REDWOOD CITY, CA and BANNOCKBURN, IL, USA I November 09, 2015 I Coherus BioSciences, Inc. (NASDAQ:CHRS) and Baxalta Incorporated (NYSE:BXLT) today announced that CHS-0214, a proposed biosimilar of Enbrel® (etanercept), met its primary endpoints in a confirmatory, double-blind, randomized, controlled, two-part Phase 3 study. This on-going 52-week study is evaluating the efficacy and safety of CHS-0214 compared to Enbrel® in patients with moderate-to-severe chronic plaque psoriasis.
“We are pleased with this positive clinical outcome,” said Barbara Finck, M.D., Chief Medical Officer of Coherus. “CHS-0214 is an important option for patients requiring treatment with etanercept. If approved by regulatory agencies, CHS-0214 has the potential to offer patients a high-quality treatment option for conditions for which etanercept is indicated.”
“Achievement of this late-stage clinical milestone further validates the capabilities of our development platform in advancing biosimilar compounds toward approvals within regulated markets,” said Denny Lanfear, President and Chief Executive Officer of Coherus.
The efficacy endpoints were based on a Week 12 assessment of Psoriasis Activity Severity Index (PASI) scores. At Week 12, the primary endpoints, the mean percent change in PASI from baseline and the proportion of subjects achieving 75% improvement in PASI from baseline, were within the pre-specified margins for demonstrating equivalence of CHS-0214 compared to Enbrel®. There were no clinically meaningful differences in the safety profiles of the products.
“We are encouraged by the data from this confirmatory study,” said Dagmar Rosa-Björkeson, Executive Vice President and President, Biosimilars, Baxalta. “Plaque psoriasis has a significant impact on a patient’s quality of life and self-perception, so early access to treatment is imperative. If approved, CHS-0214 would expand access of treatment options for patients with moderate-to-severe chronic plaque psoriasis.”
The study continues as planned until Week 52. The psoriasis study is one of two, large, Phase 3 confirmatory trials intended for inclusion in global marketing applications for CHS-0214. Results for the second Phase 3 study in patients with rheumatoid arthritis are expected in the first quarter of 2016.
Coherus and Baxalta initiated a collaboration to develop and commercialize CHS-0214 in September of 2013.
About CHS-0214, a proposed biosimilar of Enbrel® (etanercept)
CHS-0214 was evaluated in two comprehensive single-dose, cross-over pharmacokinetic / bioequivalence (PK / BE) studies in healthy volunteers. In both trials, CHS-0214 met PK similarity to Enbrel® based on pre-specified pharmacokinetic criteria. The safety profiles of CHS-0214 and Enbrel® were similar in these studies.
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. For additional information, please visit www.coherus.com.
About Baxalta
Baxalta Incorporated (NYSE:BXLT) is a $6 billion global biopharmaceutical leader developing, manufacturing and commercializing therapies for orphan diseases and underserved conditions in hematology, oncology and immunology. Driven by passion to make a meaningful impact on patients’ lives, Baxalta’s broad and diverse pipeline includes biologics with novel mechanisms and advanced technology platforms such as gene therapy. The Baxalta Global Innovation and R&D Center is located in Cambridge, Massachusetts. Launched in 2015 following separation from Baxter International, Baxalta’s heritage in biopharmaceuticals spans decades. Baxalta’s therapies are available in more than 100 countries and it has advanced biological manufacturing operations across 12 facilities, including state-of-the-art recombinant production and plasma fractionation. Headquartered in Northern Illinois, Baxalta employs 16,000 employees worldwide.
SOURCE: Baxalta
Post Views: 48
REDWOOD CITY, CA and BANNOCKBURN, IL, USA I November 09, 2015 I Coherus BioSciences, Inc. (NASDAQ:CHRS) and Baxalta Incorporated (NYSE:BXLT) today announced that CHS-0214, a proposed biosimilar of Enbrel® (etanercept), met its primary endpoints in a confirmatory, double-blind, randomized, controlled, two-part Phase 3 study. This on-going 52-week study is evaluating the efficacy and safety of CHS-0214 compared to Enbrel® in patients with moderate-to-severe chronic plaque psoriasis.
“We are pleased with this positive clinical outcome,” said Barbara Finck, M.D., Chief Medical Officer of Coherus. “CHS-0214 is an important option for patients requiring treatment with etanercept. If approved by regulatory agencies, CHS-0214 has the potential to offer patients a high-quality treatment option for conditions for which etanercept is indicated.”
“Achievement of this late-stage clinical milestone further validates the capabilities of our development platform in advancing biosimilar compounds toward approvals within regulated markets,” said Denny Lanfear, President and Chief Executive Officer of Coherus.
The efficacy endpoints were based on a Week 12 assessment of Psoriasis Activity Severity Index (PASI) scores. At Week 12, the primary endpoints, the mean percent change in PASI from baseline and the proportion of subjects achieving 75% improvement in PASI from baseline, were within the pre-specified margins for demonstrating equivalence of CHS-0214 compared to Enbrel®. There were no clinically meaningful differences in the safety profiles of the products.
“We are encouraged by the data from this confirmatory study,” said Dagmar Rosa-Björkeson, Executive Vice President and President, Biosimilars, Baxalta. “Plaque psoriasis has a significant impact on a patient’s quality of life and self-perception, so early access to treatment is imperative. If approved, CHS-0214 would expand access of treatment options for patients with moderate-to-severe chronic plaque psoriasis.”
The study continues as planned until Week 52. The psoriasis study is one of two, large, Phase 3 confirmatory trials intended for inclusion in global marketing applications for CHS-0214. Results for the second Phase 3 study in patients with rheumatoid arthritis are expected in the first quarter of 2016.
Coherus and Baxalta initiated a collaboration to develop and commercialize CHS-0214 in September of 2013.
About CHS-0214, a proposed biosimilar of Enbrel® (etanercept)
CHS-0214 was evaluated in two comprehensive single-dose, cross-over pharmacokinetic / bioequivalence (PK / BE) studies in healthy volunteers. In both trials, CHS-0214 met PK similarity to Enbrel® based on pre-specified pharmacokinetic criteria. The safety profiles of CHS-0214 and Enbrel® were similar in these studies.
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. For additional information, please visit www.coherus.com.
About Baxalta
Baxalta Incorporated (NYSE:BXLT) is a $6 billion global biopharmaceutical leader developing, manufacturing and commercializing therapies for orphan diseases and underserved conditions in hematology, oncology and immunology. Driven by passion to make a meaningful impact on patients’ lives, Baxalta’s broad and diverse pipeline includes biologics with novel mechanisms and advanced technology platforms such as gene therapy. The Baxalta Global Innovation and R&D Center is located in Cambridge, Massachusetts. Launched in 2015 following separation from Baxter International, Baxalta’s heritage in biopharmaceuticals spans decades. Baxalta’s therapies are available in more than 100 countries and it has advanced biological manufacturing operations across 12 facilities, including state-of-the-art recombinant production and plasma fractionation. Headquartered in Northern Illinois, Baxalta employs 16,000 employees worldwide.
SOURCE: Baxalta
Post Views: 48
