Date: 2015-08-03
Type of information: Commercialisation agreement
Compound: glatiramer acetate
Company: Pfizer (USA - NY) Synthon (The Netherlands)
Therapeutic area: Neurodegenerative diseases
Type agreement: commercialisation
Action mechanism: peptide. Glatiramer acetate is a mixture of synthetic polypeptides composed of four amino acids resembling the myelin basic protein. In November 2011, Synthon filed an Abbreviated New Drug Application (ANDA) with the 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.
Disease: relapsing remitting multiple sclerosis
Details: * On August 3, 2015, Pfizer and Synthon, an international pharmaceutical company specializing in the development of complex generic medicines, 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 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. 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. A Phase III Glatiramer Acetate clinical trial To assess Equivalence with Copaxone® (GATE) was set up following Scientific Advice received from the European Medicines Agency (EMA) with the aim to show equivalence of Synthon’s glatiramer acetate (Synthon GTR) with Teva’s Copaxone® in a well-controlled 3-arm double-blind equivalence study. The open-label part of the study further aimed to provide 2-year efficacy, safety and tolerability data on Synthon’s generic glatiramer acetate and to show safety of switching from Copaxone® to Synthon’s generic. The large-scale, multicenter study consisted of a nine-month double-blind efficacy comparison followed by a 15-month open-label extension and was executed in RRMS patients in Europe (including Russia, Ukraine and Belarus), Mexico, South Africa and the United States.
Financial terms:
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