Release Details
Coherus Provides Updates on Clinical Studies
Increases Enrollment in CHS-1701 Immunogenicity Study
Initiated Enrollment in CHS-1420 Phase 3 Study
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CHS-1701 (pegfilgrastim (Neulasta®) 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.
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CHS-1420 (adalimumab (Humira®) 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®) 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
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. |
About
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 obtain regulatory approval from the
Enbrel® and Neulasta® are registered trademarks of
HUMIRA® is a registered trademark of
CONTACT:Keith Vendola , M.D. Investor relationsCoherus BioSciences, Inc. kvendola@coherus.com +1 (650) 437-6239