Pfizer has entered into an agreement with Synthon to acquire exclusive commercialization rights to glatiramer acetate in the U.S. The drug is a potential generic version of Copaxone for the treatment of relapsing remitting multiple sclerosis.

Synthon has filed an ANDA with the FDA for a once daily 20mg/ml formulation of glatiramer acetate, and an ANDA for a three times a week 40mg/ml formulation of glatiramer acetate. The 40mg/ml filing may be eligible for 180 days of shared marketing exclusivity under the provisions of the Hatch-Waxman Act.

Pfizer will have exclusive rights to commercialize both dosage formulations in the U.S. Synthon is responsible for the clinical development, manufacture and supply of glatiramer acetate. Financial terms were not disclosed.

“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.”

“We are very pleased to partner with Pfizer on the introduction of glatiramer acetate to patients and healthcare providers in the U.S.,” said Jacques Lemmens, chief executive officer of Synthon. “Our partnership will ensure the rapid introduction of a high quality product through Pfizer’s well-established presence in the United States, which in turn may result in savings on an important MS medication for patients and payors.”