Troubled Biogen shows off its me-better approach to MS on PhIII update — but is it really just a patent play?
Researchers at the troubled Biogen are touting the latest safety update on a Phase III MS drug now under review at the FDA. Designed as a milder drug than its MS star Tecfidera, the company reported that there was a discontinuation rate of 0.7% over one year of treatment using diroximel fumarate, an oral therapy which they believe will help position this on the market in 2020.
Biogen partnered with Alkermes to get this drug, which is unlikely to do a whole lot in terms of reforming the big biotech’s tarnished R&D rep after the late-stage failure of aducanumab. Alkermes — which has had plenty of its own R&D problems with the me-better approach — dubbed this one ALKS 8700, which they plan to sell as Vumerity.
For analysts, this drug is more about protecting a key franchise rather than doing anything truly innovative for patients. In a recent note, SVB Leerink’s Geoffrey Porges observed:
Biogen’s management discussed their belief in the strength of Tecfidera’s ‘514 patent that provides market exclusivity in the US until 2028. This patent has been extensively reviewed by the USPTO, and has stood up to a prior IPR and prior interference challenge. That said, the patent is subject to new, ongoing IPR and District Court legal challenges, and management stated they were “preparing for all possible outcomes.” This will include launching the follow-on asset Vumerity (diroximel fumarate) and shifting patients to the product. Vumerity has a PDUFA date in Q4 2019, and it has a stronger (compared to the ‘514 patent) composition-of-matter patent that extends to 2033. This approval will occur before the decision for any Tecfidera legal challenge, and it now appears Biogen will enact a commercial push to capture new and switch patients on Vumerity in early 2020, at least to establish an alternative commercial strategy if Tecfidera goes generic earlier than anticipated.
Tecfidera was introduced with great acclaim back in the early days of George Scangos’ reign at Biogen. But the franchise has been feeling the heat from rivals that have been coming along. This new drug is unlikely to blunt any impact on that side of the equation.
The partners are also studying the safety profile of diroximel fumarate compared to dimethyl fumarate (Tecfidera) in the ongoing EVOLVE-MS-2 study, with results expected later this year. The PDUFA date is sometime in Q4.