EPIRUS Biopharmaceuticals Provides Clinical Program Update on BOW015 (Infliximab Biosimilar)
16 Noviembre 2015 - 5:05AM
EPIRUS Biopharmaceuticals, Inc. (Nasdaq:EPRS), a
biopharmaceutical company focused on the global development and
commercialization of biosimilar monoclonal antibodies (mAbs), today
announced the completion of manufacturing process lock and
readiness for initiation of its pivotal global registration study.
EPIRUS plans to initiate a global registration study for BOW015
(infliximab, reference biologic Remicade®ii) in active
Rheumatoid Arthritis (RA) patients in the United States, Europe and
other markets in the first quarter of 2016. The company is on track
for a harmonized global filing for marketing approval for
BOW015 in 2017.
“A foundational step in biosimilar development is
process development and manufacturing process lock to establish
biosimilarity and manage long term cost of goods,” said Amit
Munshi, president and chief executive officer, EPIRUS
Biopharmaceuticals. “We believe the combination of the enhanced
product profile and improved titers resulting from our recent
process development efforts, the upcoming global registration study
and the existing clinical and market experience, will create a
strong regulatory package for Europe, Canada and the United
States.”
EPIRUS continues to compile a comprehensive data
package that will serve as the basis for the global filing. The
forthcoming global registration study will build on positive data
from EPIRUS' Phase 1 study in healthy volunteers conducted in the
United Kingdom and Phase 3 study in active RA patients, which were
presented at recent American College of Rheumatology (ACR) and
European League Against Rheumatism (EULAR) meetings. These data
reinforce the pharmacokinetic, safety and efficacy profile for
BOW015, which further demonstrate the biosimilarity between BOW015
and Remicade. To date, between the clinical and market
experience, nearly 750 patients have 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 recent filings in Indonesia, Malaysia and Thailand.
A harmonized global filing for marketing approval in Europe, Canada
and the United States is targeted in 2017.
About EPIRUS
BiopharmaceuticalsEPIRUS Biopharmaceuticals (Nasdaq:EPRS)
is a biopharmaceutical 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. EPIRUS' 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. For more information visit EPIRUS’
website at www.epirusbiopharma.com.
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 and June 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.
Source: EPIRUS Biopharmaceuticals, Inc.
i As reported by EvaluatePharma® for 2014
innovator sales
ii 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); Stelara is owned and marketed by Centocor Ortho
Biotech Inc, a wholly owned subsidiary of Johnson and Johnson
(www.jnj.com); Simponi is marketed by Janssen Biotech Inc
(www.janssenbiotech.com); Soliris is a registered trademark of
Alexion Pharmaceuticals, Inc. (www.alxn.com)
Contact Information:
For investor inquiries:
Tom Shea, EPIRUS Biopharmaceuticals
+1-617-600-3471
tshea@epirusbiopharma.com
For media inquiries:
Mike Devine, FleishmanHillard
+1-212-453-2324
michael.devine@fleishman.com
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