Nordic Bioscience A/S and Merck KGaA complete randomization of multi-center Phase 2b study of Sprifermin for Osteoarthritis of the knee earlier than planned

· On May 12th the enrollment of this Phase 2 trial of patients with osteoarthritis of the knee was completed

· Enrollment was achieved in 8 months, 2 weeks earlier than estimated

Copenhagen, Denmark, May 12, 2014 – Nordic Bioscience today announced that it has completed the enrollment of 545 patients in the phase 2b study of Merck’s investigational drug Sprifermin (recombinant human FGF-18. AS902330) in osteoarthritis (OA) of the knee. This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group Phase 2 trial of Sprifermin administered intra-articularly in patients with primary osteoarthritis of the knee and Kellgren-Lawrence Grade 2 or 3. The trial is intended to investigate the efficacy and safety of different intra articular dosages of Sprifermin in these individuals. The 545 patients are distributed across 9 sites in 6 countries. More information is available on clinicaltrials.gov.

The first patient entered the trial on August 14, 2013 and now 8 months later, enrollment has been completed. “We had estimated 9 months to randomize all 545 patients, which was an aggressive timeline. However, based on our experience in conducting trials in musculoskeletal diseases, we were confident that it was possible to finish ahead of time”, said Jeppe Ragnar Andersen, CEO, Nordic Bioscience Clinical Development A/S.

This marks an important milestone in the development of this compound, now one step closer to generating the evidence necessary to become the first approved disease-modifying treatment for osteoarthritis.

Kathy Ford, Senior Vice President, Clinical Operations at Merck KGaA states: "Osteoarthritis is a wide-spread, painful disease, for which there are no treatments available to alter the course of the disease. This achievement is a pivotal step towards providing these patients with a much needed therapeutic option, and we are extremely pleased with the performance of our partner, Nordic Bioscience, to help us achieve this goal even earlier than we had hoped.”

Nordic Bioscience and Merck entered into the strategic alliance in early 2013 to develop Sprifermin. 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 is utilizing joint expertise and resources of Merck and Nordic Bioscience to conduct a multi-national Phase 2b 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.

Sprifermin, a protein thought to induce chondrocyte stimulation leading to matrix synthesis and chondrocyte renewal, is delivered by intra-articular injection. Two phase 1 trials in moderate/severe OA of the knee were previously completed.

According to the World Health Organization, more than 5% of adults over 40 in developed countries, or more than 30 million people, suffer from OA of the knee.

About Nordic Bioscience

Nordic Bioscience is an international biotech organization with research and development facilities in Copenhagen, Denmark. The company comprises three divisions: Biomarkers & Research, Clinical Development, and the Laboratory. It is a group with the capacity and specialist expertise to develop protocols for, manage, and support studies ranging from those in early preclinical phases to the pivotal phase IIIs required for marketing authorization.

About Merck

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.

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