Physician Views: Assessing recent commercial dynamics in the multiple sclerosis market
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 Teva's 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 last…the 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 Teva's 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 Teva's 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 Teva's business development strategy, with Mylan rejecting Teva's $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 Teva's opening bid.
Copaxone's robustness in the market is particularly impressive given that some key opinion leaders had pinpointed Teva's product as losing disproportionate market share to the new generation of oral therapies and Biogen's 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…