Alar Pharmaceuticals, a trailblazer in the field of central nervous system disease research, is poised to make a significant impact with its expected market debut in late January. Specializing in innovative drug development, Alar Pharmaceuticals is harnessing the 505(b)(2) regulatory pathway to revolutionize treatment modalities.
The company’s flagship product, ALA-1000, is rapidly gaining traction as a promising treatment for chronic pain associated with opiate addiction. This long-acting subcutaneous injection is a result of Yuzhan’s dedication to refining raw materials and advancing dosage forms, aiming to offer superior treatment alternatives.
In a strategic move, Yuzhan has licensed ALA-1000 to Indivior, a global leader in drug addiction medication. The deal, finalized in March, includes a licensing fee potentially reaching up to $862 million, alongside a 10-15% share in product sales profits. Indivior is now spearheading the subsequent development and expenses, with detailed discussions underway with the US FDA regarding Phase III clinical trials of ALA-1000. The trial results are anticipated in the next year’s first quarter, with the launch expected as early as the following quarter.
Chairman Lin Donghe, who also founded Lotus Pharmaceutical, brings a wealth of experience in pharmaceutical R&D, sales, and operational management. Alar Pharmaceuticals’s General Manager Wen Yongshun, a former R&D director at Lamex, contributes over two decades of industry expertise. Together, they lead a robust management team, backed by significant shareholders such as China Development Medical Ventures and Fubon Financial Holdings Ventures.
Alar Pharmaceuticals retains ALA-1000’s licensing rights for human use in Greater China and companion animals globally. Negotiations are ongoing for the Chinese license, focusing on postoperative pain treatment in opioid addiction cases. This strategic positioning of ALA-1000 positions Alar Pharmaceuticals as a key player in addressing the growing need for effective treatments in the realm of central nervous system diseases and addiction therapy.
