Coherus BioSciences Completes two Pharmacokinetic Bioequivalence Studies of CHS-0214
October 06 2016 - 4:09PM
Coherus BioSciences, Inc. (Nasdaq:CHRS) a leading pure-play, global
biosimilar company with late-stage clinical products, today
announced results from two pharmacokinetic (PK) studies involving
CHS-0214, a biosimilar candidate to etanercept (Enbrel®).
CHS-0214-06 (‘06 Study) was a Phase 1 pharmacokinetic
bioequivalence (PK BE) study comparing CHS-0214 vs. European Union
(EU) Enbrel. The ‘06 Study achieved the primary PK BE
endpoint, as the 90% confidence intervals for the geometric mean
ratio for the two groups was within 80% to 125% for all PK
parameters.
CHS-0214-07 (‘07 Study) is an additional, non-pivotal, Phase 1
bridging study. As anticipated, this study provided additional
relative bioavailability data for CHS-0214. As planned, Coherus is
moving forward with pre-submission meetings, now expected in the
first quarter 2017, to review the complete CHS-0214 program prior
to filing. The planned marketing authorizations submissions
will occur directly thereafter.
“Coherus has successfully completed five clinical studies with
CHS-0214 demonstrating similarity to Enbrel, including two pivotal
Phase 3 studies in two separate indications and three PK studies.
We look forward to discussing all data with EU regulators in the
context of the overall program at the upcoming pre-submission
meeting in preparation for the filing,” said Denny Lanfear,
President and Chief Executive Officer of Coherus BioSciences.
About Coherus BioSciences, Inc.
Coherus is a leading pure-play, global biosimilar company that
develops and commercializes high-quality therapeutics for major
regulated markets. Biosimilars are intended for use in place of
existing, branded biologics to treat a range of chronic and often
life-threatening diseases, with the potential to reduce costs and
expand patient access. Composed of a team of proven industry
veterans with world-class expertise in process science, analytical
characterization, protein production and clinical-regulatory
development, Coherus is positioned as a leader in the global
biosimilar marketplace. Coherus is advancing three late-stage
clinical products towards commercialization, CHS-1701
(pegfilgrastim biosimilar), CHS-0214 (etanercept biosimilar) and
CHS-1420 (adalimumab biosimilar), as well as developing a robust
pipeline of future products in four therapeutic areas, oncology,
immunology (anti-TNF), ophthalmology and multiple sclerosis. For
additional information, please visit www.coherus.com.
Forward-Looking
StatementsExcept for the historical information contained
herein, the matters set forth in this press release, including
statements regarding Coherus’ plans, potential opportunities
including market opportunities, expectations, goals, objectives,
strategies, product pipeline, clinical studies, product
development, and the potential benefits of its products under
development are forward-looking statements within the meaning of
the "safe harbor" provisions of the Private Securities Litigation
Reform Act of 1995, including Coherus’ ability to obtain market
authorizations for CHS-0214 in Europe. Such forward-looking
statements involve substantial risks and uncertainties that could
cause our clinical development programs, future results,
performance or achievements to differ significantly from those
expressed or implied by the forward-looking statements. Such risks
and uncertainties include, among others, the uncertainties inherent
in the clinical drug development process, including the regulatory
approval process, the timing of our regulatory filings and other
matters that could affect the availability or commercial potential
of our biosimilar drug candidates, as well as possible patent
litigation. Coherus undertakes no obligation to update or revise
any forward-looking statements. For a further description of
the risks and uncertainties that could cause actual results to
differ from those expressed in these forward-looking statements, as
well as risks relating to Coherus’ business in general, see
Coherus’ Quarterly Report on Form 10-Q for the quarter ended June
30, 2016, filed with the Securities and Exchange Commission on
August 9, 2016 and its future periodic reports to be filed with the
Securities and Exchange Commission.
Enbrel® is a registered trademark of Amgen,
Inc.
Contact:
Patrick O’Brien
Senior Vice President, Investor Relations
Coherus BioSciences, Inc.
pobrien@coherus.com
+1 (650) 649-3527
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