Coherus Presents Study Results Demonstrating Equivalence of its CHS-0214 Biosimilar to Etanercept
(Thomson Reuters ONE) -
Biosimilar to etanercept meets primary endpoint
REDWOOD CITY, Calif., June 10, 2016 (GLOBE NEWSWIRE) -- Coherus BioSciences,
Inc. (Nasdaq:CHRS), a leading pure-play, global biosimilars company with late-
stage clinical products, today announced the release of study data demonstrating
the equivalence of Coherus' etanercept biosimilar (CHS-0214) to Enbrel®
(etanercept), the reference product, with respect to efficacy as measured by the
primary endpoint, ACR20 at 24 weeks.
The study data was released today at the European League Against Rheumatism
Annual European Congress of Rheumatology held in London, United Kingdom.
As a part of the study, the research team conducted a randomized, double-blind,
two-part study in patients with moderate to severe rheumatoid arthritis and an
inadequate response to methotrexate and who were naïve to biologic therapies.
Results of the study demonstrated the equivalence of CHS-0214 to etanercept with
respect to efficacy as measured by a primary endpoint. Additionally, secondary
endpoints supported equivalence of CHS-0214 to etanercept. There were no
clinically meaningful differences between CHS-0214 and etanercept with regard to
safety and immunogenicity.
"We are very pleased by the results of this particular study as it relates to
demonstrating the safety and efficacy of our etanercept biosimilar," said Dr.
Barbara Finck, Chief Medical Officer, Coherus BioSciences. "We look forward to
continued positive results for this particular product as we move forward on the
market approval pathway."
About Coherus BioSciences, Inc.
Coherus is a leading pure-play global biosimilar platform 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, including CHS-5217 (bevacizumab biosimilar) and CHS-3351 (ranibizumab
biosimilar). For additional information, please visit www.coherus.com.
Forward-Looking Statements
Except for the historical information contained herein, the matters set forth in
this press release, including statements regarding Coherus' plans, potential
opportunities, expectations, projections, goals, objectives, milestones,
strategies, product pipeline, clinical studies, product development, release of
data 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 marketing approval for CHS-0214. 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' Annual Report on Form 10-Q for the quarter
ended March 31, 2016, filed with the Securities and Exchange Commission on May
9, 2016 and its future periodic reports to be filed with the Securities and
Exchange Commission.
Enbrel® is registered trademarks of Amgen Inc.
CONTACT:
INVESTOR RELATIONS:
Patrick O'Brien
Coherus BioSciences, Inc.
pobrien(at)coherus.com
+1 (650) 649-3527
MEDIA:
Megan Humphreys
McBee Strategic
mhumphreys(at)mcbeestrategic.com
+1 (202) 465-7753
This announcement is distributed by GlobeNewswire on behalf of
GlobeNewswire clients. The owner of this announcement warrants that:
(i) the releases contained herein are protected by copyright and
other applicable laws; and
(ii) they are solely responsible for the content, accuracy and
originality of the information contained therein.
Source: Coherus BioSciences via GlobeNewswire
[HUG#2019436]
Unternehmensinformation / Kurzprofil:
Datum: 10.06.2016 - 18:05 Uhr
Sprache: Deutsch
News-ID 477046
Anzahl Zeichen: 5708
contact information:
Town:
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Kategorie:
Business News
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