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A handful of events over the past week point to a potential shift in dynamics within the multiple sclerosis market, which could have notable implications for a number of leading players.
Most significantly, the FDA has approved the first generic version of Tevas Copaxone, which has been developed via a collaboration between Novartis Sandoz division and Momenta Pharmaceuticals. The AB-rated generic, which will be sold under the brand name Glatopa and is likely to be launched in September, provides a conclusion of sorts to long-running efforts to get a generic version of Copaxone over the regulatory line (The Q&A - At long lastthe FDA approves generic Copaxone - the key questions).
That said, approval of multiple generic versions will likely be necessary to shape a significant impact in terms of payer pressure, despite continued price increases in the MS space, one senior pharmacy benefit manager (PBM) executive told FirstWord. Furthermore, the long-awaited approval of a generic Copaxone product may do more to showcase the effectiveness of Tevas strategy to switch patients from the original 20mg, once-daily version to a more convenient 40mg version, which is dosed three times a week. Having converted around two-thirds of existing patients over the past year, this strategy has worked more effectively than most (outside Teva) expected.
Such is the convenience impact afforded by the 40mg version (in addition to a discount versus the 20mg formulation), even payers are unlikely to force a switch to a cheaper version without pricing dictated by multi-source generics, the PBM executive argued. Even if generic pricing is reduced by subsequent generic entrants, the stickiness of Tevas switch strategy could see attention among developers quickly shift to generic copies of the 40mg version, which analysts argue could reach the market from 2017 onwards (dependent on intellectual property).
The implications from this stem to Tevas business development strategy, with Mylan rejecting Tevas $40.1 billion acquisition offer on April 27 partly on the basis of it including "low-quality, high-risk Teva stock." A concern tied to the risk of generic erosion to 40mg Copaxone that Bernstein analyst Ronny Gal had previously told FirstWord would likely derail Tevas opening bid.
Copaxones robustness in the market is particularly impressive given that some key opinion leaders had pinpointed Tevas product as losing disproportionate market share to the new generation of oral therapies and Biogens Tecfidera in particular. The shoe, to some extent at least, currently appears to be on the other foot, with Biogen reporting a notable miss in Tecfidera Q1 revenues last week and citing multiple factors as contributing to this performance, including an FDA label changeto warn about a case of associated fatal progressive multifocal leukoencephalopathy (PML) in November.
Baird analyst Christopher Raymond thinks that performance of the two franchises is interlinked, with continued uptake of 40mg Copaxone a contributory factor to weaker than expected sales for Tecfidera. Analysts at Citi suggest that with generic Copaxone unlikely to launch before September at the earliest, Teva could intensify its efforts to drive conversion and broader uptake of the 40mg version over the next 6 months.
To better assess these latest developments in the multiple sclerosis market, FirstWord is polling US and EU5-based neurologists with the following questions
- Have you become aware of more hesitant sentiment towards the use of Tecfidera on safety grounds during the past year?
- If your usage of Tecfidera has stopped increasing/declined in recent months what is the primary cause?
- Taking clinical and competitive factors into account, if a potential patient has not been prescribed Tecfidera during the past 12 months what product are they most likely to receive instead?
- On clinical/convenience grounds, how comfortable would you be switching a patient from three times weekly branded Copaxone (40mg) to generic once-daily Copaxone (20mg)?
- On clinical/convenience grounds, how comfortable would you be switching a patient from three times weekly branded Copaxone (40mg) to generic three times weekly Copaxone (40mg)?
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