Merck KGaA has decided to hand back rights to an orally-active drug in phase II trials for multiple sclerosis (MS) to partner Ono Pharmaceutical.
The German pharma company said in a statement that ceralifimod (ONO-4641) “does not meet Merck’s threshold for continued investment”.
The decision has come as something of a surprise, because as recently as April Merck was highlighting ceralifimod as one of the standout candidates within its neurodegenerative R&D programme.
At this year’s American Academy of Neurology meeting, for example, the company presented results of a phase II trial called DreaMS which indicated that the drug was effective in reducing the number of new and enlarging lesions in the brain as measured by magnetic resonance imaging (MRI).
Ceralifimod is a sphingosine-1-phosphate (S1P) receptor-1 and -5 agonist and was licensed by Merck in 2011 for development outside Japan, Korea and Taiwan. The German company had been looking for additional pipeline candidates to bolster its MS franchise, currently led by $2.4bn-a-year blockbuster Rebif (interferon beta-1a).
Like other interferon drugs, Rebif is facing growing competition from a new generation of orally-active MS drugs such as Biogen Idec’s Tecfidera (dimethyl fumarate) and Novartis’ S1P agonist Gilenya (fingolimod).
The demise of ceralifimod leaves a big hole in Merck’s pipeline with no orally-active drug in the offing to round out its franchise and the decision comes after the company was forced to abandon its cladribine candidate in 2012.
Merck said in a statement that it “remains committed to improving the lives of people with MS, and will continue to pursue external collaborations and internal development programmes aimed at identifying and developing high quality candidate molecules”.
The German company’s clinical pipeline of new MS drugs now consists of plovamer acetate (PI-2301), a second-generation drug in the same class as Teva’s blockbuster Copaxone (glatiramer acetate) that has reached phase II trials, and immune-tolerising agent ATX-MS-1467 in phase I.
It also has a licensing deal in place for Tcelna (imilecleucel-T), a personalised treatment for secondary-progressive MS developed by Opexa Therapeutics that is in phase IIb testing with top-line data expected in 2016.