Alkermes closing in on Biogen with MS rival

Alkermes aims to win a slice of the multiple sclerosis market with a drug to rival Biogen’s big-selling Tecfidera, but less likely to produce unpleasant gastrointestinal side effects.

The phenomenon nicknamed “Tecfidera tummy” is a major problem for Biogen, which has even introduced coaching programmes to encourage patients to stay on the drug and see the benefits of longer-term treatment once the side effects have subsided.

With sales of $845 million in Q3 alone, Biogen is heavily reliant on Tecfidera, but has seen revenue growth slow thanks to competition from rival oral drugs, Novartis' Gilenya and Sanofi's Aubagio.

Now Dublin-headquartered biotech Alkermes is aiming to capture a share of the MS market with a next-generation rival. Its drug works along the same pathway, but does not produce the side effects associated with Tecfidera (dimethyl fumarate).

Alkermes' chief executive Richard Pops told the Jefferies London Healthcare Conference that its ALKS 8700 is a prodrug that metabolises into monomethyl fumarate (MMF), the breakdown product of Tecfidera that produces its clinical effect.

Pops said ALKS 8700 could be ready to file with the FDA in 2018 under an accelerated approval, granted by the regulator due to the drug’s potential advantage over Tecfidera.

He said: “We are good at making prodrugs. We have created a new molecule that could compete really well [with Tecfidera].”

The company already has data showing ALKS 8700 produces almost identical amounts of MMF as Tecfidera, meaning that the FDA will not require as much efficacy data as usual.

This leaves a safety study, along with the “pharmacokinetic bridge” data showing how the drug breaks into MMF, to get the drug approved in the US.

Alkermes is also conducting a head-to-head GI study to confirm that the drug has a better gastrointestinal side-effect profile compared with Tecfidera.

He said: “We want to make sure with a head to head study in 400 patients.”