Alar Pharmaceuticals’ licensing partner Indivior reported second-quarter revenue and profit that exceeded expectations, which industry observers interpret as validation of its new management team’s focus on addiction-treatment drugs. This also means more resources are available to advance ALA-1000 (INDV-6001) into a Phase III clinical trial, set to begin no later than the first quarter of 2026. With trial enrollment underway, Alar is expected to receive a new wave of milestone payments, boosting profitability.
In October 2023, Alar out-licensed its long-acting opioid addiction injection therapy ALA-1000—in one-, three-, and six-month formulations—to Indivior, the global leader in addiction treatment, in a deal worth up to US$862 million. Indivior has designated ALA-1000 as a top priority project. To prepare for Phase III dose selection, it launched a multiple-dose pharmacokinetic study in the U.S. in 2024, enrolling 120 participants. About 100 have completed treatment, with no reports of local irritation or skin ulceration. Alar has also completed the technology transfer for both API and formulation, with trial supplies manufactured in Taiwan and provided to Indivior.
General Manager Yung Shun Wein noted that developing ALA-1000 (LR1000) into Phase III remains the set course, with no major changes expected. LR1000’s main advantage lies in being the only three-month long-acting injectable platform, making it more competitive than existing one-month formulations, while also allowing flexibility for one- or two-month dosing intervals. Indivior’s pharmacokinetic trials are testing one-, two-, and three-month regimens, with oral induction for seven days before switching to the long-acting injection, and development is also moving toward a six-month cycle.
Following a management reshuffle, Indivior has sharpened its focus on addiction-treatment drugs. In Q2, it reported US$302 million in revenue and adjusted EPS of US$0.51, significantly beating expectations. Analysts see this as confirmation of its new strategic direction and increased capacity to advance ALA-1000’s Phase III trial, which according to official plans, will start no later than Q1 2026.
Indivior’s injectable treatment Sublocade generated about US$800 million in sales in 2024, with first-quarter 2025 sales reaching US$200 million. Its main competitor, Buvidal/Brixadi, available in weekly and monthly formulations, is estimated to have annual U.S. sales of around US$200 million. By licensing ALA-1000 from Alar, Indivior aims to build a comprehensive product line and block competitors’ expansion.
Indivior officially expects Phase III to begin in Q1 next year. Under the licensing agreement, in addition to the US$15 million upfront payment already received, Alar is eligible for up to US$55 million in R&D milestone payments tied to the first licensed product, plus up to US$42 million in milestones for the other products. With Phase III enrollment moving forward, Alar anticipates a new round of milestone revenues, further driving profit growth.
Resource: ALA-1000明年Q1進三期臨床，昱展新藥迎新一波里程碑金入帳
