Date: 2013-03-18
Type of information: Clinical research agreement
Compound: sprifermin (recombinant human fibroblast growth factor (FGF)-18)
Company: Merck KGaA, Merck Serono (Germany) Nordic Bioscience (Denmark)
Therapeutic area: Rheumatic diseases - Inflammatory diseases – Bone diseases
Type agreement: R&D - clinical research
Action mechanism:
- protein. Sprifermin is a truncated recombinant human FGF-18 protein thought to induce chondrocyte proliferation and increased extra-cellular matrix production, with the potential of promoting cartilage growth and repair. The program was originally in-licensed in 2004 from ZymoGenetics, a Bristol-Myers Squibb company.
Disease: osteoarthritis of the knee
Details:
- • On March 18, 2013, Merck has announced a strategic alliance with Nordic Bioscience Clinical Development A/S on Merck’s investigational drug sprifermin (recombinant human FGF-18) in osteoarthritis (OA) of the knee. Under the terms of the agreement, Nordic Bioscience will provide clinical development services to Merck on a shared-risk basis in exchange for a payment structure that includes service fees and potential milestone and royalty payments on the program. Merck retains full responsibility for the development and commercialization of the investigational drug. The alliance will draw on the joint expertise and resources of Merck and Nordic Bioscience to conduct a multi-national Phase IIb trial (the FORWARD study) to further evaluate sprifermin for inhibition of the progression of structural damage, reduction of pain and improvement of physical function in patients with OA of the knee. The FORWARD study is expected to begin enrollment in the second half of 2013.
- Two phase I trials in moderate/severe OA of the knee were previously completed; a Phase II trial to evaluate the efficacy and safety in patients with cartilage injury of the knee is currently ongoing. The program was originally in-licensed in 2004 from ZymoGenetics, a BMS company.
Financial terms: Financial terms of the collaboration were not disclosed.
Latest news:
Is general: Yes
