The patent play: Biogen gets a PhIII boost for its bit-better take on the blockbuster MS franchise drug Tecfidera
Biogen $BIIB got some modestly upbeat news from the R&D group today on a successor drug to Tecfidera, their big multiple sclerosis franchise therapy.
With the help of their collaborator Alkermes $ALKS, which specializes in me-better drugs (with mixed results), the partners posted a fresh set of Phase III data showing that their drug Vumerity — diroximel fumarate — came in with a markedly improved tolerability profile compared with their franchise drug.
The key numbers: Only 0.8% of patients in the diroximel fumarate arm dropped out due to GI effects compared to 4.8% in the Tecfidera arm. The overall dropout rate was 1.6% for diroximel fumarate and 6.0% for dimethyl fumarate.
This isn’t exactly a breakthrough in the MS field, which has seen a number of new drugs enter to roil the market — with more on the way. As the partners have explained, the drug is designed to rapidly convert to monomethyl fumarate. Biogen is steering this to a Q4 PDUFA date with the FDA using the 505(b)(2) regulatory pathway for therapies that lie somewhere in the gray zone between new chemical entities and generics. That means they can reference the Tecfidera data in their application, which is likely to keep the odds of an approval high.
In addition to helping patients avoid a switch to another drug or an interruption in treatment, which would raise the risk of a relapse, the big play here is on the patent side. Here’s SVB Leerink’s Geoffrey Porges take from a few months ago:
Vumerity has a PDUFA date in Q4 2019, and it has a stronger (compared to the ‘514 patent) composition-of-matter patent (for Tecfidera) 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.
SVB Leerink’s Marc Goodman offered this assessment today:
We believe Vumerity could be a notable product in the multiple sclerosis market as a second-generation Tecfidera with a differentiated GI profile. Our models include >$1B peak sales, and we are not making any changes at this time. Given Tecfidera’s sales (Biogen reported $870M in US sales in just 2Q19), this product could clearly be larger; however, we need more visibility on Biogen’s strategy and Tecfidera’s IP situation to get more positive.
Credit Suisse’s Evan Seigerman, though, is being much more conservative.
The lack of prescriber awareness and the intensifying competition in the oral space (from novel S1Ps and expected generics to Aubagio and Gilenya) lead us to take a conservative view of Vumerity’s commercial potential (we forecast >$400M in sales by 2024).
Social image: Biogen, AP Images