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Grünenthal to license osteoarthritis pain treatment to Shionogi in Japan in deal of up to > $ 500 million


Aachen, Germany – 4 August 2022 – Grünenthal and Shionogi introduced as we speak 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 sometimes painful joint illness, is a sign with excessive unmet medical want. If accredited, RTX may turn into a well-tolerated, non-opioid remedy possibility 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 extra gross sales based mostly funds. Thereof, Shionogi can pay $ 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 shall be carried out solely 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 possibility”, says Gabriel Baertschi, Chief Government Officer, Grünenthal. “With their established presence, sturdy industrial capabilities and wealth of expertise within the ache market, Shionogi is our associate of option to efficiently deliver 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 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 end 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 predicted to develop to roughly $ 11.0 billion in 2025 [2]. Japan represents one of the vital markets in Asia, with important income potential for RTX.

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

[2] MarketsAndMarkets Report; Osteoarthritis Therapeutics Market by Anatomy (Knee, Hand), Drug Kind (NSAIDs, Analgesics, Corticosteroids), Route of Administration (Parenteral), Distribution Channel (Hospital Pharmacies),Buying Sample (Prescription Medication) – International Forecast to 2025; 2020. https://www.marketsandmarkets.com/Market-Reports/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) might be outlined as a gaggle of distinct however overlapping illnesses. They could have completely 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 mass. OA is the most typical joint illness in individuals aged 65 and over. Its etiology isn’t absolutely understood, though a number of associated elements embody 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 house within the areas subjected to essentially the most strain, subchondral cysts, subchondral sclerosis, and osteophytes. [3]

Osteoarthritis is a joint illness during which the tissues within the joint break down over time. Widespread signs of osteoarthritis embody joint ache, stiffness and swelling, in addition to adjustments in how the joint strikes and feeling just like the joint is free or unstable. Probably the most generally affected joints embody the knees, hips, arms, neck and decrease again. Therapy of osteoarthritis normally contains workouts, sustaining a wholesome weight, carrying 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 based mostly in Japan, devoted to bringing advantages to sufferers based mostly 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 concentrate on psychoneurological illnesses and ache as precedence illnesses in addition to infectious illnesses and contributed to enhancing the actions of day by day residing and high quality of life and productiveness of individuals affected by ache. For extra data, please go to https://www.shionogi.com/global/en/contact.html

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

Grünenthal is headquartered in Aachen, Germany, and has associates in 28 international locations throughout Europe, Latin America and the US. Our merchandise can be found in additional than 100 international locations. 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#/http%3a%2f%2fid.who.int%2ficd%2fentity%2f558562409

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

Extra data: www.grunenthal.com

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

Comply with us on:
LinkedIn: Grunenthal Group
Instagram: grunenthal

For additional data please contact
Florian Dieckmann
Head International Communication
Grünenthal GmbH
52099 Aachen
Cellphone: +49 241 569-2555
E-mail: Florian.Dieckmann@grunenthal.com

Christopher Jansen
Communication Enterprise Companion
Grünenthal GmbH
52099 Aachen
Cellphone: +49 241 569-1428
E-mail: Christopher.Jansen@grunenthal.com





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