BOSTON--(BUSINESS WIRE)--EPIRUS Biopharmaceuticals, Inc. (“EPIRUS”), formerly known as fourteen22 Inc, announced that its lead asset, BOW-015, achieved bioequivalence to Remicade® in a single dose comparator trial.
“The data from this Phase 1 study are encouraging and support the bioequivalence of BOW-015 with Remicade. Biosimilars, when developed with the proper rigor, will offer patients around the world similarly effective biological therapies that should be less costly than those currently available. I look forward to seeing data from the ongoing Phase 3 trial”
In February 2012, the United Kingdom’s MHRA (Medicines and Healthcare Regulatory Agency) approved a 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.
“The data from this Phase 1 study are encouraging and support the bioequivalence of BOW-015 with Remicade. Biosimilars, when developed with the proper rigor, will offer patients around the world similarly effective biological therapies that should be less costly than those currently available. I look forward to seeing data from the ongoing Phase 3 trial,” commented Jonathan Kay, MD, Professor of Medicine, University of Massachusetts Medical School, and Director of Clinical Research, Division of Rheumatology, UMass Memorial Medical Center, Worcester, Massachusetts.
EPIRUS is currently conducting a registrational Phase 3 program for BOW-015 with initial data expected in late 2013.
EPIRUS was financed in early 2011 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 are excited to continue working with our In Market partners globally to continue building out our product pipeline and regional manufacturing model.”
About EPIRUS Biopharmaceuticals
EPIRUS is focusing on the central development of a broad pipeline of biosimilar monoclonal antibodies and therapeutic proteins, optimized 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 designed to provide 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 aims to enable localized manufacturing in emerging economies where EPIRUS is developing partnerships combining public and private sector financial support and expertise. EPIRUS is focusing 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 www.5amventures.com.
About Montreux Equity Partners
Montreux Equity Partners (MEP) is a private investment firm dedicated to building the leading healthcare companies of tomorrow. Located in Silicon Valley and San Francisco, MEP currently invests out of its fourth fund, a $250 million vehicle. MEP focuses on companies that pursue compelling commercial growth opportunities. MEP's portfolio has a significant global presence, including operations in the U.S., Europe, Latin America, and Asia. For more information visit www.mepvc.com.
About TPG Biotech
TPG Biotech is part of the growth equity and venture investment platform of TPG, the global private investment firm. With more than $1.2 billion under management, TPG Biotech targets investments in pharmaceutical discovery and development, medical technology, diagnostics, healthcare and pharmaceutical services, life sciences, as well as industrial applications of biotechnology. For more information visit www.tpgbiotech.com.