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.

505(b)(2) Regulatory Pathway

Alkermes plans to seek approval of ALKS 8700 by referencing Tecfidera under the 505(b)(2) regulatory pathway, through which the FDA can approve an NDA for which one or more of the clinical studies relied upon by the applicant for approval “were not conducted by or for the applicant and for which the applicant has not obtained a right of reference or use from the person by or for whom the investigations were conducted.”

Biogen and Alkermes said the registration package being prepared for ALKS 8700 will include pharmacokinetic bridging studies that establish bioequivalence to Tecfidera, as well as data from a two-year, 580-patient safety study known as Endeavoring to Advance Treatment for Patients Living with Multiple Sclerosis 1 (EVOLVE-MS-1)—from which initial safety data was presented in October at MSParis2017, the 7th Joint Meeting of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) and the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS).

According to that safety data, which came from the first month of EVOLVE-MS-1, treatment with ALKS 8700 was associated with low rates of gastrointestinal (GI) adverse events (AEs) leading to discontinuation (0.5%) and no occurrence of serious GI AEs.

A second safety study, EVOLVE-MS-2, is underway and designed to evaluate the GI tolerability of ALKS 8700 compared to Tecfidera. Initial data from EVOLVE-MS-2 is expected in the first half of 2018, Biogen and Alkermes said.

Biogen will oversee all commercialization activities for ALKS 8700 and has agreed to pay Alkermes a mid-teens royalty on worldwide net sales of ALKS 8700, the companies added.

Alkermes CEO Richard Pops said in a statement that his company would refocus its growing commercial capabilities on its expanding portfolio of treatments in psychiatry, including addiction, schizophrenia, and depression.

“This collaboration has the potential to provide important benefits to patients with MS and immediately increases the value of ALKS 8700 to Alkermes,” Pops stated. “Biogen has a broad product portfolio and a highly experienced commercial team. In Biogen’s hands, we believe that patients will have broader and more rapid access to this important medicine.”

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