Biogen has struck a deal to protect its blockbuster multiple sclerosis franchise Tecfidera from the threat of Alkermes’ ALKS 8700. The deal gives Biogen the exclusive worldwide rights to a candidate designed to match the efficacy and better the safety of a cornerstone of its commercial operation.
Cambridge, Massachusetts-based Biogen is paying Alkermes $28 million upfront to cover half of what its new partner has spent on developing the drug this year. Alkermes is also set to receive the first $50 million of the up to $200 million in milestones tied to the deal before the end of 2017. And it will free itself of the cost of developing ALKS 8700 in January, when Biogen will take full responsibility for funding its progress.
Alkermes will retain responsibility for interactions with the FDA through to the approval of the drug. If all goes according to plan, Alkermes will pocket mid-teen royalties on worldwide sales of ALKS 8700.
As the relatively modest dollar figures attached to the deal suggest, there is some doubt about how big a piece of the multiple sclerosis market ALKS 8700 can seize. ALKS 8700 is an oral prodrug of monomethyl fumarate. That allows the asset to follow the FDA’s 505(b)(2) regulatory pathway referencing Tecfidera, the scientific name of which is dimethyl fumarate.
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Alkermes came up with the formulation in a bid to offer multiple sclerosis patients the efficacy and convenience of Biogen’s oral Tecfidera without the gastrointestinal side effects. The biotech suggested late last month it may be on track to deliver such a drug when it posted data linking ALKS 8700 to a 3.7% adverse event-related dropout rate in a 570-patient study.
The study is one of two phase 3 trials being run by Alkermes. The other study, which got underway this year, is comparing the gastrointestinal tolerability of ALKS 8700 and Tecfidera in 420 patients with relapsing remitting multiple sclerosis.
Data from that trial will dictate how big of a threat ALKS 8700 poses to Tecfidera. Biogen will sleep easier in the run-up to the readout knowing it has already mitigated the risk.