- Profit-sharing
collaboration focused on the commercialization of EPIRUS'
biosimilars pipeline in EU, Middle East, Turkey, Russia and CIS
territories ("Territories")
- EPIRUS retains
commercial rights to Switzerland, Norway, Austria, Belgium,
Denmark, Finland, Luxembourg, the Netherlands and Sweden
- Call to be hosted
today at 9 a.m. ET
BOSTON, July 14, 2015 (GLOBE NEWSWIRE)
-- EPIRUS Biopharmaceuticals,
Inc. (Nasdaq:EPRS) and Polpharma Group today
announced the signing of a multi-product, multi-region
profit-sharing collaboration for select EPIRUS biosimilars,
including BOW015(infliximab, reference biologic
Remicade®), BOW050 (adalimumab, reference biologic
Humira®) and BOW070 (tocilizumab, reference biologic
Actemra®), representing $6 billion in innovator sales in the
specified territoriesi. Polpharma Group is a leading generics
company based in Poland with annual sales of approximately $1
billion and a strong commercial infrastructure, including a
salesforce of over 1,700 employees globally.
With EPIRUS leading the global
product development and clinical programs, both parties will
jointly fund clinical development and collaborate on regulatory
filings in the specified territories. EPIRUS will also be
responsible for process development, scale-up and manufacturing,
with Polpharma Group overseeing commercialization across the
territories. Clinical development costs and eventual operating
profit will be split 51 percent Polpharma Group and 49 percent
EPIRUS. Polpharma Group will contribute approximately $30 million
towards clinical development costs, as well as cover product launch
costs across all three programs.
"This profit-sharing collaboration
with Polpharma Group enables us to better direct our business and
retain future value," said Amit Munshi, president and chief
executive officer, EPIRUS Biopharmaceuticals. "We have an
aggressive plan to bring our products to markets globally and to
build a pure-play, sustainable and profitable biosimilar business.
To achieve this goal, we need an equally aggressive partner with
aligned objectives. Polpharma Group is rooted in over 80 years of
experience in highly competitive global markets with complex
generics. They have already made a substantial commitment to the
biosimilar space with a vision to expand."
EPIRUS retains the commercial
rights to Switzerland and Norway along with select EU countries
including Austria, Belgium, Denmark, Finland, Luxembourg, the
Netherlands and Sweden, allowing the Company to build its direct
commercial footprint. EPIRUS also retains rights to North America
and other global markets not addressed in this agreement. A joint
management board will oversee the collaboration.
"Partnering with EPIRUS allows us
to combine their technical expertise with our commercial strength,"
said Jerzy Starak, chairman of the supervisory board, Polpharma
Group. "We are pleased to join the experience of both teams and the
potential of these markets to provide patients with more affordable
access to modern treatment."
Conference
Call and Webcast Information:
The EPIRUS leadership team will host a conference call and webcast
today, July 14, 2015 at 9 a.m. Eastern Time. To access the
conference call, please dial 1-855-638-3957 (United States) or
1-224-633-1318 (International).The conference ID is 81626670. The
webcast can be accessed on EPIRUS' website
at www.epirusbiopharma.com. 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 focused on building a pure-play, sustainable, profitable
biosimilar business. As such, EPIRUS will be able 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®)
and BOW070 (tocilizumab, reference biologic Actemra®).
The reference products for these candidates together generated $23
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.
About
Polpharma Group
Polpharma Group is a leading generics player based in Poland,
operating across Europe, the Caucasus and Central Asia, with
manufacturing subsidiaries in Russia and Kazakhstan. Polpharma
Group is among the top 20 generic drug manufacturers in the world
with annual sales of approximately $1 billion. Polpharma Group's
portfolio includes about 600 products with another 200 in pipeline.
It is also one of the leading European API producer delivering
products for pharmaceutical companies worldwide. In order to
provide patients with more affordable access to modern biologic
drugs, Polpharma Group has decided to focus on biosimilar products.
It has created a state-of-the-art R&D and production center,
and established strategic partnerships in addition to expanding its
capabilities in the development and commercialization of
biosimilars. For more information visit Polpharma Group's website
atwww.polpharma.pl/en.
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
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 which is 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 As reported by EvaluatePharma® for 2014
innovator sales; Remicade is a registered trademark of J&J;
Humira is a registered trademark of AbbVie; ACTEMRA is a registered
trademark of Chugai Seiyaku Kabushiki Kaisha Corp., a member of the
Roche Group.