EPIRUS Biopharmaceuticals, Inc. (Nasdaq:EPRS), a biosimilar company
focused on the global development and commercialization of
biosimilar monoclonal antibodies (mAbs), today announced an
agreement for the acquisition of Bioceros Holding B.V., enabling
EPIRUS to expand its biosimilar pipeline and vertically integrate
product development capabilities.
Bioceros is a privately-held, Netherlands-based
biopharmaceutical R&D company focused on the development of
mAbs and generation of GMP-ready cell lines. Over the past decade,
Bioceros has developed numerous biosimilar cell lines from its
proprietary, well-characterized CHO platform (CHOBC®)i.
Bioceros’ staff of scientists, fully-equipped labs and bioreactor
capabilities have been designed for the development of
mAbs and protein therapeutics, with a focus on
biosimilars.
From the Bioceros platform, EPIRUS will expand
its pipeline with the addition of three preclinical product
candidates: BOW080, a proposed biosimilar to eculizumab (reference
biologic Soliris®); BOW090, a proposed biosimilar to ustekinumab
(reference biologic STELARA®); and BOW100, a proposed biosimilar to
golimumab (reference biologic SIMPONI®). Soliris, marketed by
Alexion Pharmaceuticals, is currently indicated to treat ultra-rare
blood disorders, including paroxysmal nocturnal hemoglobinuria
(PNH) and atypical hemolytic uremic syndrome (aHUS).
SIMPONI and STELARA are marketed by Janssen
Pharmaceuticals and indicated in inflammatory and immune mediated
disorders.
These three new pipeline assets represent a
global growth opportunity for EPIRUS in targeting reference
biologics with estimated 2020 peak sales of $12 billionii.
The platform also enables future pipeline growth opportunities for
EPIRUS. The anticipated filing dates for the three new
pipeline products are 2020 for BOW080, 2021 for BOW090 and 2022 for
BOW100.
“Building a focused, sustainable and profitable
biosimilar business requires capabilities for efficient pipeline
growth. With this in mind, we are excited to welcome Bioceros
and their world-class capabilities and expertise,” said Amit
Munshi, president and chief executive officer, EPIRUS
Biopharmaceuticals. “Together, we will continue working to
improve patient access to important, cost-effective medicines
worldwide. Our combined biosimilar pipeline targets reference
biologics with sales of $29 billion, which we estimate to be a
biosimilar market opportunity of more than $9 billion.”
“Having worked with EPIRUS as a partner over the last several
years, we believe strongly in the Company’s vision and their
ability to execute,” said Bram Bout, Ph.D., chief executive officer
and chairman of the management board, Bioceros. “With our
proven track record, our team brings substantial cell line and
process development experience, representing a strong asset for
EPIRUS.”
Under the terms of the agreement, EPIRUS has acquired Bioceros
for a total consideration of $14.1 million in cash and stock
payable in installments over a one-year period.
Conference Call and Webcast
Information:
EPIRUS’ leadership team will host a conference
call and webcast today, September 9, 2015 at 9:00 a.m. Eastern
Time, to discuss these recent corporate developments. To
access the conference call, please dial 1-855-638-3957 (United
States) or 1-224-633-1318 (International). The conference ID
is 32375668. The webcast can be accessed on EPIRUS’ website
at http://ir.epirusbiopharma.com/events.cfm. Please connect
to either the conference call or webcast at least 10 minutes early
to ensure adequate time to register. The webcast will be
archived on EPIRUS’ website for a period of three months.
About EPIRUS
Biopharmaceuticals
EPIRUS Biopharmaceuticals (Nasdaq:EPRS) is a
biopharmaceutical company building a focused, sustainable and
profitable biosimilar business. EPIRUS’ goal is to improve
patient access to important, cost-effective medicines worldwide.
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®)iii.
The reference products for these candidates together
generated approximately $29.2 billion in global sales for 2014,
according to EvaluatePharma®. EPIRUS has developed distinct
strategies to penetrate the global market, leveraging partnerships
to optimize value retention over the long term. For more
information visit EPIRUS’ website at www.epirusbiopharma.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
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.
i CHOBC is a registered trademark of Bioceros Holding
B.V.
ii As reported by EvaluatePharma (data
pulled August 2015)
iii 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 media inquiries:
Mike Devine, FleishmanHillard
+1-617-692-0507
michael.devine@fleishman.com
For investor inquiries:
Tom Shea, EPIRUS Biopharmaceuticals
+1-617-600-3471
tshea@epirusbiopharma.com
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