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

RTX is a highly potent transient receptor potential vanilloid 1 (TRPV1) agonist with a well-validated mechanism of action. Phase III studies will examine the efficacy, safety and tolerability of RTX in patients with pain associated with knee osteoarthritis. Trials will begin in 2022 and are designed to meet requirements for marketing approval in the EU, US and Japan.

« Globally, more than 300 million patients suffer from osteoarthritis [1]. For many of them, there are not enough treatment options available and at some point they may experience severe symptoms including pain, » says Jan Adams, MD, Chief Scientific Officer Grünenthal. « We are delighted to partner with NovaQuest to invest in the development of this resource promising that it may provide benefits to patients suffering from pain associated with osteoarthritis. This deal provides Grünenthal with room for further investment in executing its growth strategy and advancing a promising pipeline in the clinic. »

Under the terms of the agreement, NovaQuest will repay Grünenthal’s investment in RTX’s Phase III clinical program and share clinical development and approval risks with Grünenthal. Upon successful development and marketing approval, NovaQuest receives one-time or milestone payments and revenue-based payments in the course of commercialization.

“NovaQuest is excited to partner with the leading pain management company to develop RTX, a promising asset that could enter the market as early as 2025,” said Ryan Wooten, chief executive officer of NovaQuest. « We are confident that Grünenthal has the right capabilities to position RTX in the global osteoarthritis market and leverage the full potential of the resource for patients who need it. »

Grünenthal holds the global rights to RTX and is well positioned to tap into the global osteoarthritis market which is expected to show strong growth from $7.3 billion in 2020 to approximately $11.0 billion in 2025 [2]which constitutes a major global business opportunity. For the knee osteoarthritis indication alone, Grünenthal estimates the potential peak sales to be more than 1 billion euros in Europe and the United States. Additionally, Grünenthal plans to explore the potential of RTX for treating osteoarthritis-related pain in additional joints beyond the knee.

Osteoarthritis is a progressive condition that currently cannot be cured. Inflamed, swollen and painful joints limit the mobility of affected patients and can have a significant impact on their quality of life.

About Novaquest
NovaQuest Capital Management, headquartered in the North Carolina research triangle, is a life sciences investment firm specializing 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 invest in compelling healthcare companies with products and technologies aimed at helping humans and animals to live healthier, longer and more productive lives.

Learn more about www.novaquest.com.

About RTX
RTX is an intra-articular injection of resiniferatoxin developed for the treatment of pain in patients with advanced osteoarthritis of the knee. Resiniferatoxin is a very potent agonist of the transient receptor vanilloid potential 1 (TRPV1). Its administration can reversibly defunctionalize TRPV1-expressing nociceptors. This can result in long-lasting pain relief. Initial data show a durable and significant analgesic effect and functional improvements compared to placebo, as well as a favorable 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 affecting articular cartilage, subchondral bone, ligaments, joint capsule, synovial membrane, and periarticular muscles. OA is the most common joint disease in people 65 years of age and older. 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 based primarily on the clinical history and physical examination. The cardinal radiographic findings of OA are focal/nonuniform narrowing of the joint space in areas of greatest 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 the way the joint moves and a feeling that 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 exercising, maintaining a healthy weight, wearing braces to help with stability, and taking medications, if prescribed. [4] Many patients require joint replacement surgery.

About Grünenthal
Grünenthal is a global leader in the management of pain and related diseases. As a science-based privately held pharmaceutical company, we have a long track record of bringing innovative treatments and cutting-edge technologies to patients around the world. 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 toward our vision of a pain-free world.

Grünenthal is headquartered in Aachen, Germany, and has subsidiaries in 29 countries in Europe, Latin America and the United States. Our products are available in more than 100 countries. In 2020, Grünenthal employed around 4,500 people and achieved a turnover of 1.3 billion euros.

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

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

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

[4] National Institute of Arthritis and Musculoskeletal and Skin Diseases; What causes osteoarthritis, symptoms and more | NIAMS (nih.gov)

More information: www.grunenthal.com

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For more information please contact
Florian Dieckman
Head of Global Communications

Grünenthal GmbH
52099 Aachen
Telephone: +49 241 569-2555
Email: Florian.Dieckmann@grunenthal.com

Brian Person
Investor Relations Manager

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

NovaQuest press contact:
Philip Nunes
phil.nunes@backbaycommunications.com