INDIVIOR UK LIMITED

Indivior has successfully completed IND-enabling studies for its GABAB positive allosteric modulator (PAM) program in substance use disorders, marking the final preclinical development stage before clinical trials can begin.

The pharmaceutical industry has experienced significant leadership changes in early 2025, with major transitions at companies including Pfizer, Boehringer Ingelheim, and Takeda.

• The FDA is set to decide on Biogen and Eisai's Leqembi for monthly intravenous maintenance in early Alzheimer's disease, potentially improving patient convenience. • AstraZeneca and Daiichi Sankyo await a decision on Dato-DXd for metastatic HR-positive, HER2-negative breast cancer, offering a new antibody-drug conjugate approach. • Vertex's suzetrigine, a non-opioid analgesic for moderate-to-severe acute pain, anticipates FDA verdict, representing a novel drug class for pain management. • SpringWorks' mirdametinib is under priority review for neurofibromatosis type 1-associated plexiform neurofibromas, addressing a significant unmet need.

• The FDA granted Priority Review to Indivior's sNDA for SUBLOCADE®, setting a PDUFA date of February 7, 2025. • The sNDA seeks approval for alternative injection sites (thigh, buttock, back of the arm) for both induction and maintenance. • The submission includes a rapid induction protocol, reducing induction time to one hour after a single transmucosal buprenorphine dose. • If approved, these label updates would significantly enhance patient experience and expand treatment access for opioid use disorder.

• Aelis Farma's AEF0117 did not meet its primary endpoint of reducing cannabis use to one day or less per week in patients with moderate to severe cannabis use disorder (CUD). • The Phase 2B trial also failed to meet secondary endpoints, including complete cessation of marijuana use or reduction to two days or less per week. • Indivior, which had an option to license AEF0117, announced it does not currently expect to exercise this option due to the lack of separation from placebo in the trial. • AEF0117 was well-tolerated, with adverse events similar across treatment groups, including placebo, indicating no significant safety concerns.