Biogen Pays Alkermes $50 Million Milestone for MS Drug
Published: Jun 06, 2018 By Mark Terry
Alkermes, headquartered in Dublin, Ireland, received a $50 million milestone payment from Cambridge, Massachusetts-based Biogen. The payment occurred after Biogen reviewed preliminary gastrointestinal tolerability data from an ongoing Phase III clinical trial of BIIB098 (diroximel fumarate) for relapsing forms of multiple sclerosis (MS).
Under the terms of their agreement, Biogen has exclusive commercialization rights to the drug. Alkermes is eligible for a royalty in the mid-teens on worldwide net sales, should the drug be approved. Alkermes is also eligible for a $150 million milestone payment if the U.S. Food and Drug Administration (FDA) approves the drug, on or before December 31, 2021.
Alkermes is expected to submit a New Drug Application (NDA) for the drug to the FDA in the last quarter of this year.
The original deal was signed in November 2017, when the drug was dubbed ALKS 8700. It is a novel, oral, monomethyl fumarate (MMF) small drug molecule. Biogen reimbursed Alkermes for half of the 2017 development costs and paid Alkermes an upfront payment of $28 million, which represented Biogen’s share of development expenses already incurred that year.
Starting at the beginning of 2018, Biogen handled all development expenses related to the drug. Alkermes is eligible for milestone payments up to $200 million—which is already received $50 million. Alkermes will handle regulatory applications with the FDA, and Biogen will handle commercial activities for the drug, if approved.
The primary components of the EVOLVE-MS (Endeavoring to Advance Treatment for Patients Living with Multiple Sclerosis) clinical program of ALKS 8700/BIIB098 include a two-year safety trial and pharmacokinetic bridging studies comparing the drug and Tecfidera. The program also includes an elective head-to-head study comparing the GI tolerability of the drug and Tecfidera.
“The clinical data generated from this program underscore the potential value of BIIB098 for patients with multiple sclerosis,” said Richard Pops, Alkermes’ chief executive officer, in a statement. “Our focus remains on completing the registration requirements and preparing the BIIB098 NDA for submission in the fourth quarter of 2018, as we advance this important potential new therapeutic option for patients with MS.”
Alkermes is a busy company, with a market cap of $7.19 billion. It markets Aristada for schizophrenia, Vivitrol for alcohol and opioid dependence, Risperdal Consta for schizophrenia and bipolar I disorder, Invega Sustenna for schizophrenia and schizoaffective disorder, Xeplion, Invega Trinza, and Trevicta for schizophrenia, Ampyria/Fampyra to enhance walking in MS patients, and Bydureon for type 2 diabetes. It currently has ALKS 5461 in Phase III trials for depressive disorder, ALKS 3831 in Phase III for schizophrenia, ALKS 8700 for MS, and ALKS 6428 in Phase III to assist physicians transition patients from physical dependent on opioids. Its Aripiprazole lauroxil recently finished a Phase I trial for schizophrenia, and ALKS 4230 is in Phase I clinical trials for cancer immunotherapy.
Biogen, a leader in MS treatments, announced yesterday that it had expanded its strategic collaboration with Ionis Pharmaceuticals to discover and develop novel antisense drugs for neurological diseases. Biogen paid Ionis $1 billion in cash, including $625 million for 11,501,153 shares of Ionis common stock at a price of $54.34 per share and a $375 million upfront payment. The expansion was originally announced on April 20, 2018. The companies expect to advance programs for diseases including dementia, neuromuscular diseases, movement disorders, ophthalmology, diseases of the inner ear, and neuropsychiatry.