EPIRUS Biopharmaceuticals, Inc. (Nasdaq:EPRS), a biosimilar
company focused on the global development and commercialization of
biosimilar monoclonal antibodies (mAbs), today announced
reprioritization of the company’s pipeline to focus exclusively on
developing biosimilars for the treatment of rare diseases.
This includes reallocating the Company’s resources to focus on the
development of BOW080 (eculizumab; reference biologic Soliris®) for
the potential treatment of ultra-rare blood disorders and BOW070
(tocilizumab; reference biologic Actemra®) for the potential
treatment of an uncommon lymphoproliferative disorder known as
Castleman’s disease.
With the prioritization of the Company’s rare
disease biosimilar assets, EPIRUS will suspend lead program BOW015
(infliximab, reference biologic Remicade®) and work to further
evaluate strategic options for the program, which may include
partnerships, divestitures and/or other value-generating
alternatives. The Company’s decision to suspend its BOW015 program
is based on cost-savings, not technical reasons, and the program
remains ready to commence its planned global Phase 3 clinical
study. The focus on high-value biosimilars that treat rare diseases
also necessitates a restructuring of operations and elimination up
to approximately 40 percent of positions in the Company’s
workforce. The Company is taking this action in response to the
evolving biosimilar competitive and business landscape, in order to
focus on markets that are more targeted and may yield marketed
products through a more capital-efficient development pathway.
Additionally, effective immediately, Amit Munshi
has stepped down as president, chief executive officer and as a
member of the Company’s board. Scott Rocklage, Ph.D., a
current Company board member, managing partner at 5AM Ventures and
founding chief executive officer of Cubist Pharmaceuticals, has
been appointed chief executive officer. Michael Wyand, DVM, Ph.D.,
the Company’s current chief technology officer and a key force in
building the rare disease pipeline, has been promoted to president
and chief operating officer.
“Amit has been instrumental in establishing EPIRUS as a
leading biosimilar company,” said Scott Rocklage, Ph.D., chief
executive officer, EPIRUS Biopharmaceuticals. “We appreciate
his very significant contributions to our business over his four
years at EPIRUS.”
“We are extremely excited to focus on rare diseases and
this represents a significant milestone for both the Company and
the community, as there exists an unmet need for cost-effective
therapies in the rare disease space,” said Michael Wyand, DVM
Ph.D., president, EPIRUS Biopharmaceuticals. “Our initial
market research with hematologists indicates that physicians are
receptive to, and likely to prescribe biosimilars for, rare
diseases. We look forward to paving the way for biosimilars
focused in rare diseases.”
About EPIRUS EPIRUS
Biopharmaceuticals (NASDAQ:EPRS) is a biosimilar company
focused on the global development and commercialization of rare
disease 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: BOW070 (tocilizumab, reference
biologic Actemra®); BOW080 (eculizumab, reference
biologic Soliris®); and additional undisclosed assets. The
projected innovator or class sales for these products are estimated
at almost $6 billion in global sales in 2020, according to
EvaluatePharma®.
About BOW080 and BOW070BOW080
(eculizumab; reference biologic Soliris®) is a complement inhibitor
being evaluated for the potential treatment of ultra-rare blood
disorders such as, paroxysmal nocturnal hemoglobinuria (PNH) and
atypical hemolytic uremic syndrome (aHUS). BOW070
(tocilizumab; reference biologic Actemra®), an immunosuppressive
drug, will be solely focused on the potential treatment for an
uncommon lymphoproliferative disorder known as Castleman’s
disease.
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, such as EPIRUS'
ability to access sufficient capital resources in the near term to
fund its operations, including the rare disease biosimilar
activities described in this press release, as to which EPIRUS can
provide no assurance. 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 risk that EPIRUS may lack the
financial resources and access to capital to fund proposed
operations; risks associated with the change in EPIRUS’ strategy to
focus solely on rare diseases; 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
development; 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; 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,
2015 and other SEC filings, 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. Remicade is a registered trademark of Johnson and
Johnson; Actemra is a registered trademark of Chugai Seiyaku
Kabushiki Kaisha Corp., a member of the Roche Group; and Soliris is
a registered trademark of Alexion Pharmaceuticals, Inc.
Contact Information:
For media inquiries:
Jayme Owen, FleishmanHillard
+1-434-282-2033
+1-919-986-1484
jayme.owen@fleishman.com
For investor inquiries:
Marek Ciszewski, J.D., EPIRUS Biopharmaceuticals
+1-617-553-9716
mciszewski@epirusbiopharma.com
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