EPIRUS Biopharmaceuticals, Inc. (Nasdaq:EPRS), a pure-play
biosimilar company focused on the development and commercialization
of biosimilar monoclonal antibodies (mAbs), today announced the
initiation of its global registration study for BOW015 (infliximab,
reference biologic Remicade®ii) in active Rheumatoid Arthritis (RA)
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.
The UNIFORM Study is a 58-week, double-blind,
one-to-one randomized, comparator-controlled multi-center global
study to compare efficacy, safety and immunogenicity and
demonstrate clinical equivalence of BOW015 with Remicade. 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). EPIRUS is targeting a harmonized global
filing for marketing approval for BOW015 in 2017 based on 30-week
data.
“The initiation of the UNIFORM Study is a major
milestone for the BOW015 biosimilar clinical program,” said Amit
Munshi, president and chief executive officer, EPIRUS
Biopharmaceuticals. “Following completion last quarter of
manufacturing process lock, which we believe is an important
risk-reducing milestone in our development program, our team
continues to make progress toward market entry in the United States
and Europe. This study, along with patient exposure and
pharmacovigilance data from patients currently receiving treatment,
is designed to provide the foundation for our global filing.”
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.
About BOW015 (infliximab, reference
biologic Remicade)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.
About EPIRUS Biopharmaceuticals
EPIRUS Biopharmaceuticals (Nasdaq:EPRS) is a pure-play
biosimilar company focused on the global development and
commercialization of biosimilar monoclonal antibodies (mAbs).
EPIRUS' goal is to improve global patient access to important,
cost-effective medicines. The company’s current pipeline of
biosimilar product candidates
includes: BOW015 (infliximab, reference biologic
Remicade®); BOW050 (adalimumab, reference biologic
Humira®); BOW070 (tocilizumab, reference biologic
Actemra®); BOW080 (eculizumab, reference biologic
Soliris®); BOW090 (ustekinumab, reference biologic
STELARA®); and BOW100 (golimumab, reference biologic
SIMPONI®)ii. The reference products for these candidates together
generated approximately $29.2 billion in global sales for
2014, according to EvaluatePharma®. EPIRUS has established multiple
partnerships to support its regulatory and commercialization
efforts in global markets.
Forward-Looking StatementsVarious
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 in-house cell line and
process development activities; 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 and quarterly reports on Form
10-Q for the quarters ended March 31, 2015, June 30, 2015 and
September 30, 2015, which are 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.
i UNIFORM Study –
Understanding BOW015
(infliximab-EPIRUS) and reference
infliximab (Remicade®) in patients with active
rheumatoid arthritis on stable
doses of methotrexate
ii Remicade is a registered trademark of
Johnson and Johnson; Humira is a registered trademark of AbbVie;
Actemra is a registered trademark of Chugai Seiyaku Kabushiki
Kaisha Corp., a member of the Roche Group; Stelara is owned and
marketed by Centocor Ortho Biotech Inc, a wholly owned subsidiary
of Johnson and Johnson; Simponi is marketed by Janssen Biotech Inc;
Soliris is a registered trademark of Alexion Pharmaceuticals,
Inc.
Contact Information:
For media inquiries:
Hope Buggey, FleishmanHillard
+1-919-336-3786
hope.buggey@fleishman.com
For investor inquiries:
Marek Ciszewski, J.D., EPIRUS Biopharmaceuticals
+1-617-553-9716
mciszewski@epirusbiopharma.com
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