Celltrion Healthcare And Teva Enters Into Exclusive Business Collaboration Agreement For Truxima And Herzuma In The U.S. And Canada

• Celltrion Healthcare partners with Teva, a leading global pharmaceutical company… North American market is in the range of seven trillion won
• Celltrion Healthcare to receive an upfront payment of 160 million dollars in license fees … profits from commercialization to be shared between two companies

Celltrion’s commercial partner for its second and third biosimilars for the North America market has been determined. Celltrion Healthcare, which is in charge of Celltrion’s overseas marketing, recently announced that it has selected Teva Pharmaceuticals, a global pharmaceutical company based in Israel, as its exclusive commercial partner for Truxima (project name: CT-P10) and Herzuma (project name: CT-P6) in the US and Canada. 

Truxima is an antibody biosimilar which is used in the treatment of a number of ailments including rheumatoid arthritis and non-Hodgkin’s Lymphoma, a type of leukemia. Celltrion has applied for marketing authorization from the EMA last October. Mabthera (also known as Rituxan), the reference product to Truxima, was developed by Biogen and marketed by Roche.  This product is one of the 10 best selling drugs in the world, with a revenue of more than 6 trillion won last year. 

Herzuma is a biosimilar to Herceptin, a breast cancer treatment antibody biologic drug developed by Genentech and marketed by Roche. This product is also a blockbuster drug which has sold around seven trillion won last year. Celltrion obtained the marketing authorization for Herzuma in Korea in January 2014, and additional clinical trials on early breast cancer patients has recently completed. Celltrion plans to submit its EMA application for marketing authorization in fourth quarter this year. 

The total revenues from these two drugs in the US and Canada amounts to approximately seven trillion won, which is half of the global sales. Assuming that Truxima and Herzuma take just 20% of that market, an annual revenue of 1.4 trillion won may be expected. It is estimated that Celltrion’s Remsima, a product which preceded Truxima and Herzuma, took 40% of the European market in just one year. 

On the other hand, Teva, the company which Celltrion has partnered with to market Truxima and Herzuma, is a leading global pharmaceutical company that delivers high-quality, patient-centric healthcare solutions used by millions of patients every day. Teva is the world’s largest generic medicines producer, with a portfolio of more than 1,800 molecules and has a world-leading position in innovative treatments for disorders of the central nervous system, including pain, as well as a strong portfolio of respiratory products. After having the license for Truxima and Herzuma returned to it following the merger between Hospira and Pfizer last September, Celltrion Healthcare has been undertaking negotiations with several global pharmaceutical companies who expressed interest in the two products, and in the end, signed the Business Collaboration Agreement with Teva. According to the Agreement, Teva is to pay Celltrion Healthcare an advance payment of 160 million dollars License Fee (approximately 176.7 billion Korean won), with the profits from the commercialization of the two products to be shared with Celltrion Healthcare. The 60 million dollars of the 160 million dollars, however, is refundable or creditable under certain circumstances.

“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. “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.” 

“With the success of Remsima, our first product, achieving a 40% market share in Europe, many global pharmaceutical companies have indicated interest in the license for Truxima and Herzuma in the US and Canada markets.” said a Celltrion Healthcare spokesperson. “After deliberation, we decided to go with Teva, which has proven track record in the global pharmaceutical market with marketing and distribution capabilities, as its commercial partner for Truxima and Herzuma.” 

The Celltrion Healthcare spokesperson added, “Celltrion and Celltrion Healthcare has built a solid business relationship with Teva over the years and, with our strong partnership with Teva, we will do our best to secure strong market competitiveness in the North American mAb biosimilar market.