Biogen has executed a deal to protect its main multiple sclerosis franchise Tecfidera from the risk of Alkermes’ ALKS 8700. The deal provides Biogen the exclusive worldwide rights to a candidate created to match the efficacy and enhance the safety of a foundation of its commercial operation.
Massachusetts-based Biogen is paying Alkermes $28 million upfront to cover 50% of what its new partner has spent on developing the drug in 2017. Alkermes is also due to receive the first $50 million of the up to $200 million in tranches connected to the deal before the end of this year. And it will free itself of the cost of developing ALKS 8700 in January when Biogen will take full responsibility for financing its future progress.
Alkermes will keep responsibility for engagements with the FDA through to the approval of the treatment. If everything goes well, Alkerme will collect mid-teen royalties on global sales of ALKS 8700.
The modest dollar amount connected to the deal indicates, there is some concern about how large of a piece they can collect off the multiple sclerosis market. ALKS 8700 is an oral drug of monomethyl fumarate. That grants access the asset to follow the FDA’s 505(b)(2) regulatory pathway referencing Tecfidera, the scientific name of which is called dimethyl fumarate.
Alkermes came up with the calculation in a bid to offer multiple sclerosis patients the efficacy and convenience of Biogen’s oral Tecfidera without the gastrointestinal side effects. The company hints late last month it could be on pace to deliver such a treatment when it posted data connecting ALKS 8700 to a 3.7% adverse event-related withdrawal rate in a study with 570 patients.
The study is part of two phase 3 trials that are being conducted by Alkermes. The other studies, which began this year, is doing a comparison to the gastrointestinal tolerability of ALKS 8700 and Tecfidera in approximately 420 patients who suffer from relapsing remitting multiple sclerosis.