Sandoz, a Novartis company focused on generic pharmaceuticals, announced it has acquired the rights to Pfizer’s biosimilar to infliximab (PF-06438179) in the European Economic Area (EEA) as a possible treatment for autoimmune diseases including rheumatoid arthritis (RA) and psoriasis. The financial terms of the acquisition were not released.
According to a press release, the agreement give Sandoz responsibility over the development of the infliximab biosimilar, and its possible commercialization, across all 28 EEA countries upon successful completion of a Phase 3 trial investigating the efficacy and safety of PF-06438179 and infliximab in combination with methotrexate in people with active rheumatoid arthritis. The company will also submit the drug and testing results to the European Medicines Agency for regulatory approval.
“Infliximab is one of the most important biologic therapy options for people living with severe autoimmune diseases such as rheumatoid arthritis,” said Richard Francis, Sandoz’s divison head and CEO. “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.”
The (REFLECTIONS B537-02) clinical trial is a randomized, double-blind two-arm of 614 RA patients with active disease and an inadequate response to methotrexate alone. The trial started in August 2014 and has an estimated primary completion date of June 2016. Its primary outcome measure is the number of participants with an ACR20 (American College of Rheumatology 20%) response at 14 weeks, or at least a 20 percent improvement in measures that include tender joint count, swollen joint count, pain, and disease activity.
Infliximab (Remicade) is a tumor necrosis factor alpha (TNF-α) inhibitor approved to treat a number of autoimmune diseases, including RA, ankylosing spondylitis, psoriatic arthritis, psoriasis, Crohn’s disease and ulcerative colitis (UC).
Pfizer had reached an agreement with the European Commission to divest the biosimilar in connection with its acquisition of Hospira, Inc., Novartis said in a company release.