Coherus BioSciences, Inc. (NASDAQ:CHRS), a leading pure-play,
global biosimilars company with late-stage clinical products, today
reported the results from its pharmacokinetic and pharmacodynamic
(PK/PD) clinical study of CHS-1701, a pegfilgrastim (Neulasta®)
biosimilar candidate. This study met its primary PD endpoints of
absolute neutrophil count (ANC). In terms of PK parameters, the
study also met bioequivalence for Cmax. The Area Under the Curve
(AUC) portion of the PK results are still under review. Given these
overall positive results, Coherus remains on track for its planned
BLA filing in the first quarter of 2016.
This randomized, double-blind, single-dose, two-period crossover
study in healthy subjects assessed PK, PD, and safety of a single 6
mg subcutaneous (SC) injection of CHS-1701 compared with a
single 6 mg SC dose of Neulasta. A total of 116 healthy volunteer
subjects were randomized to one of two treatment sequences;
Neulasta (Period 1) then CHS-1701 (Period 2) or CHS-1701 (Period 1)
then Neulasta (Period 2).
PD results: All four treatment groups
performed as expected and the study met both PD endpoint measures
of absolute neutrophil count (ANCmax, ANC AUC). Data below.
A graph accompanying this release is available at
http://media.globenewswire.com/cache/33333/file/37779.pdf
PK results: Three of the four treatment
groups, which included both of the CHS-1701 treatment groups and
the Period 2 Neulasta group, performed as expected, consistent with
previously published studies1. The PK maximum concentration
(Cmax) endpoint of the study met bioequivalence. A low, anomalous
PK profile in the Period 1 Neulasta group resulted in not meeting
bioequivalence in the area-under-the-curve (AUC) endpoints
(AUC0-to-288, AUC0-to-Inf, AUCLast). This anomalous result is being
investigated. Data below.
An additional graph accompanying this release is available at
http://media.globenewswire.com/cache/33333/file/37780.pdf In
cooperation with the U.S. Food and Drug Administration (FDA),
Coherus is investigating the root cause of the low, anomalous
Period 1 Neulasta PK results, and is working closely and in
parallel with the FDA on further analyzing all the data from the
study.
Dosing: Syringes were weighed prior to and
after study drug administration. An analysis of delivered doses
showed less than a 1% difference between the test articles for the
respective cohorts. Such minor differences in dosing are highly
unlikely to be the cause of the low abnormal Neulasta Period 1 PK
profile.
Safety summary: In terms of any
drug-related adverse events, the safety profile was equivalent
between the CHS-1701 and Neulasta treatment arms.
Antibody Assays: No neutralizing antibodies
were identified in either treatment cohort.
"We have shared the topline results with the FDA including the
anomalous Neulasta Period 1 AUC profile," said Barbara Finck, M.D.,
Chief Medical Officer of Coherus. "Based on this topline data, the
FDA has not recommended initiating a repeat of this study. The
Agency has further indicated that even if the root cause of the
Neulasta Period 1 findings is not fully elucidated, the study may
support our biologics license application, as their review will be
predicated on the totality of the evidence submitted."
"We believe the overall positive results of this study, together
with the immunogenicity study which has recently completed
enrollment, support our plan to submit the 351(k) BLA in the first
quarter of 2016, consistent with our previous guidance," said Denny
Lanfear, President and Chief Executive Officer of Coherus.
Coherus will hold a conference call on Thursday, October 1, 2015
at 5:30 p.m. ET.
Conference Call Information
Dial-in: (844) 452-6826 (domestic) or
(765) 507-2587 (international) Conference ID: 52383263
Please join the conference call at least 10 minutes early to
register.
The webcast of the conference call will be available for replay
through October 16, 2015.
About Coherus BioSciences, Inc.
Coherus is a pure-play 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. For additional information, please
visit www.coherus.com.
Forward Looking Statements
To the extent that statements contained in this press release
are not descriptions of historical facts regarding Coherus, they
are forward-looking statements reflecting the current beliefs and
expectations of management made pursuant to the safe harbor
provisions of the Private Securities Litigation Reform Act of 1995,
including statements regarding the ability of Coherus to complete a
BLA-enabling clinical program for CHS-1701, its ability to complete
a root cause analysis of the PK deviation observed in its CHS-1701
PK/PD study and to submit a BLA on its desired timeline, and the
acceptability to the FDA of Coherus' BLA submission for CHS-1701.
Such forward-looking statements involve substantial risks and
uncertainties that relate to future events and the actual results
could differ significantly from those expressed or implied by the
forward-looking statements. Such risks and uncertainties include,
among others, the uncertainties inherent in the biosimilar
development process, including the regulatory approval process, the
timing of the actions of regulatory bodies and other governmental
authorities, clinical results, changes in laws and regulations,
product quality or supply for our clinical material and patient
safety. 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 the business of the company in general,
see the company's current and future reports filed with the U.S.
Securities and Exchange Commission, including its Quarterly Report
on Form 10-Q for the quarterly period ended June 30, 2015.
Neulasta® is a registered trademark of Amgen Inc.
Reference
1. Yang B., Cancer Chemotherapy Pharmacology (2015)
CONTACT: Keith Vendola, M.D.
Investor relations
Coherus BioSciences, Inc.
kvendola@coherus.com
+1 (650) 437-6239
Coherus BioSciences (NASDAQ:CHRS)
Historical Stock Chart
From Apr 2024 to May 2024
Coherus BioSciences (NASDAQ:CHRS)
Historical Stock Chart
From May 2023 to May 2024