Biogen will develop and commercialize Alkermes’ Phase III multiple sclerosis (MS) treatment ALKS 8700, the companies said today, through an up-to-$228 million-plus collaboration designed to neutralize a potential competitive challenge to Biogen’s MS blockbuster Tecfidera® (dimethyl fumarate).
ALKS 8700 is an oral, novel, and proprietary monomethyl fumarate (MMF) prodrug candidate in development for the treatment of relapsing forms of MS. According to Alkermes and Biogen, ALKS 8700 is designed to rapidly and efficiently convert to MMF in the body and to offer differentiated features as compared to the currently marketed Tecfidera.
“We aim to provide patients with a new oral therapy which may bring differentiated benefits,” Biogen CEO Michel Vounatsos said in a statement. “This partnership is further evidence of Biogen’s ongoing commitment to multiple sclerosis and builds upon our deep experience in neuroscience and particularly in MS.”
Tecfidera is Biogen’s best-selling drug, having generated $3.968 billion in revenue in 2016—missing GEN’s list of the Top 15 Best-Selling Drugs of 2016 with a ranking of 18th. Over the first nine months of 2017, Tecfidera racked up $3.139 billion, up 5.4% from January–September 2016.
Under the companies’ global license and collaboration agreement, Biogen agreed to reimburse Alkermes for half of this year’s development costs for ALKS 8700, by paying Alkermes $28 million upfront.
Biogen also agreed to take responsibility for all development expenses related to the MS candidate beginning January 1, 2018, and pay up to $200 million tied to achieving clinical and regulatory milestones. Biogen said it anticipates recording as an expense this year an initial milestone payment of $50 million.
Alkermes agreed to continue overseeing regulatory interactions with the FDA through the potential approval of the New Drug Application (NDA) for ALKS 8700 for the treatment of MS.
Biogen to Develop Alkermes’ MS Candidate ALKS 8700