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news.Allay Therapeutics has announced a licensing agreement granting Maruishi Pharmaceutical exclusive rights to develop and commercialise ATX101, a non-opioid upivacaine-based drug, and other ultra-sustained analgesic implantable drug candidates for acute pain, in Japan.
Total knee arthroplasty surgeries market is estimated to be worth $1bn. Credit: Angelo Esslinger from Pixabay.
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ATX101 is designed for sustained, localised pain relief post total knee arthroplasty surgery.
Under the agreement, Allay will receive an upfront payment and equity investment. It is also eligible to get future milestone payments related to pre-defined clinical and regulatory events, both in the US and Japan, as well as commercial milestones and royalties on Japanese sales.
Allay retains development and commercialisation rights outside Japan for ATX101.
Maruishi president and representative director Katsuhito Inoue said: “We believe the ATX programmes will complement our existing local anesthetic products in Japan, and provide our doctors and patients an attractive alternative to the existing therapies with longer pain relief and better recoveries from surgery.”
Allay CEO Adam Gridley said: “We’re especially excited to partner with Maruishi given their similar mission to improve quality of life and ease post-surgical recovery. We believe that their internal expertise and long history with local anesthetic product R&D and strong relationships with key opinion leaders provide a natural fit to help accelerate the development of ATX101 and potentially deliver better pain management solutions for patients in Japan.”
Total knee arthroplasty surgeries market is estimated to be worth $1bn, which when combined with the economic burden of opioid abuse, highlights a significant need to reimage the pain management, claimed Allay.
Allay’s Phase 1b/2a study indicated a strong safety profile and two weeks of pain relief post-administration, with further evaluation underway in a randomised controlled Phase 2b study.
The partnership aims to progress ATX101 into necessary registration studies in both the US and Japan.
Renexes LLC advised Allay on the transaction, with Cooley LLP providing legal counsel.
