Grünenthal and NovaQuest enter into agreement to take Reginiferatoxin worldwide

Aachen, Germany, and Raleigh, North Carolina – United States, March 29, 2022 – Grünenthal and NovaQuest announced today that they have entered into an agreement to advance Grünenthal’s resource Resiniferatoxin (RTX) ‘s global clinical phase III program. Investigative medicine is being developed to provide patients with pain associated with osteoarthritis with a well-tolerated, non-opioid therapy alternative that aims to relieve chronic pain and improve the functioning of affected joints.

RTX is a highly potent transient receptor potential vanilla 1 (TRPV1) agonist with a well-proven mechanism of action. Phase III trials will investigate the efficacy, safety, and tolerability of RTX in patients with osteoarthritis of the knee. The trials will begin in 2022 and are designed to meet marketing approval requirements in the EU, US and Japan.

“Worldwide, more than 300 million patients suffer from osteoarthritis [1]. For many of them, the available treatment options are not enough and they may experience serious symptoms, including pain at one time, “said Granenthal, MD, chief scientific officer at Jane Adams.” Can benefit patients. The agreement provides Gruenthal with headroom for further investment in the implementation of its growth strategy and the progress of a promising pipeline to the clinic. “

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

Ryan Utten, Managing Director of NovaQuest, said, “NovaQuest is interested in partnering with a leading company in the field of pain therapeutics to develop RTX, a promising asset that could enter the market by 2025.” “We are confident that Grunenthal has the right capabilities to position RTX in the global osteoarthritis market and take full advantage of the resources available to patients in need.”

Grünenthal holds global rights for RTX and is in a good position to tap the global osteoarthritis market, which is expected to show strong growth from $ 7.3 billion in 2020 to about .0 11.0 billion in 2025. [2], Forming a large global trade opportunity. Just to indicate osteoarthritis of the knee, Grenthal estimates the potential maximum sales in Europe and the United States will be above € 1 billion. In addition, Grünenthal wants to explore the potential of RTX for the treatment of osteoarthritis-related pain in extra joints outside the knee.

Osteoarthritis is a progressive condition that is currently incurable. Swollen, swollen and painful joints limit the mobility of infected patients and can significantly affect their quality of life.

About Novaquest
NovaQuest Capital Management, located in the North Carolina Research Triangle, is a life science investment firm that specializes in biopharmaceuticals. Founded in 2010, and raising more than 2.5 billion across four funds, NovaQuest provides appropriate capital solutions that fund innovations in biopharmaceutical development and invest in mandatory healthcare organizations, including products and technologies, to help people and animals live healthier, longer, more productive lives. By .

Learn more at www.novaquest.com.

About RTX
RTX is an intra-articular injection of resinferatoxin designed to treat pain in patients with advanced knee osteoarthritis. Resiniferatoxin is a highly potent transient receptor potential vanilloid 1 (TRPV1) agonist. Its administration can reverse TRPV1-releasing nociceptors. This can relieve chronic pain. Preliminary data show a long-lasting and significant analgesic effect and effective improvement over placebo, as well as an optimal 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 muscle. OA is the most common joint disease in people 65 years of age or older. Its etiology is not fully understood, although there are several related factors, including female sex, genetics, metabolism, and excessive mechanical stress. OA diagnosis is based primarily on clinical history and physical examination. The main radiographic features of OA are high pressure, focal / non-uniform narrowing of the joint space in the case of subchondral cysts, subchondral sclerosis, and osteophytes. [3]

Osteoarthritis is a disease of the joint where the joint tissue breaks down over time. Common symptoms of osteoarthritis include joint pain, stiffness and swelling, as well as changes in joint movement and a feeling of loosening or dislocation of the joint. The most affected joints are the hands, knees, buttocks, neck and lower back. Treatment for osteoarthritis usually includes exercise, maintaining a healthy weight, wearing braces to help maintain stability, and taking medication if prescribed. [4] Many patients will need joint replacement surgery.

About Grenthal
Grünenthal is a global leader in pain management and related diseases. As a science-based, privately owned pharmaceutical company, it has a long track record of bringing innovative medicine and cutting-edge technology to patients worldwide. Our purpose is to change lives for the better and innovation is our passion. We are focused on all our activities and efforts to work towards our vision of a pain free world.

Grünenthal is headquartered in Aachen, Germany and approved in 29 countries across Europe, Latin America and the United States. Our products are available in more than 100 countries. In 2020, Grünenthal employed about 4,500 people and sold 1.3 billion.

[1] Cieza, A., Causey, K., Kamenov, K., Hanson, SW, 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] Market and market reports; Osteoarthritis Therapeutic Market Anatomy (Knee, Hand), Types of Medicines (NSAIDs, Painkillers, Corticosteroids), Routes of Administration (Parenteral), Distribution Channel (Hospital Pharmacy), Purchase Pattern (Prescription 20); 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 Dermatology; What causes osteoarthritis, symptoms and more? NIAMS (nih.gov)

More info: www.grunenthal.com

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Contact for more information
Florian Dickman
Head Global Communications

Gruenthal GmbH
52099 Achen
Phone: +49 241 569-2555
Email: [email protected]

Brian person
The head of investor relations

NovaQuest Capital Management, LLC
4208 Six Forks Road (Suite 920)
Phone: +1 919-459-8628
Email: [email protected]

NovaQuest Press Contact:
Philip Nunes
[email protected]


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