Synthon’s glatiramer acetate, a potential generic version of Copaxone®1 for the treatment of relapsing remitting multiple sclerosis is currently being reviewed by the U.S. Food and Drug Administration
NEW YORK & NIJMEGEN, Netherlands--(BUSINESS WIRE)--Pfizer Inc. and Synthon, an international pharmaceutical company specializing in the development of complex generic medicines, today announced they have entered into an agreement whereby Pfizer has acquired the exclusive commercialization rights in the United States to glatiramer acetate, a potential generic version of the originator medicine Copaxone® for the treatment of relapsing remitting multiple sclerosis (RRMS).
In November 2011, Synthon filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) for a once daily 20mg/ml formulation of glatiramer acetate. In early 2014, Synthon filed an ANDA for a three times a week 40mg/ml formulation of glatiramer acetate with the FDA. In addition, Synthon believes its glatiramer acetate 40mg/ml filing may be eligible for 180 days of shared marketing exclusivity under the provisions of the Hatch-Waxman Act.
“Neurologic diseases such as multiple sclerosis represent some of the most debilitating illnesses of our time,” said Diem Nguyen, regional president of North America, Pfizer Global Established Pharma business. “Pfizer’s significant experience in successfully bringing meaningful medicines to market together with Synthon’s scientific expertise in neurodegenerative diseases will enable us to leverage our core capabilities in support of improving patient health in the United States.”
Under the terms of the agreement, Pfizer will have exclusive rights to commercialize both dosage formulations of Synthon’s glatiramer acetate in the United States. Synthon is responsible for the clinical development, manufacture and supply of glatiramer acetate. Pfizer is solely responsible for the commercialization of glatiramer acetate in the United States. Financial terms of the agreement were not disclosed.
Keep CURRENT with MS Views and News - OPT-IN here