CAMBRIDGE, MA, USA I August 28, 2014 I Momenta Pharmaceuticals (Nasdaq:MNTA) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Abbreviated New Drug Application (ANDA) for a three-times-a-week generic COPAXONE® (glatiramer acetate injection, 40 mg/mL), submitted by Sandoz Inc., Momenta’s development and commercialization partner for this product candidate.
Based on publicly-available information, Momenta believes that, should the ANDA be approved, it would be eligible for 180-day first-to-file exclusivity under Hatch-Waxman. The product could be on the market as early as the first quarter of 2017, assuming the Paragraph IV challenge is successful and adheres to customary Hatch-Waxman litigation timelines. Since the 40 mg/mL formulation contains the same drug substance as the 20 mg/mL ANDA currently under review by the FDA, Momenta anticipates the FDA review process can be completed within the same time frame.
“We are pleased to announce the acceptance of the ANDA for our three-times-a-week generic Copaxone for review by the FDA,” said Craig A. Wheeler, President and Chief Executive Officer of Momenta Pharmaceuticals. “This formulation will allow for a more affordable, three-times-a-week dosing regimen for patients with relapsing-forms of multiple sclerosis.”
About Relapsing-Remitting Multiple Sclerosis (RRMS)
Multiple sclerosis is a devastating chronic disease of the central nervous system characterized by inflammation and neurodegeneration. RRMS, defined by inflammatory attacks on the protective coating of neurons (myelin) and characterized by intermittent bouts of symptoms, is the most common disease course at the time of diagnosis. Copaxone is among the leading products marketed for treatment of RRMS. It works by stopping the body from damaging its own nerve cells (myelin). In North America, Copaxone is marketed by Teva Neuroscience, Inc., which is a subsidiary of Teva.
About Momenta
Momenta Pharmaceuticals is a biotechnology company specializing in the detailed structural analysis of complex mixture 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 products.
SOURCE: Momenta Pharmaceuticals
Post Views: 212
CAMBRIDGE, MA, USA I August 28, 2014 I Momenta Pharmaceuticals (Nasdaq:MNTA) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Abbreviated New Drug Application (ANDA) for a three-times-a-week generic COPAXONE® (glatiramer acetate injection, 40 mg/mL), submitted by Sandoz Inc., Momenta’s development and commercialization partner for this product candidate.
Based on publicly-available information, Momenta believes that, should the ANDA be approved, it would be eligible for 180-day first-to-file exclusivity under Hatch-Waxman. The product could be on the market as early as the first quarter of 2017, assuming the Paragraph IV challenge is successful and adheres to customary Hatch-Waxman litigation timelines. Since the 40 mg/mL formulation contains the same drug substance as the 20 mg/mL ANDA currently under review by the FDA, Momenta anticipates the FDA review process can be completed within the same time frame.
“We are pleased to announce the acceptance of the ANDA for our three-times-a-week generic Copaxone for review by the FDA,” said Craig A. Wheeler, President and Chief Executive Officer of Momenta Pharmaceuticals. “This formulation will allow for a more affordable, three-times-a-week dosing regimen for patients with relapsing-forms of multiple sclerosis.”
About Relapsing-Remitting Multiple Sclerosis (RRMS)
Multiple sclerosis is a devastating chronic disease of the central nervous system characterized by inflammation and neurodegeneration. RRMS, defined by inflammatory attacks on the protective coating of neurons (myelin) and characterized by intermittent bouts of symptoms, is the most common disease course at the time of diagnosis. Copaxone is among the leading products marketed for treatment of RRMS. It works by stopping the body from damaging its own nerve cells (myelin). In North America, Copaxone is marketed by Teva Neuroscience, Inc., which is a subsidiary of Teva.
About Momenta
Momenta Pharmaceuticals is a biotechnology company specializing in the detailed structural analysis of complex mixture 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 products.
SOURCE: Momenta Pharmaceuticals
Post Views: 212
