Grünenthal to license osteoarthritis ache therapy to Shionogi in Japan in deal of as much as > $ 500 million


Aachen, Germany – Four August 2022 – Grünenthal and Shionogi introduced immediately that they’ve entered right into a licensing settlement for Grünenthal’s investigational medication Resiniferatoxin (“RTX”). Shionogi obtained the unique rights to commercialise Grünenthal’s asset in Japan for ache related to osteoarthritis of the knee.

RTX is at the moment in Part III of medical improvement for the therapy of sufferers with reasonable to extreme ache related to knee osteoarthritis. Osteoarthritis, a progressive and infrequently painful joint illness, is a sign with excessive unmet medical want. If permitted, RTX may grow to be a well-tolerated, non-opioid remedy choice for sufferers, offering long-lasting ache reduction and purposeful enchancment of the affected knee joints.

Underneath the phrases of the settlement, Shionogi will receive the unique commercialisation rights for RTX in Japan for a complete consideration of as much as $ 525 million plus further gross sales primarily based funds. Thereof, Shionogi pays $ 75 million upon signature, and additional milestone funds of $ 70 million previous to regulatory approval. The settlement contains aggressive funding commitments for launch and commercialisation. Manufacturing and provide of RTX to Shionogi will probably be carried out completely by Grünenthal.

“RTX is a promising asset for greater than 300 million sufferers worldwide who are suffering from osteoarthritis [1] and search a significant non-opioid remedy choice”, says Gabriel Baertschi, Chief Government Officer, Grünenthal. “With their established presence, sturdy business capabilities and wealth of expertise within the ache market, Shionogi is our companion of option to efficiently convey RTX to sufferers in Japan.”

RTX is a extremely potent Transient Receptor Potential Vanilloid 1 (TRPV1) agonist with a well-validated mechanism of motion. An ongoing medical Part III programme throughout websites in Europe, the US, Latin America, South Africa and Japan goals to allow advertising and marketing approval for the investigational medication. New drug purposes, together with Japan, are focused for 2024, resulting in a possible market entry of RTX in 2025. If the result of the Part III programme is optimistic, Grünenthal intends to discover the potential of RTX for the therapy of osteoarthritis-related ache in different joints past the knee. The worldwide osteoarthritis market is anticipated to develop to roughly $ 11.zero billion in 2025 [2]. Japan represents one of the vital markets in Asia, with important income potential for RTX.

[1] Cieza, A., Causey, Ok., Kamenov, Ok., Hanson, S. W., Chatterji, S., & Vos, T. (2020). World estimates of the necessity for rehabilitation primarily based on the World Burden of Illness research 2019: a scientific evaluation for the World Burden of Illness Research 2019. The Lancet, 396(10267), 2006-2017.

[2] MarketsAndMarkets Report; Osteoarthritis Therapeutics Market by Anatomy (Knee, Hand), Drug Sort (NSAIDs, Analgesics, Corticosteroids), Route of Administration (Parenteral), Distribution Channel (Hospital Pharmacies),Buying Sample (Prescription Medication) – World Forecast to 2025; 2020. https://www.marketsandmarkets.com/Market-Stories/osteoarthritis-therapeutics-market-209565994.html

About RTX
RTX is an intra-articular injection of resiniferatoxin developed for the therapy of ache in sufferers with reasonable to extreme ache related to knee osteoarthritis. Resiniferatoxin is a extremely potent Transient Receptor Potential Vanilloid 1 (TRPV1) agonist. Its administration can reversibly defunctionalise TRPV1-expressing nociceptors. This will lead to long-lasting ache reduction. Preliminary knowledge exhibits a long-lasting and important analgesic impact and purposeful enhancements in comparison with placebo, in addition to a beneficial security profile.

About Osteoarthritis
Osteoarthritis (OA) will be outlined as a bunch of distinct however overlapping ailments. They might have totally different etiologies however related organic, morphological, and medical outcomes that have an effect on the articular cartilage, subchondral bone, ligaments, joint capsule, synovial membrane, and periarticular muscle groups. OA is the most typical joint illness in individuals aged 65 and over. Its etiology shouldn’t be totally understood, though a number of associated elements embrace feminine gender, genetics, metabolism, and extreme mechanical stress. The analysis of OA is based on the medical historical past and bodily examination. The cardinal radiographic options of OA are focal/non-uniform narrowing of the joint area within the areas subjected to probably the most stress, subchondral cysts, subchondral sclerosis, and osteophytes. [3]

Osteoarthritis is a joint illness by which the tissues within the joint break down over time. Frequent signs of osteoarthritis embrace joint ache, stiffness and swelling, in addition to adjustments in how the joint strikes and feeling just like the joint is free or unstable. Essentially the most generally affected joints embrace the knees, hips, palms, neck and decrease again. Therapy of osteoarthritis often contains workouts, sustaining a wholesome weight, sporting braces to assist with stability, and taking remedy, if prescribed. [4] Many sufferers will in the end require joint alternative surgical procedure.

About Shionogi
Shionogi & Co., Ltd. is a number one international research-driven pharmaceutical firm primarily based in Japan, devoted to bringing advantages to sufferers primarily based on its company philosophy of “supplying the absolute best medication to guard the well being and wellbeing of the sufferers we serve.” We have now declared that it’s going to deal with psychoneurological ailments and ache as precedence ailments in addition to infectious ailments and contributed to bettering the actions of day by day residing and high quality of life and productiveness of individuals affected by ache. For extra info, please go to https://www.shionogi.com/international/en/contact.html

About Grünenthal
Grünenthal is a world chief in ache administration and associated ailments. As a science-based, fully-integrated pharmaceutical firm, we’ve got a protracted observe report of bringing modern remedies and state-of-the-art applied sciences to sufferers worldwide. Our goal is to alter lives for the higher – and innovation is our ardour. We’re focusing all of our actions and efforts on working in the direction of our imaginative and prescient of a world freed from ache.

Grünenthal is headquartered in Aachen, Germany, and has associates in 28 nations throughout Europe, Latin America and the US. Our merchandise can be found in additional than 100 nations. In 2021, Grünenthal employed round 4,500 individuals and achieved gross sales of € 1.5 bn.

[3] ICD-11 https://icd.who.int/browse11/l-m/en#/httppercent3apercent2fpercent2fid.who.intpercent2ficdpercent2fentitypercent2f558562409

[4] Nationwide Institute of Arthritis and Musculoskeletal and Pores and skin Ailments; What Causes Osteoarthritis, Signs & Extra | NIAMS (nih.gov)

Extra info: www.grunenthal.com

Click on right here for our Grünenthal Report 2021/2022: https://options.grunenthal.com/gruenenthal-annual-report-2021-22/index.html

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For additional info please contact
Florian Dieckmann
Head World Communication
Grünenthal GmbH
52099 Aachen
Telephone: +49 241 569-2555
E-mail: [email protected]

Christopher Jansen
Communication Enterprise Accomplice
Grünenthal GmbH
52099 Aachen
Telephone: +49 241 569-1428
E-mail: [email protected]





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