Coherus BioSciences,
Inc. CHRS, a leading pure-play, global biosimilars company with
late-stage clinical products, today provided updates on its clinical
programs.
-- CHS-1701 (pegfilgrastim (Neulasta(R)) biosimilar): Coherus has decided
to
increase the total number of healthy subjects to be enrolled in its
immunogenicity study as part of its Biologics License Application (BLA)
enabling clinical program, in concurrence with the U.S. Food and Drug
Administration. This study has a design which allows us to adjust sample
size based on a preliminary blinded look at the overall anti-drug
antibody rate. This immunogenicity study is projected to complete dosing
in the fourth quarter of 2015 to support submission of the 351(k)
(biosimilar) license application in the first quarter of 2016, within
the
range of prior guidance. Coherus anticipates top-line data from its
pharmacokinetic and pharmacodynamic (PK/PD) study of CHS 1701 in the
third quarter of 2015.
-- CHS-1420 (adalimumab (Humira(R)) biosimilar): Coherus has initiated
dosing in its Phase 3 study in psoriasis. Coherus anticipates initiating
the PK bioequivalence bridging study by the end of the first half of
2016
with Phase 3 drug material and file a BLA in the U.S. in the second half
of 2016. These projections are consistent with previous guidance.
-- CHS-0214 (etanercept (Enbrel(R)) biosimilar): Topline data for the
psoriasis Phase 3 study is expected in the fourth quarter of 2015 and
for
the rheumatoid arthritis study in the first quarter of 2016. Coherus
anticipates filing a Marketing Authorization Application (MAA) in the
E.U. in 2016. These projections are consistent with previous guidance.
Coherus will hold a conference call on Thursday, September 3, at 5:00 p.m.
ET.
Conference Call Information
Dial-in: (844) 452-6826 (domestic) or (765) 507-2587
(international)
Conference ID: 31690561
Webcast: http://investors.coherus.com
Please join the conference call at least 10 minutes
early to register.
The webcast of the conference call will be available
for replay through September 16, 2015.
Market News and Data brought to you by Benzinga APIs© 2024 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
Comments
Loading...
Benzinga simplifies the market for smarter investing
Trade confidently with insights and alerts from analyst ratings, free reports and breaking news that affects the stocks you care about.
Join Now: Free!
Already a member?Sign in