Sandoz strengthens its biosimilars portfolio with acquisition of Pfizer's biosimilar infliximab in EEA

Novartis International AG / Sandoz strengthens its biosimilars portfolio with acquisition of Pfizer's biosimilar infliximab in EEA . Processed and transmitted by NASDAQ OMX Corporate Solutions. The issuer is solely responsible for the content of this announcement.

• Sandoz acquires rights to PF-06438179 (biosimilar infliximab) in the European Economic Area (EEA)*

Sandoz plans to complete Phase III development program and file for registration in the EU

Deal strengthens Novartis immunology portfolio which includes investigational biosimilars adalimumab, etanercept and rituximab

Holzkirchen, February 12, 2016 - Sandoz, a Novartis company and a global leader in biosimilars, announced today that it has acquired from Pfizer the rights for the development and commercialization of PF-06438179 (biosimilar infliximab) in the 28 countries that form the European Economic Area (EEA)*. Infliximab is a tumor necrosis factor alpha (TNF-alpha) inhibitor used to treat a range of autoimmune diseases including rheumatoid arthritis (RA) and psoriasis.

"Infliximab is one of the most important biologic therapy options for people living with severe autoimmune diseases such as rheumatoid arthritis" said Richard Francis, Global Head of Sandoz. "We intend to complete the development and registration of PF-06438179 and make it available to patients across Europe as part of our robust portfolio of immunology treatments" Francis continued. 

Under the terms of the deal, Sandoz plans to complete the clinical study program and submit the biosimilar infliximab to the European Medicines Agency (EMA) for regulatory approval and registration with the European Commission. Included in the program is a global phase III trial - REFLECTIONS (B537-02) investigating the safety and efficacy of PF-06438179 and infliximab in combination with methotrexate in subjects with active rheumatoid arthritis who have had an inadequate response to methotrexate. Sandoz acquired the rights to infliximab, following Pfizer's commitments to the European Commission in connection with the acquisition of Hospira, Inc. to divest the program.