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Grünenthal and NovaQuest enter agreement to advance the resiniferatoxin global Phase III program in osteoarthritis

Aachen, Germany, and Raleigh, North Carolina – USA, 29 March 2022 – Grünenthal and NovaQuest announced today that they have entered an agreement to advance the global clinical Phase III  programme of Grünenthal’s asset resiniferatoxin (RTX). The investigational medicine is being  developed with the aim of providing patients suffering from pain associated with osteoarthritis with  a well-tolerated, non-opioid therapy option that is intended to provide long-lasting pain relief and  functional improvement of the affected joints.

RTX is a highly potent Transient Receptor Potential Vanilloid 1 (TRPV1) agonist with a well-validated  mechanism of action. The Phase III trials will investigate the efficacy, safety and tolerability of RTX in  patients with pain associated with osteoarthritis of the knee. The trials will start in 2022 and are  designed to meet the requirements for marketing approval in the EU, the US, and Japan.

“Globally, more than 300 million patients suffer from osteoarthritis1. For many of them, the available  treatment options are not sufficient and they may at some point in time experience severe  symptoms including pain”, says Jan Adams, MD, Chief Scientific Officer Grünenthal. “We are  delighted to partner with NovaQuest to invest into the development of this promising asset that may  provide benefits to patients who suffer from pain associated with osteoarthritis. This agreement provides Grünenthal headroom for further investments in the execution of its growth strategy and the advancement of a promising pipeline into the clinic.”

Under the terms of the agreement, NovaQuest will reimburse Grünenthal’s investments into the  clinical phase III programme of RTX and share the clinical development and approval risks with  Grünenthal. In case of successful development and marketing approval, NovaQuest receives one time payments or milestones and revenue-based payments over the course of the  commercialization.

“NovaQuest is excited to partner with the leading company in the therapeutic area of pain to  develop RTX, a promising asset that may enter the market as soon as 2025,” says Ryan Wooten,  Managing Director at NovaQuest. “We are confident that Grünenthal has the right capabilities in  place to position RTX on the global osteoarthritis market and leverage the full potential of the asset  for patients in need.” 

Grünenthal holds the global rights for RTX and is well-positioned to tap into the global osteoarthritis market that is expected to exhibit strong growth from $7.3 billion in 2020 to approximately $11.0 billion in 20252, constituting a large global commercial opportunity. For the indication of knee  osteoarthritis only, Grünenthal estimates potential peak sales to be above €1 billion in Europe and  the United States. In addition, Grünenthal intends to explore the potential of RTX for the treatment  of osteoarthritis-related pain in additional joints beyond the knee.

Osteoarthritis is a progressive condition that currently cannot be cured. The inflamed, swollen, and  painful joints limit the mobility of the affected patients and may impact their quality of life  significantly.

About Novaquest 

NovaQuest Capital Management, located in North Carolina’s Research Triangle, is a life science investment firm  with a specialization in biopharmaceuticals. Founded in 2010, and with more than $2.5 billion raised across  four funds, NovaQuest provides tailored capital solutions that fund innovation in biopharmaceutical  development and invests in compelling healthcare companies with products and technologies aimed at helping  humans and animals live healthier, longer, more productive lives.

Learn more at www.novaquest.com.

About RTX 

RTX is an intra-articular injection of resiniferatoxin developed for the treatment of pain in patients with  advanced knee osteoarthritis. Resiniferatoxin is a highly potent Transient Receptor Potential Vanilloid 1  (TRPV1) agonist. Its administration can reversibly defunctionalise TRPV1-expressing nociceptors. This may result in long lasting pain relief. Initial data shows a long-lasting and significant analgesic effect and functional  improvements compared to placebo, as well as a favourable safety profile.

About Osteoarthritis 

Osteoarthritis (OA) can be defined as a group of distinct but overlapping diseases. They may have different  etiologies, but similar biological, morphological, and clinical outcomes that affect the articular cartilage,  subchondral bone, ligaments, joint capsule, synovial membrane, and periarticular muscles. OA is the most  common joint disease in people aged 65 and over. Its etiology is not fully understood, although there are  several related factors including female gender, genetics, metabolism, and excessive mechanical stress. The  diagnosis of OA is primarily based on clinical history and physical examination. The cardinal radiographic  features of OA are focal/non-uniform narrowing of the joint space in the areas subjected to the most pressure,  subchondral cysts, subchondral sclerosis, and osteophytes.3

Osteoarthritis is a joint disease in which the tissues in the joint break down over time. Common symptoms of  osteoarthritis include joint pain, stiffness and swelling, as well as changes in how the joint moves and feeling  like the joint is loose or unstable. The most commonly affected joints include the hands, knees, hips, neck and  lower back. Treatment of osteoarthritis usually includes exercises, maintaining a healthy weight, wearing braces to help with stability, and taking medication, if prescribed.4 Many patients will require joint replacement  surgery.

About Grünenthal 

Grünenthal is a global leader in pain management and related diseases. As a science-based, privately-owned  pharmaceutical company, we have a long track record of bringing innovative treatments and state-of-the-art  technologies to patients worldwide. Our purpose is to change lives for the better and innovation is our passion.  We are focusing all of our activities and efforts on working towards our vision of a world free of pain.

Grünenthal is headquartered in Aachen, Germany, and has affiliates in 29 countries across Europe, Latin  America and the US. Our products are available in more than 100 countries. In 2020 Grünenthal employed  around 4,500 people and achieved sales of € 1.3 bn.

More information: www.grunenthal.com

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Instagram: grunenthal

For further information please contact

Florian Dieckmann
Head Global Communication

Grünenthal GmbH
52099 Aachen
Phone: +49 241 569-2555
E-mail: Florian.Dieckmann@grunenthal.com

Brian Person
Head of Investor Relations 

NovaQuest Capital Management, LLC
4208 Six Forks Road (Suite 920)
Phone: +1 919-459-8628
E-mail: brian.person@nqcapital.com

NovaQuest Press Contact:

Philip Nunes
phil.nunes@backbaycommunications.com

1 Cieza, A., Causey, K., Kamenov, K., Hanson, S. W., Chatterji, S., & Vos, T. (2020). Global estimates of the need  for rehabilitation based on the Global Burden of Disease study 2019: a systematic analysis for the Global  Burden of Disease Study 2019. The Lancet, 396(10267), 2006-2017.

2 MarketsAndMarkets Report; Osteoarthritis Therapeutics Market by Anatomy (Knee, Hand), Drug Type  (NSAIDs, Analgesics, Corticosteroids), Route of Administration (Parenteral), Distribution Channel (Hospital  Pharmacies),Purchasing Pattern (Prescription Drugs) – Global Forecast to 2025; 2020. https://www.marketsandmarkets.com/Market-Reports/osteoarthritis-therapeutics-market-209565994.html

3ICD-11 https://icd.who.int/browse11/l-m/en#/http%3a%2f%2fid.who.int%2ficd%2fentity%2f558562409

4 National Institute of Arthritis and Musculoskeletal and Skin Diseases; What Causes Osteoarthritis, Symptoms  & More | NIAMS (nih.gov)