Teva Pharmaceutical Industries has formed an exclusive partnership with Celltrion, an Incheon, Korea-based life sciences company, and Celltrion Healthcare to commercialize two of Celltrion’s monoclonal antibody (mAb) biosimilar candidates in the US and Canada. Under 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.

One mAb biosimilar candidate is CT-P10, referencing Roche’ Rituxan (rituximab) for non-Hodgkin’s lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis, Wegener’s granulomatosis, and microscopic polyangiitis. The other candidate is CT-P6, referencing Roche’s Herceptin (trastuzumab) for treating HER2-overexpressing breast cancer and HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma. Rituxan and Herceptin are two of Roche’s leading products, with 2015 sales of CHF 5.6 billion ($5.7 billion) and CHF 6.5 billion ($6.7 billion), respectively.

Both CT-P10 and CT-P6 are currently in late-stage Phase III development and their primary endpoints have been met. Celltrion submitted CT-P10 to the European Medicines Agency (EMA) for review in October 2015 and is preparing CT-P6 for submission to the EMA this quarter. As part of the agreement, Teva will be responsible for all commercial activities in the US and Canada, pending regulatory approvals for both products. Celltrion has responsibility for completing all clinical development and regulatory activities.

Source: Teva Pharmaceutical Industries