Date: 2014-06-17
Type of information: Termination of an agreement
Compound: ceralifimod (ONO-4641)
Company: Merck KGaA, Merck Serono (Germany) Ono Pharmaceutical (Japan)
Therapeutic area: Autoimmune diseases - Neurodegenerative diseases
Type agreement: licensing
development
commercialisation
Action mechanism: ONO-4641 is a sphingosine-1-phosphate (S1P) receptor agonist, and the multi-national phase II study, DreaMS (Drug Research EvaluAtion for Multiple Sclerosis) is on-going for the treatment of multiple sclerosis. The drug keeps lymphocytes in lymph nodes and thereby inhibits the infiltration of lymphocytes into lesions. The compound is therefore expected to be a drug for the treatment of auto-immune diseases such as multiple sclerosis, which is regarded as an intractable disease. ONO-4641 is a sphingosine-1-phosphate (S1P) receptor agonist, and the multi-national phase II study, DreaMS (Drug Research EvaluAtion for Multiple Sclerosis) is on-going for the treatment of multiple sclerosis. The drug keeps lymphocytes in lymph nodes and thereby inhibits the infiltration of lymphocytes into lesions. The compound is therefore expected to be a drug for the treatment of auto-immune diseases such as multiple sclerosis, which is regarded as an intractable disease.
Disease: multiple sclerosis
Details: * On October 3, 2011, Ono Pharmaceutical has signed an agreement with Merck KGaA to out-license ONO-4641, a novel compound originally discovered and developed by Ono for the treatment of multiple sclerosis. Ono granted Merck an exclusive license for development and commercialization of ONO-4641 in countries around the world except Japan, Korea and Taiwan.
Financial terms: Under the terms of the agreement, Ono will receive 1.5 billion yen as an upfront payment. In addition, Ono will also receive milestone payments based on development stage as well as sales-based ones upon achievement of projected sales of ONO-4641.
Latest news: * On June 17, 2014, Merck announced that it has reached a mutual agreement with Ono Pharmaceutical to terminate the license agreement on ceralifimod (ONO-4641) because it does not meet Merck’s threshold for continued investment. Merck obtained worldwide exclusive license rights from Ono Pharmaceutical for the development and commercialization of ceralifimod (ONO-4641) in multiple sclerosis (MS) outside of Japan, Korea and Taiwan in October 2011. The drug candidate is currently in clinical development (Phase II).
