BANNOCKBURN, IL and CAMBRIDGE, MA, USA I December 21, 2015 I Baxalta Incorporated (NYSE:BXLT) and Momenta Pharmaceuticals, Inc. (Nasdaq:MNTA), today announced that M923 met the primary endpoint in a randomized, double-blind, three-arm, parallel group, single-dose study. The primary objective of the study was to evaluate the pharmacokinetics of M923 compared to both U.S. and EU sourced HUMIRA® reference products.
“We are encouraged by the results of this study,” said John Orloff, M.D., head of Research & Development and chief scientific officer, Baxalta. “We are committed to expanding treatment access and providing additional options for patients who suffer from chronic inflammatory diseases. We look forward to bringing a biosimilar version of adalimumab to patients around the world.”
In addition to showing bioequivalence in pharmacokinetics, this study also evaluated safety, tolerability and immunogenicity following single doses of M923 given by injection. The safety profile and immunogenicity were also found to be comparable. A total of 324 healthy volunteers were enrolled in the study.
“The results of this PK study further validate our ability to develop high-quality biosimilar candidates using our complex systems analysis platform,” said Jim Roach, M.D., Senior Vice President of Development and Chief Medical Officer of Momenta Pharmaceuticals. “We are pleased with the results seen to date and expect that the data we generate from our ongoing pivotal trial in patients with chronic plaque psoriasis will continue to support the demonstration of biosimilarity of M923 to branded HUMIRA.”
This milestone is part of a global collaboration between Baxalta and Momenta to develop and commercialize M923. With this collaboration, Baxalta leverages its leading clinical development and biologic manufacturing expertise, and global commercial capabilities, while Momenta provides its expertise in high-resolution analytics, characterization, clinical and regulatory strategy for complex products, and product and process development.
Baxalta and Momenta announced the initiation of a separate pivotal clinical trial of M923 in chronic plaque psoriasis in October 2015. The companies are targeting a first regulatory submission in 2017 and a first commercial launch as early as 2018.
About M923, a proposed biosimilar of HUMIRA® (adalimumab)
M923 is developed in collaboration by Baxalta Incorporated and Momenta Pharmaceuticals. HUMIRA, the largest selling therapeutic on the market today, is a significant intervention for patients with autoimmune/inflammatory diseases. Adalimumab is used to treat many such conditions including rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis and plaque psoriasis.
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.
About Momenta
Momenta Pharmaceuticals is a biotechnology company specializing in the detailed structural analysis of complex drugs and is headquartered in Cambridge, MA. Momenta is applying its technology to the development of generic versions of complex drugs, biosimilar and potentially interchangeable biologics, and to the discovery and development of novel therapeutics for oncology and autoimmune indications.
SOURCE: Baxalta
Post Views: 243
BANNOCKBURN, IL and CAMBRIDGE, MA, USA I December 21, 2015 I Baxalta Incorporated (NYSE:BXLT) and Momenta Pharmaceuticals, Inc. (Nasdaq:MNTA), today announced that M923 met the primary endpoint in a randomized, double-blind, three-arm, parallel group, single-dose study. The primary objective of the study was to evaluate the pharmacokinetics of M923 compared to both U.S. and EU sourced HUMIRA® reference products.
“We are encouraged by the results of this study,” said John Orloff, M.D., head of Research & Development and chief scientific officer, Baxalta. “We are committed to expanding treatment access and providing additional options for patients who suffer from chronic inflammatory diseases. We look forward to bringing a biosimilar version of adalimumab to patients around the world.”
In addition to showing bioequivalence in pharmacokinetics, this study also evaluated safety, tolerability and immunogenicity following single doses of M923 given by injection. The safety profile and immunogenicity were also found to be comparable. A total of 324 healthy volunteers were enrolled in the study.
“The results of this PK study further validate our ability to develop high-quality biosimilar candidates using our complex systems analysis platform,” said Jim Roach, M.D., Senior Vice President of Development and Chief Medical Officer of Momenta Pharmaceuticals. “We are pleased with the results seen to date and expect that the data we generate from our ongoing pivotal trial in patients with chronic plaque psoriasis will continue to support the demonstration of biosimilarity of M923 to branded HUMIRA.”
This milestone is part of a global collaboration between Baxalta and Momenta to develop and commercialize M923. With this collaboration, Baxalta leverages its leading clinical development and biologic manufacturing expertise, and global commercial capabilities, while Momenta provides its expertise in high-resolution analytics, characterization, clinical and regulatory strategy for complex products, and product and process development.
Baxalta and Momenta announced the initiation of a separate pivotal clinical trial of M923 in chronic plaque psoriasis in October 2015. The companies are targeting a first regulatory submission in 2017 and a first commercial launch as early as 2018.
About M923, a proposed biosimilar of HUMIRA® (adalimumab)
M923 is developed in collaboration by Baxalta Incorporated and Momenta Pharmaceuticals. HUMIRA, the largest selling therapeutic on the market today, is a significant intervention for patients with autoimmune/inflammatory diseases. Adalimumab is used to treat many such conditions including rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis and plaque psoriasis.
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.
About Momenta
Momenta Pharmaceuticals is a biotechnology company specializing in the detailed structural analysis of complex drugs and is headquartered in Cambridge, MA. Momenta is applying its technology to the development of generic versions of complex drugs, biosimilar and potentially interchangeable biologics, and to the discovery and development of novel therapeutics for oncology and autoimmune indications.
SOURCE: Baxalta
Post Views: 243
