Pfizer, Synthon Form Pact for Generic Version of Teva’s Copaxone
Pfizer Inc. and Synthon, a pharmaceutical company specializing in developing complex generic medicines have formed an agreement whereby Pfizer has acquired the exclusive commercialization rights in the United States to glatiramer acetate, a potential generic version of Teva Pharmaceutical Industries’ Copaxone for treating relapsing remitting multiple sclerosis.
Under 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.
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. In early 2014, Synthon filed an ANDA for a three times a week 40 mg/ml formulation of glatiramer acetate with the FDA. In addition, Synthon believes 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.
Copaxone is Teva’s top-selling drug with 2014 revenues of $4.3 billion. The US Orange Book patents covering Copaxone (20 mg) expired in May 2014. To combat generic-drug incursion for Copaxone, Teva developed a new formulation, Copaxone 40 mg/mL, which is administered three times a week. The new formulation, which was approved by the FDA in January 2014, allows for a less frequent dosing regimen administered subcutaneously for patients with relapsing forms of MS.
In April 2015, Sandoz, a Novartis company, received FDA approval for Glatopa, a generic version of Teva’s Copaxone (glatiramer acetate injection) 20 mg/mL, making it the first generic version of Copaxone approved by the FDA.