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news.Pfizer has entered into an agreement to acquire the exclusive US commercialization rights of Synthon's glatiramer acetate, a potential generic version of Teva's Copaxone, indicated to treat relapsing remitting multiple sclerosis (RRMS).
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In November 2011, Synthon filed an abbreviated new drug application (ANDA) with the US Food and Drug Administration (FDA) for a once daily 20mg/ml formulation of glatiramer acetate, while last year the company also filed an ANDA for a three times a week 40mg/ml formulation of glatiramer acetate with the FDA.
Currently, glatiramer acetate is being reviewed by the FDA for the treatment of patients with RRMS.
Additionally, 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.
Pfizer Global Established Pharma business North America regional president Diem Nguyen said: "Neurologic diseases such as multiple sclerosis represent some of the most debilitating illnesses of our time.
"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 US."
As part of the deal, Pfizer will have exclusive rights to commercialize both dosage formulations of glatiramer acetate in the US, while Synthon will be responsible for clinical development, manufacture and supply of the product.
In the US, Pfizer is solely responsible for the commercialization of glatiramer acetate.