EPIRUS Biopharmaceuticals, Inc. (EPIRUS, NASDAQ: EPRS),
a Boston-based biopharmaceutical company focused on the global
development and commercialization of biosimilar monoclonal antibodies,
announced today that it has signed a royalty-bearing, multi-product
collaboration agreement with Livzon Mabpharm Inc. (Livzon), a Chinese
biotechnology company focused on the development, manufacture, and sale
of antibody-based drugs. Livzon was also a principal investor in the $36
million private financing round EPIRUS closed in April 2014, prior to
becoming a public company.
Under the terms of the agreement, EPIRUS and Livzon will work together
to develop, manufacture, and commercialize up to five biosimilar
products. The first collaboration product is EPIRUS’ Remicade biosimilar
BOW015 (infliximab), which was recently approved in India. Livzon will
conduct any additional development work necessary for the approval of
BOW015 in China and Taiwan. Livzon will also serve as the preferred
supplier of BOW015 in these territories, following a transfer of EPIRUS’
SCALE™ manufacturing platform. Livzon will be responsible for all
commercialization activities in its territories.
“We have established a significant collaboration with a strong partner
in a compelling market,” said Amit Munshi, president and CEO of EPIRUS.
“This agreement also reinforces the importance of our SCALE™
manufacturing platform for in market production globally.”
Daotian Fu, Ph.D., CEO of Livzon Mabpharm, Inc., said, “EPIRUS’ robust
pipeline, business strategy and experienced management coupled with the
market potential of biosimilars, made this an exciting collaboration for
Livzon. We look forward to building a substantial biosimilars business
for the China market.” Dr. Fu is also a member of the EPIRUS board of
directors.
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’ strategy for commercial success relies on targeted approaches
for diverse global markets.
For emerging markets with accessible regulatory frameworks for
biosimilars, EPIRUS develops partnerships with local companies to
accelerate regulatory approval and commercialize its products.
For high-growth global 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.
For large 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.
More information about EPIRUS can be found at www.epirusbiopharma.com
About 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
previously 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. Recently, Epirus announced 58 week data for its Phase
3 trial, which demonstrated therapeutic equivalence to Remicade and
confirmed the safety of switching from Remicade to BOW015.
More data on the Phase 3 study is available at www.abstracts2view.com/eular/.
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 Livzon Mabpharm, Inc.
Founded in 2010, Livzon Mabpharm, Inc. is one of the major biotechnology
companies to enter biologics research and development in China. It is
mainly focused on development, manufacturing and sale of antibody-based
drugs. It is equipped with a world-class technical and scientific
research team, core technology platforms, and advanced R&D facilities.
The company’s controlling shareholder is Livzon Pharmaceutical Group,
Inc. (“Livzon”, a pharmaceutical listed company in Mainland China and in
Hong Kong (Stock code:000513.SZ, 01513.HK)), which holds 51% shares of
Livzon Mabpharm, Inc. Livzon is a diversified pharmaceutical enterprise
integrating development & research, production and sales of
pharmaceutical products, operating to manufacture drug products, bulk
medicines and intermediates, as well as diagnostic reagents and
equipment. Livzon Mabpharm, Inc. was founded as the strategic R&D
transformation of Livzon Pharmaceutical Group. Inc., focusing on
development of antibody based drugs and vaccines.
More information about Livzon can be found at www.livzon.com.cn.
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 development and
prospects of BOW015 and EPIRUS’ collaboration with Livzon, 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.
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
duty or 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)
Copyright Business Wire 2014