Biogen Idec's hopes of getting approval for its new haemophilia A drug Eloctate soon have been hit by the news that regulators in the USA are requesting further information.
Biogen's partner Swedish Orphan Biovitrum (Sobi) noted comments made by the former at the Credit Suisse Global Healthcare Conference in Phoenix, that the US Food and Drug Administration has requested additional information "pertaining to process validation of certain steps in the manufacturing process" for Eloctate (recombinant factor VIII Fc fusion protein). As a result, Biogen expects a Prescription Drug User Fee Act (PDUFA) date extension.
Sobi says that Biogen is now planning for "a mid-2014 commercial launch in the US based on on-going discussions with the FDA". The Swedish firm added that this delay is "unlikely to impact planned European approval timelines".
Meantime, Biogen has linked up with Belgium's Galapagos to develop treatments for scleroderma.
Galapagos’ service division BioFocus will use its SilenceSelect platform and unique human skin models to deliver new assays "and identify validated, novel, disease-modifying targets in scleroderma" to Biogen. Under the terms of the agreement, BioFocus will receive an upfront payment and various milestones so the total value of the collaboration could reach $31 million.
Jo Viney, vice president of discovery sciences at Biogen, said that "we believe Galapagos has unique expertise with relevant human primary cells, positioning them well to find new targets for disease-modifying therapies against scleroderma". The latter is an autoimmune disease characterised by hardening of the skin and affects one in 1000 people in the USA, with women four times more likely than men to develop the disease.