Under the agreement, Alkermes will be responsible for obtaining regulatory approval of the drug, while Biogen will handle its marketing.
ALKS is taken orally. The body quickly transforms it into a compound known as monomethyl fumarate that can counter MS.
“This collaboration has the potential to provide important benefits to patients with multiple sclerosis and immediately increases the value of ALKS 8700 to Alkermes,” Richard Pops, Alkermes’ CEO, said in a press release. “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.”
The partnership gives Biogen worldwide marketing rights to ALKS 8700. Alkermes will receive a royalty on global sales.
“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,” said Michel Vounatsos, Biogen’s CEO. “We aim to provide patients with a new oral therapy which may bring differentiated benefits.”
Aikermes is evaluating ALKS 8700’s safety and effectiveness in what it has dubbed the EVOLVE-MS clinical trial program. It includes two Phase 3 trials that are comparing ALKS 8700 with Tecfidera in patients with relapsing-remitting MS, or RRMS.
Preliminary results of the EVOLVE-MS-1 trial (NCT02634307), which involved 580 patients, showed few gastrointestinal side effects from ALKS 8700. The most common adverse events in the first month of treatment were flushing, diarrhea, and a rash known as pruritus.
Aikermes discussed the treatments safety, and patients’ ability to tolerate it, at the 7th Joint ECTRIMS-ACTRIMS Meeting in Paris in October.
The company is still recruiting participants for a second trial that will compare ALKS 8700 and Tecfidera’s effect on the gastrointestinal system. The EVOLVE-MS-2 (NCT03093324) study will be conducted at locations in several U.S. states and six sites in Poland. Alkermes expects to release initial findings from the trial in the first half of 2018.