NEW YORK — Pfizer Inc. has entered into an agreement with Synthon to acquire the exclusive U.S. commercialization rights for glatiramer acetate, a potential generic version of Teva Pharmaceuticals’ Copaxone for the treatment of relapsing remitting multiple sclerosis (RRMS).
Pfizer said Monday that under the agreement, it 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. Financial terms of the deal weren’t disclosed.
Synthon’s drug is still under review by the Food and Drug Administration. In November 2011, Synthon filed an Abbreviated New Drug Application (ANDA) with the FDA for a once-daily 20 mg/ml formulation of glatiramer acetate. Then in early 2014, Synthon filed an ANDA for a three-times-per-week 40 mg/ml formulation of glatiramer acetate with the FDA.
In addition, Synthon said its glatiramer acetate 40 mg/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,” stated Diem Nguyen, regional president of North America for 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.”
RRMS, the most common form of MS, is characterized by clear episodes of inflammatory activity known as relapses, followed by remission. RRMS affects about 85% of newly diagnosed patients. According to the National Multiple Sclerosis Society, MS affects more than 2.3 million people worldwide, including an estimated 400,000 in the United States.
“We are very pleased to partner with Pfizer on the introduction of glatiramer acetate to patients and health care providers in the United States,” commented Jacques Lemmens, chief executive officer of Synthon, based in Nijmegen, the Netherlands. “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.”
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