Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA; TASE: TEVA) flagship branded drug Copaxone for the treatment of multiple sclerosis could be about to face competition in Europe. Synthon today announced that it has successfully concluded the decentralized procedures for 20 milligram glatiramer acetate, a therapeutically equivalent version of the originator medicine Copaxone and that all 29 member states included in the decentralized procedures supported approval of the product.
However, it is unclear from Synthon's announcement when it will be permitted to market the treatment. Teva has always claimed that the European authorities have upheld that Copaxone's European patent is valid until 2025. But the patent relates to manufacturing rather than an equivalent molecule so it may be possible for Synthon to bypass the patent in their manufacturing process.
Copaxone already faces generic competition in the US from sandoz and Momentum for its 20 milligram dosage. But unlike those companies, Sunthon has conducted clinical trials that equate its treatment with Teva's branded drug.
Copaxone sales totaled $4 billion in 2015, of which NIS 3.2 billion was in the US, 5% down from 2014 when there was no generic competition.
Synthon’s chief executive officer Jacques Lemmens said: “This approval is testimony to the quality and similarity of our glatiramer acetate, which is the only clinically validated alternative to Copaxone in Europe. It is a landmark for Synthon and for MS patients throughout Europe, who are in anticipation of a more affordable treatment for this chronic, unpredictable, and debilitating disease.”
Published by Globes [online], Israel business news - www.globes-online.com - on April 12, 2016
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