgkin's Lymphoma ( NHL ), Chronic Lymphocytic Leukemia (CLL), Rheumatoid Arthritis (RA), Wegener's Granulomatosis and Microscopic Polyangiitis (MPA). CT-P6 is a proposed mAb biosimilar to Herceptin® (trastuzumab), which is used for the treatment of HER2-overexpressing breast cancer and for the treatment of HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma. Combined annual net sales for Rituxan and Herceptin are approximately $6.5 billion in the U.S. and Canada .
"This commercial partnership with Celltrion enables Teva to expand into the upcoming wave of biosimilars and build on its strong position in the biosimilar space," said Siggi Olafsson , President & CEO of Global Generic Medicines, Teva Pharmaceuticals . "The introduction of two additional mAb biosimilar candidates into our near-term pipeline bolsters our biosimilar portfolio and continues to leverage Teva's unique cross-functional capabilities across both specialty and generic medicines. We look forward to our partnership with Celltrion with its expertise in mAb biosimilar development and manufacturing."
Both CT-P10 and CT-P6 are currently in late-stage Phase III development and their primary endpoints have been successfully achieved. CT-P10 was submitted by Celltrion to the European Medicines Agency (EMA) for review in October 2015 . In the meantime, Celltrion is preparing CT-P6 for submission in Europe seeking approval from the EMA this quarter. As part of the agreement, Teva will be responsible for all commercial activities in the U.S. and Canada , pending regulatory approvals for both products. Celltrion has responsibility for completing all clinical development and regulatory activities.
"With Teva's strong legacy and U.S. commercial presence in Oncology, we are pleased to partner with Celltrion to bring additional biosimilar treatment options to patients," said Rob Koremans, M.D., President and Chief Executive Officer, Global Specialty Medicines, Teva Pharmaceuticals . "By bringing two near-term treatment options into our product offering, we will continue our commitment to serving those dealing with cancer and other serious diseases."
"As a global biopharmaceutical leader with established products as well as a robust biosimilar pipeline and novel drugs, we are very excited about our new partnership with Teva," said HyoungKi Kim, Chief Executive Officer, Celltrion, Inc. "Following on the heels of our global success with RemsimaTM (InflectraTM), our infliximab biosimilar, which has brought affordable and effective biologic treatment to many patients around the world with proven record of quality, efficacy and safety to the reference product, we are confident that we will be able to repeat the same success in the U.S and Canada with CT-P10 and CT-P6 through our partnership with Teva."
Under the terms of the agreement, Teva will pay Celltrion Healthcare $160 million upfront of which up to $60 million is refundable or creditable under certain circumstances. Teva and Celltrion Healthcare will share profit from the commercialization of the mAb biosimilars.
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