Pharmaceutical giant Pfizer has acquired from Synthon the exclusive commercialization rights in the US to glatiramer acetate, a potential generic version of multiple sclerosis treatment, the flagship branded drug of Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA; TASE: TEVA).
This development comes as Teva grapples with Sandoz's 20 mg/mL generic daily version of Copaxone - Glatopa - which was launched on June 18. Despite that competition, Teva reported record second quarter global sales of Copaxone (20 mg/mL and 40 mg/mL) amounting to $1.1 billion, up 12% compared with the second quarter of 2014, including $870 million sales in the US.
But while Teva believes its improved 40 mg/mL three times a week version of Copaxone is patented protected until 2013, Synthon (and now Pfizer) have other ideas.
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 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 US. 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.
Published by Globes [online], Israel business news - www.globes-online.com - on August 3, 2015
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