EPIRUS Biopharmaceuticals, Inc. (EPIRUS), formerly fourteen22 Inc, announced that its lead asset, BOW-015, achieved bioequivalence to Remicade® in a single dose comparator trial.
In February 2012, the United Kingdoms MHRA (Medicines and Healthcare Regulatory Agency) approved the single center, double blind, randomized parallel group trial in 84 healthy male volunteers each of whom received a 5 mg/kg single infusion of BOW-015 or Remicade®.
At the conclusion of the trial, BOW-015 met both the primary objectives of bioequivalence in Cmax, AUC(0-t) and AUC(0-∞), as well as the secondary objectives of safety, tolerability and immunogenicity.
I am very encouraged by the data from this study and continue to believe that biosimilars, when developed with the proper rigor, represent a major step forward in patient care globally. I look forward to the initial data from the ongoing Phase 3 trial commented, Jonathon Kay, MD, Professor of Medicine, University of Massachusetts Medical School, and Director of Clinical Research, Division of Rheumatology, University of Massachusetts Memorial Medical Center, Worcester, Massachusetts.
EPIRUS is currently conducting a registrational Phase 3 program for BOW-015 with initial data expected late 2013.
EPIRUS was financed in late 2010 by 5AM Ventures. Montreux Equity Partners and TPG Biotech. Following a restructuring in 2012 EPIRUS has expanded its focus to centrally develop a broad pipeline of biosimilar monoclonal antibodies, optimised for use within its SCALE disposable manufacturing system, and designed to be deployed in an In Market, For Market manufacturing configuration. This innovative platform is designed to enable localized manufacturing in key emerging economies where EPIRUS is developing partnerships combining public and private sector financial support and expertise.
EPIRUS President and Chief Executive Officer, Amit Munshi commented, We are pleased with this initial data and look forward to working with our partners globally to continue building out our product pipeline and regional manufacturing model.
About EPIRUS Biopharmaceuticals
EPIRUS is focused on the central development of a broad pipeline of biosimilar monoclonal antibodies and therapeutic proteins, optimised for use within the SCALE disposable manufacturing system, and designed to be deployed in an In Market, For Market manufacturing configuration. SCALE is a modular state-of-the-art manufacturing process utilizing the latest in disposable technology. It is ideally suited for use as a localized In Market for Market manufacturing solution providing speed to market, low capital cost, campaign flexibility and utilization rates which can be tailored to local and or regional needs.
This innovative product platform is designed to enable localized manufacturing in key emerging economies where EPIRUS is developing partnerships combining public and private sector financial support and expertise. EPIRUS is currently focused on a range of emerging markets, including, Brazil, Turkey, Russia, MENA, and the ASEAN markets.
EPIRUS envisions the creation of unprecedented patient access to biosimilar therapeutics through efficient global development and local production of these important medicines.
About 5AM Ventures
5AM Ventures is an early-stage venture capital firm focused on building next-generation life science companies. Founded in 2002, 5AM Ventures has over $435 million under management and is actively investing 5AM Ventures III, L.P., a $220 million fund. The firm has offices in Menlo Park, CA and Waltham, MA. 5AM is directly involved in company strategy, management recruiting, business development and fundraising and often takes on short-term operating roles. For more information visit Inquiry@Epirusbiopharma.com