Merck KGaA, Darmstadt, Germany Announces Out-licensing Agreement for Osteoarthritis Asset Sprifermin

Merck KGaA, Darmstadt, Germany, a leading science and technology company, has, through its subsidiary Ares Trading S.A., entered into an out-licensing agreement for sprifermin with TrialSpark/High Line Bio, New York, USA. Sprifermin, a recombinant form of human fibroblast growth factor 18, is currently being investigated in patients with osteoarthritis (OA). As part of the agreement, Merck KGaA, Darmstadt, Germany will receive an upfront payment as well as equity in TrialSpark/High Line Bio and is eligible for milestone payments related to delivering on certain development and commercial milestones, in addition to royalties on any future net sales. TrialSpark/High Line Bio will assume full responsibility for the research, development and commercialization of sprifermin.

This agreement is a part of the strategic evolution of Merck KGaA, Darmstadt, Germany´s immunology pipeline, allowing the company to deliver the greatest impact for patients by building focused leadership positions in neuroinflammatory and immune-mediated conditions with evobrutinib, currently in Phase III development for relapsing Multiple Sclerosis (RMS), cladribine in early-stage development for generalized myasthenia gravis (gMG) and neuromyelitis optica spectrum disorder (NMOSD), and enpatoran - a novel TLR 7/8 inhibitor - entering Phase II studies in Systemic Lupus Erythematosus (SLE) and Cutaneous Lupus Erythematosus (CLE).

Sprifermin is delivered by injection into the joint every 6 or 12 months. The results of the five-year, multicenter Phase II study FORWARD were published in the Journal of the American Medical Association and showed that sprifermin significantly improved cartilage thickness in knee OA after two years. The complete five-year data from what is the longest trial assessing the efficacy and safety of a potential disease-modifying OA treatment reported to date were published in Annals of the Rheumatic Diseases earlier this year and showed that sprifermin maintained long-term structural modification of articular cartilage over 3.5 years post-treatment.

OA is the most common form of arthritis. There are approximately 237 million people worldwide living with symptomatic and activity-limiting OA[1] - the third most rapidly rising condition associated with disability globally[2]. Currently, OA therapies primarily target symptoms and there are no approved structure-modifying OA treatments for preventing or slowing disease progression.

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[1] GBD Collaborators et al. Global, regional, and national incidence, prevalence, and years lived with disability for 310 diseases and injuries, 1990–2015: a systematic analysis for the Global Burden of Disease Study 2015. Lancet 2016;388:1545–602

[2] Osteoarthritis Research Society International. Osteoarthritis: a serious disease. https://www.oarsi.org/sites/default/files/docs/2016/oarsi_white_paper_oa-serious-disease.pdf [Accessed October 2021]