The US multiple sclerosis market is expected to evolve notably in 2014, with analysts now confident that the FDA will approve at least one generic version of Teva´s Copaxone when exclusivity expiries in May.
From a commercial perspective, Teva will seek to defend loss of share to generic competition via the launch of a more convenient version of Copaxone, which is dosed three times a week rather than once-daily.
FDA approval for this formulation was secured last week and Teva plans an immediate launch which will be supported by modest list price discounting versus the existing Copaxone brand (reported to be between 2 percent and 8 percent by various sources)
Last month, Teva´s chief science officer Michael Hayden said that the company expects to switch around 45 percent of existing Copaxone patients onto the longer-acting formulation (including an aggressive 35 percent switch by June), in order to preserve some patient base prior to the potential launch of generic competition.
The company has become increasingly confident in its ability to convert patients, noted analysts at Bloomberg Industries last week; in late 2012, for example, Teva was suggesting that it could switch around a third of patients to the newer formulation.
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