CAMBRIDGE, MA, USA and HERTFORDSHIRE, UK and PITTSBURGH, MD, USA I November 01, 2017 I Momenta Pharmaceuticals, Inc. (Nasdaq:MNTA) and Mylan N.V. (NASDAQ:MYL) (TASE:MYL), today announced that M834, a proposed biosimilar of ORENCIA (abatacept), did not meet its primary pharmacokinetic (PK) endpoints in the Phase 1 study to compare the pharmacokinetics, safety and immunogenicity of M834 to US- and EU-sourced ORENCIA in normal healthy volunteers. Momenta and Mylan continue to gather and analyze these data to inform next steps for the program.
“This was an unexpected result and we are disappointed with the outcome of this PK study,” said Craig Wheeler, President and Chief Executive Officer of Momenta Pharmaceuticals. “We are in the process of gathering the full data set and will work with Mylan to fully analyze these data to better understand the study results and evaluate next steps for this program. We remain committed to executing on our biosimilar portfolio.”
The Phase 1 study was a randomized, double-blind, three-arm, parallel group, single-dose subcutaneous administration clinical study to compare the pharmacokinetics, safety, and immunogenicity of M834, US-sourced ORENCIA, and EU-sourced ORENCIA in 243 normal healthy volunteers.
About M834, a proposed biosimilar of ORENCIA® (abatacept)
M834 is part of the collaboration between Mylan N.V. and Momenta Pharmaceuticals. ORENCIA is a fusion protein and the only CTLA-4Ig approved in the US, EU, and Japan for the treatment of Rheumatoid Arthritis and in the US and EU for the treatment of Psoriatic Arthritis and Juvenile Idiopathic Arthritis. In 2016, worldwide sales of ORENCIA totaled $2.4 billion.
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 autoimmune indications.
About Mylan
Mylan is a global pharmaceutical company committed to setting new standards in healthcare. Working together around the world to provide 7 billion people access to high quality medicine, we innovate to satisfy unmet needs; make reliability and service excellence a habit; do what’s right, not what’s easy; and impact the future through passionate global leadership. We offer a growing portfolio of more than 7,500 marketed products around the world, including antiretroviral therapies on which approximately 50% of people being treated for HIV/AIDS in the developing world depend. We market our products in more than 165 countries and territories. We are one of the world’s largest producers of active pharmaceutical ingredients. Every member of our more than 35,000-strong workforce is dedicated to creating better health for a better world, one person at a time. Learn more at Mylan.com.
SOURCE: Momenta Pharmaceuticals
Post Views: 22
CAMBRIDGE, MA, USA and HERTFORDSHIRE, UK and PITTSBURGH, MD, USA I November 01, 2017 I Momenta Pharmaceuticals, Inc. (Nasdaq:MNTA) and Mylan N.V. (NASDAQ:MYL) (TASE:MYL), today announced that M834, a proposed biosimilar of ORENCIA (abatacept), did not meet its primary pharmacokinetic (PK) endpoints in the Phase 1 study to compare the pharmacokinetics, safety and immunogenicity of M834 to US- and EU-sourced ORENCIA in normal healthy volunteers. Momenta and Mylan continue to gather and analyze these data to inform next steps for the program.
“This was an unexpected result and we are disappointed with the outcome of this PK study,” said Craig Wheeler, President and Chief Executive Officer of Momenta Pharmaceuticals. “We are in the process of gathering the full data set and will work with Mylan to fully analyze these data to better understand the study results and evaluate next steps for this program. We remain committed to executing on our biosimilar portfolio.”
The Phase 1 study was a randomized, double-blind, three-arm, parallel group, single-dose subcutaneous administration clinical study to compare the pharmacokinetics, safety, and immunogenicity of M834, US-sourced ORENCIA, and EU-sourced ORENCIA in 243 normal healthy volunteers.
About M834, a proposed biosimilar of ORENCIA® (abatacept)
M834 is part of the collaboration between Mylan N.V. and Momenta Pharmaceuticals. ORENCIA is a fusion protein and the only CTLA-4Ig approved in the US, EU, and Japan for the treatment of Rheumatoid Arthritis and in the US and EU for the treatment of Psoriatic Arthritis and Juvenile Idiopathic Arthritis. In 2016, worldwide sales of ORENCIA totaled $2.4 billion.
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 autoimmune indications.
About Mylan
Mylan is a global pharmaceutical company committed to setting new standards in healthcare. Working together around the world to provide 7 billion people access to high quality medicine, we innovate to satisfy unmet needs; make reliability and service excellence a habit; do what’s right, not what’s easy; and impact the future through passionate global leadership. We offer a growing portfolio of more than 7,500 marketed products around the world, including antiretroviral therapies on which approximately 50% of people being treated for HIV/AIDS in the developing world depend. We market our products in more than 165 countries and territories. We are one of the world’s largest producers of active pharmaceutical ingredients. Every member of our more than 35,000-strong workforce is dedicated to creating better health for a better world, one person at a time. Learn more at Mylan.com.
SOURCE: Momenta Pharmaceuticals
Post Views: 22
