Grünenthal to license osteoarthritis pain treatment to Shionogi

Family-owned German drugmaker Grünenthal and Japan’s Shionogi (TYO: 4507) have entered into a licensing agreement for Grünenthal's investigational medicine resiniferatoxin (RTX). Shionogi obtained the exclusive rights to commercialize Grünenthal's asset in Japan for pain associated with osteoarthritis of the knee.

RTX is currently in Phase III of clinical development for the treatment of patients with moderate to severe pain associated with knee osteoarthritis. Osteoarthritis, a progressive and often painful joint disease, is an indication with high unmet medical need. If approved, RTX could become a well-tolerated, non-opioid therapy option for patients, providing long-lasting pain relief and functional improvement of the affected knee joints.

Financial terms

Under the terms of the agreement, Shionogi will obtain the exclusive commercialization rights for RTX in Japan for a total consideration of up to $525 million plus additional sales-based payments. Thereof, Shionogi will pay $75 million upon signature, and further milestone payments of $70million prior to regulatory approval. The agreement includes competitive investment commitments for launch and commercialization. Manufacturing and supply of RTX to Shionogi will be carried out exclusively by Grünenthal.

"RTX is a promising asset for more than 300 million patients worldwide who suffer from osteoarthritis and seek a meaningful non-opioid therapy option," says Gabriel Baertschi, chief executive of Grünenthal, adding: "With their established presence, strong commercial capabilities and wealth of experience in the pain market, Shionogi is our partner of choice to successfully bring RTX to patients in Japan."

RTX is a highly potent Transient Receptor Potential Vanilloid 1 (TRPV1) agonist with a well-validated mechanism of action. An ongoing clinical Phase III program across sites in Europe, the USA, Latin America, South Africa and Japan aims to enable marketing approval for 0the investigational medicine. New drug applications, including Japan, are targeted for 2024, leading to a potential market entry of RTX in 2025. If the outcome of the Phase III program is positive, Grünenthal intends to explore the potential of RTX for the treatment of osteoarthritis-related pain in other joints beyond the knee.