Coherus Announces Topline Results of CHS-1701 Pharmacokinetic and Pharmacodynamic Biosimilarity Study

Coherus BioSciences, Inc.

, 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.