EPIRUS Biopharmaceuticals, Inc. (EPIRUS, NASDAQ: EPRS),
a Boston-based biopharmaceutical company focused on the global
development and commercialization of biosimilar monoclonal antibodies,
today announced the launch of its first product, Infimab (BOW015), the
first infliximab biosimilar in India.
Infimab, a Remicade (infliximab) biosimilar, is being launched in
cooperation with EPIRUS’ commercialization partner Ranbaxy Laboratories
Limited (Ranbaxy). Infimab will be manufactured by Reliance Life
Sciences at a facility in Mumbai. Remicade is currently marketed
globally for the treatment of inflammatory diseases including rheumatoid
arthritis, Crohn’s Disease, ankylosing spondylitis, ulcerative colitis,
psoriatic arthritis and psoriasis.
“The launch of Infimab in the fourth quarter of this year is earlier
than anticipated and demonstrates our ability to execute with our
partner,” said Amit Munshi, president and CEO of EPIRUS. “Infimab
represents an affordable solution for patients and may expand patient
access to this important medicine. With this first launch, and a diverse
pipeline in development, we look forward to continuing to provide
solutions for patients globally.”
Under the terms of its licensing agreement with EPIRUS, Ranbaxy has the
rights to commercialize Infimab in other markets in Southeast Asia and
North Africa.
About INFIMAB (BOW015)
BOW015 is a biosimilar version of infliximab, a biologic therapy
marketed under the name Remicade®. EPIRUS has previously
reported positive Phase 1 and Phase 3 clinical data for BOW015. The
Phase 3 trial met its predefined endpoint and demonstrated the
comparability of BOW015 to Remicade, as measured by ACR20 response in
severe rheumatoid arthritis (RA) patients. The study also showed no
meaningful differences between BOW015 and Remicade with regard to safety
or immunogenicity.
More data on the Phase 3 study is available at: http://acrabstracts.org/abstracts/bow015-a-biosimilar-infliximab-in-patients-with-active-rheumatoid-arthritis-on-stable-methotrexate-doses-54-week-results-of-a-randomized-double-blind-active-comparator-study/
EPIRUS is actively progressing applications for marketing approval for
BOW015 in targeted global markets. EPIRUS also plans to initiate an
additional Phase 3 trial in Europe in early 2015.
About EPIRUS
EPIRUS is building a global biosimilar enterprise to improve patient
access to important medicines. EPIRUS' pipeline of biosimilar product
candidates includes BOW015 (infliximab), BOW050 (adalimumab), and BOW030
(bevacizumab). The reference products for these product candidates -
Remicade®, Humira®, and Avastin®,
respectively - together generated $26.2 billion in global sales in 2013.
EPIRUS also has two additional undisclosed preclinical product
candidates.
EPIRUS' strategy for commercial success relies on targeted approaches
for diverse global markets.
For Developed Markets with an established biosimilar regulatory
framework, such as Europe, EPIRUS plans to commercialize its products
using a combination of direct sales and local distributors.
For Accessible Markets with accessible regulatory frameworks for
biosimilars, EPIRUS develops partnerships with local companies to
accelerate regulatory approval and commercialize its products.
For high-growth Local Production Markets where local manufacturing
confers strategic and operational advantages, EPIRUS intends to use its
SCALE™ platform to deliver an In Market, For Market™ manufacturing
solution with local partners.
More information about EPIRUS can be found at www.epirusbiopharma.com
Forward Looking Statements
Any statements made herein relating to future financial or business
performance, conditions, plans, prospects, trends, or strategies and
other financial and business matters, including the long-term safety and
prospects of BOW015, 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, before or after the recent Zalicus merger, 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; 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; and risks
that EPIRUS may lack the financial resources and access to capital to
fund proposed operations. Further information on the factors and risks
that could affect EPIRUS' business, financial conditions and results of
operations are contained in EPIRUS' filings with the U.S. Securities and
Exchange Commission, which are available at www.sec.gov.
The forward-looking statements represent the estimates of EPIRUS as of
the date hereof only, and EPIRUS specifically disclaims any duty or
obligation to update forward-looking statements.
Other risks and uncertainties are more fully described in EPIRUS'
filings with the U.S. Securities and Exchange Commission, which are
available at www.sec.gov.
Existing and prospective investors are cautioned not to place undue
reliance on these forward-looking statements, which speak only as of the
date hereof. The statements made herein speak only as of the date stated
herein, and subsequent events and developments may cause EPIRUS'
expectations and beliefs to change.
While EPIRUS may elect to update these forward-looking statements
publicly at some point in the future, EPIRUS specifically disclaims any
obligation to do so, whether as a result of new information, future
events or otherwise, except as required by law. These forward-looking
statements should not be relied upon as representing EPIRUS' views as of
any date after the date stated herein.
Remicade® is a registered trademark of Johnson and Johnson (www.jnj.com)
Humira®
is a registered trademark of AbbVie (www.abbvie.com)
Avastin®
is a registered trademark of Genentech (www.gene.com)
Infimab™
is a trademark filed for registration by Ranbaxy Laboratories (www.ranbaxy.com)
Copyright Business Wire 2014