Advancement of M834 to clinical-stage development represents important milestone in the Momenta/Mylan biosimilar portfolio
CAMBRIDGE, MA, USA, HERTFORDSHIRE, UK and PITTSBURGH, PA, USA I November 02, 2016 I Momenta Pharmaceuticals, Inc. (Nasdaq:MNTA) and Mylan N.V. (NASDAQ:MYL) (TASE:MYL), today announced that dosing has begun in a Phase 1 study to compare the pharmacokinetics, safety and immunogenicity of M834, a proposed biosimilar of ORENCIA (abatacept), to US- and EU-sourced ORENCIA in normal healthy volunteers. Under the Momenta-Mylan collaboration agreement, Momenta has achieved the milestone necessary to earn a $25 million payment from Mylan.
“We are deeply committed to expanding treatment access and providing high-quality and affordable biosimilar options for patients who suffer from autoimmune and inflammatory diseases,” said Craig Wheeler, President and Chief Executive Officer of Momenta Pharmaceuticals. “Our collaboration with Mylan, one of the largest generics and specialty pharmaceutical companies in the world, positions us to advance this important biosimilar candidate through the clinic. We believe we have the opportunity to be the leader in offering patients a biosimilar version of ORENCIA.”
Mylan President Rajiv Malik commented, “Our pipeline of biosimilar products, which is one of the largest in development in the industry, continues to make exciting advancements and today’s milestone for M834 is yet another example of this progress. Our partnership with Momenta is based not only on a shared commitment to bringing more affordable versions of critical biologic products to patients around the world, but also on our mutual passion for science and R&D, and our willingness to invest in it. To date, Mylan has invested more than $1 billion in our biologics and insulin analog programs.”
The Phase 1 study is a randomized, double-blind, three-arm, parallel group, single-dose study that is expected to enroll approximately 300 healthy volunteers. The companies plan to report top-line data from this study by the end of 2017.
About M834, a proposed biosimilar of ORENCIA® (abatacept)
M834 is developed in collaboration by 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 the US and EU for the treatment of Juvenile Idiopathic Arthritis. In 2015, worldwide sales of ORENCIA totaled $1.9 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.
To receive additional information about Momenta, please visit the website at www.momentapharma.com, which does not form a part of this press release.
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 2,700 generic and branded pharmaceuticals, including antiretroviral therapies on which approximately 50% of people being treated for HIV/AIDS worldwide depend. We market our products in more than 165 countries and territories. Our global R&D and manufacturing platform includes more than 50 facilities, and we are one of the world’s largest producers of active pharmaceutical ingredients. Every member of our more than 40,000-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
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Advancement of M834 to clinical-stage development represents important milestone in the Momenta/Mylan biosimilar portfolio
CAMBRIDGE, MA, USA, HERTFORDSHIRE, UK and PITTSBURGH, PA, USA I November 02, 2016 I Momenta Pharmaceuticals, Inc. (Nasdaq:MNTA) and Mylan N.V. (NASDAQ:MYL) (TASE:MYL), today announced that dosing has begun in a Phase 1 study to compare the pharmacokinetics, safety and immunogenicity of M834, a proposed biosimilar of ORENCIA (abatacept), to US- and EU-sourced ORENCIA in normal healthy volunteers. Under the Momenta-Mylan collaboration agreement, Momenta has achieved the milestone necessary to earn a $25 million payment from Mylan.
“We are deeply committed to expanding treatment access and providing high-quality and affordable biosimilar options for patients who suffer from autoimmune and inflammatory diseases,” said Craig Wheeler, President and Chief Executive Officer of Momenta Pharmaceuticals. “Our collaboration with Mylan, one of the largest generics and specialty pharmaceutical companies in the world, positions us to advance this important biosimilar candidate through the clinic. We believe we have the opportunity to be the leader in offering patients a biosimilar version of ORENCIA.”
Mylan President Rajiv Malik commented, “Our pipeline of biosimilar products, which is one of the largest in development in the industry, continues to make exciting advancements and today’s milestone for M834 is yet another example of this progress. Our partnership with Momenta is based not only on a shared commitment to bringing more affordable versions of critical biologic products to patients around the world, but also on our mutual passion for science and R&D, and our willingness to invest in it. To date, Mylan has invested more than $1 billion in our biologics and insulin analog programs.”
The Phase 1 study is a randomized, double-blind, three-arm, parallel group, single-dose study that is expected to enroll approximately 300 healthy volunteers. The companies plan to report top-line data from this study by the end of 2017.
About M834, a proposed biosimilar of ORENCIA® (abatacept)
M834 is developed in collaboration by 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 the US and EU for the treatment of Juvenile Idiopathic Arthritis. In 2015, worldwide sales of ORENCIA totaled $1.9 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.
To receive additional information about Momenta, please visit the website at www.momentapharma.com, which does not form a part of this press release.
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 2,700 generic and branded pharmaceuticals, including antiretroviral therapies on which approximately 50% of people being treated for HIV/AIDS worldwide depend. We market our products in more than 165 countries and territories. Our global R&D and manufacturing platform includes more than 50 facilities, and we are one of the world’s largest producers of active pharmaceutical ingredients. Every member of our more than 40,000-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: 47
