BOSTON, June 10, 2015 (GLOBE NEWSWIRE) -- EPIRUS Biopharmaceuticals, Inc. (Nasdaq:EPRS), a Boston-based biopharmaceutical company focused on the global development and commercialization of biosimilar monoclonal antibodies, today announced the presentation of new BOW015 (infliximab, reference biologic Remicade®) data at the European League Against Rheumatism Annual Congress (EULAR 2015) in Rome, Italy on June 10 – 13, 2015.
BOW015 has been extensively characterized and the posters presented during EULAR 2015 share new data from EPIRUS’ Phase I study in healthy volunteers and its Phase III trial in active rheumatoid arthritis (RA) patients. The data reinforces the analytical, pharmacokinetic, safety and efficacy profile for BOW015, further demonstrating the biosimilarity between BOW015 and infliximab.
“EPIRUS has been building a robust data package for BOW015. The results of their clinical studies that are being presented at EULAR further validate the safety and efficacy of BOW015 as a potential treatment for patients with RA and other inflammatory diseases,” said Jonathan Kay, M.D., lead author, professor of medicine and director of clinical research in the division of rheumatology at the University of Massachusetts Medical School and UMass Memorial Medical Center in Worcester, Massachusetts.
“We are pleased to present new data at this distinguished congress providing additional analyses on disease activity and disability outcomes, and further detail surrounding the safety profile for BOW015,” stated Cheryl Lassen, M.D., vice president, clinical development at EPIRUS Biopharmaceuticals.
EPIRUS Posters / Abstracts:
- Poster #FRI0116 – Pharmacokinetic Results from a Phase 1, Single-Centre Double-Blind, Randomised, Single-Dose, Parallel Group Study Comparing 5 MG/KG IV Infusion of BOW015 and Reference Infliximab in Healthy Male Volunteers
- Poster #FRI0117 – BOW015, a Biosimilar Infliximab: Disease Activity and Disability Outcomes from a Phase 3 Active Comparator Study in Patients with Active Rheumatoid Arthritis on Stable Methotrexate Doses
- Poster #SAT0151 – Safety Profile of BOW015, a Biosimilar Infliximab in Healthy Subjects and Patients with Active Rheumatoid Arthritis
- Abstract #AB0420 – Secondary Efficacy Outcomes from a Phase 3 Study Support Clinical Equivalence between BOW015 and Infliximab in Patients with Active Rheumatoid Arthritis on Stable Methotrexate Doses
Copies of the abstracts are available and can be viewed online through the EULAR website at http://www.congress.eular.org/.
About BOW015 (infliximab, reference biologic Remicade)
EPIRUS’ lead and most advanced program, BOW015 is a monoclonal antibody against tumor necrosis factor alpha (TNF-α). 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 recently signed a distribution deal with mAbxience.
For US and Europe, EPIRUS plans to initiate a global clinical program in late 2015 / early 2016 to support a harmonized global filing for BOW015 in 2017.
About EPIRUS Biopharmaceuticals, Inc.
EPIRUS Biopharmaceuticals (Nasdaq:EPRS) is a global biosimilar company focused on improving patient access to important medicines. EPIRUS' operationally synergistic pipeline of biosimilar product candidates includes BOW015 (infliximab), BOW050 (adalimumab) and BOW070 (tocilizumab). The reference products for these candidates -- Remicade®, Humira® and Actemra®, respectively -- together generated $23 billion in global sales for 2014, according to EvaluatePharma®. EPIRUS has developed distinct strategies to access its targeted markets with the goal to build a profitable and sustainable biosimilar business. For more information visit EPIRUS’ website at www.epirusbiopharma.com.
Remicade is a registered trademark of Johnson and Johnson (www.jnj.com)
Humira is a registered trademark of AbbVie (www.abbvie.com)
Actemra is a registered trademark of Chugai Seiyaku Kabushiki Kaisha Corp., a member of the Roche Group (www.gene.com)
Infimab is a registered trademark of Sun Pharma (www.sunpharma.com)
Forward-Looking Statements
Various statements in this release are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. In addition, when or if used in this document, the words “may,” “could,” “should,” “anticipate,” “believe,” “estimate,” “expect,” “intend,” “plan,” “predict” and similar expressions and their variants, as they relate to EPIRUS or its management may identify forward-looking statements. EPIRUS cautions that these forward-looking statements are subject to numerous assumptions, risks, and uncertainties, which change over time. Important factors that may cause actual results to differ materially from the results discussed in the forward-looking statements or historical experience include risks and uncertainties, including the failure by EPIRUS to secure and maintain relationships with collaborators and single-source contract manufacturers; risks relating to clinical trials; risks relating to the commercialization, if any, of EPIRUS’ proposed product candidates (such as marketing, regulatory, product liability, supply, competition, and other risks); dependence on the efforts of third parties; dependence on intellectual property; risks related to the loss of any of EPIRUS’ key management personnel; risks that EPIRUS may lack the financial resources and access to capital to fund proposed operations and other factors that are described in the “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of EPIRUS’ annual report on Form 10-K for the fiscal year ended December 31, 2014 which is on file with the SEC and available on the SEC’s website at www.sec.gov. In addition to the risks described above and in EPIRUS’ annual report on Form 10-K, quarterly reports on Form 10-Q, current reports on Form 8-K and other filings with the SEC, other unknown or unpredictable factors also could affect EPIRUS’ results. There can be no assurance that the actual results or developments anticipated by EPIRUS will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, EPIRUS. Therefore, no assurance can be given that the outcomes stated in such forward-looking statements and estimates will be achieved.
All written and verbal forward-looking statements attributable to EPIRUS or any person acting on its behalf are expressly qualified in their entirety by the cautionary statements contained or referred to herein. EPIRUS cautions investors not to rely too heavily on the forward-looking statements EPIRUS makes or that are made on its behalf. The information in this release is provided only as of the date of this release, and EPIRUS undertakes no obligation, and specifically declines any obligation, to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise.