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. Financial terms of the collaboration were not disclosed.
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.
"Building and executing innovative partnerships that optimize and complement Merck Serono's capabilities and facilitate the balancing of risk across the pipeline is a core element of the company's overall development strategy," said Susan Herbert, Executive Vice President of Global Business Development and Strategy for the Merck Serono division. "Nordic Bioscience Clinical Development’s deep expertise in osteoarthritis and proven track record of specialist trial recrui tment will enable us to effectively and efficiently move to the next stage of clinical evaluation for sprifermin."
Claus Christiansen, Founder and Chairman of Nordic Bioscience, commented: "Partnering with Merck allows us to utilize our clinical trial and biomarker expertise within musculoskeletal diseases on an exciting investigational drug such as sprifermin and with a well-known sponsor such as Merck. We specialize in and believe in this type of partnering."
Sprifermin, a protein thought to induce chondrocyte stimulation leading to matrix synthesis and chondrocyte renewal, is delivered by intra-articular injection. 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 Bristol-Myers Squibb company.
According to the World Health Organization, more than 5% of adults over 40 in developed countries, or more than 30 million people, suffer from osteoarthritis of the knee.
About Merck KGaA
Merck is a leading pharmaceutical, chemical and life science company with total revenues of € 11.2 billion in 2012, a history that began in 1668, and a future shaped by approx. 39,000 employees in 66 countries. Its success is characterized by innovations from entrepreneurial employees. Merck's operating activities come under the umbrella of Merck KGaA, in which the Merck family holds an approximately 70% interest and free shareholders own the remaining approximately 30%. In 1917 the U.S. subsidiary Merck & Co. was expropriated and has been an independent company ever since.