Date: 2016-05-09
Type of information: discontinuation of development
phase: 3
Announcement: discontinuation of development
Company: Epirus Biopharmaceuticals (USA - MA)
Product: BOW015 - Infimab® (infliximab - biosimilar version of Remicade®)
Action
mechanism: biosimilar/monoclonal antibody. BOW015 is a biosimilar version of infliximab (reference biologic Remicade®). It is used to treat autoimmune diseases, including rheumatoid arthritis. BOW015 is currently approved in India and has been launched in collaboration with commercialization partner Sun Pharma under the trade name, Infimab™. Epirus is actively progressing applications for marketing approval for BOW015 in targeted accessible markets, including Latin America, where Epirus has signed a distribution deal with mAbxience.
Disease: rheumatoid arthritis
Therapeutic area: Autoimmune diseases – Inflammatory diseases - Rheumatic diseases
Country:
Trial
details: The UNIFORM Study is a prospective, 58-week, randomized, double-blind, parallel group, multicentre global phase 3 clinical study to evaluate the efficacy, safety and immunogenicity of BOW015 (infliximab-EPIRUS) compared to Remicade in subjects with active rheumatoid arthritis despite methotrexate therapy. The primary endpoint at week 16 is the proportion of patients that meet ACR20 (20 percent or greater improvement in American College of Rheumatology assessment).(NCT02683564)
Latest
news: * On May 9, 2016, Epirus Biopharmaceuticals announced reprioritization of the company's pipeline to focus exclusively on developing biosimilars for the treatment of rare diseases. With the prioritization of its rare disease biosimilar assets, Epirus will suspend lead program BOW015 (infliximab, reference biologic Remicade®) and work to further evaluate strategic options for the program, which may include partnerships, divestitures and/or other value-generating alternatives. The Company's decision to suspend its BOW015 program is based on cost-savings, not technical reasons, and the program remains ready to commence its planned global Phase 3 clinical study. * On February 9, 2016, Epirus Biopharmaceuticals announced the initiation of its global registration study for BOW015 (infliximab, reference biologic Remicade®ii) in active rheumatoid arthritis patients. Epirus plans to enroll over 500 patients in the UNIFORM Study, which will be conducted at sites in Europe, North America and Latin America. Epirus is targeting a harmonized global filing for marketing approval for BOW015 in 2017 based on 30-week data.
The UNIFORM Study continues the global clinical development program, building on positive data from Epirus' Phase 1 study in healthy volunteers and Phase 3 study in active RA patients presented at recent American College of Rheumatology (ACR) and European League Against Rheumatism (EULAR) meetings. The data presented reinforced the analytical, pharmacokinetic, safety and efficacy profile for BOW015, further demonstrating biosimilarity between BOW015 and infliximab. To date nearly 1,000 patients have already been treated with BOW015.
