Biogen autoimmune news

In its 3Q earnings, Biogen said it plans to eliminate some pipeline programs and cut 11% of its 8,000-employee workforce to push higher priority candidates through the clinic and boost marketing efforts for multiple sclerosis drug Tecfidera dimethyl fumarate. The company terminated development of both Tysabri natalizumab and Tecfidera to treat secondary progressive MS. Biogen also said Tysabri missed its primary and secondary endpoints in the Phase III ASCEND trial to treat secondary progressive MS. Tecfidera was in the Phase III INSPIRE trial for the indication.

Biogen also ended its anti- TNF-like weak inducer of apoptosis (TWEAK) program, BIIB023, to treat lupus nephritis after a Phase II futility analysis. Furthermore, the company discontinued some immunology and fibrosis research activities; Biogen declined to disclose specific programs. The company expects the restructuring to reduce annual operating expenses by $250 million. It said the savings would give it flexibility to focus on pipeline programs including Phase III Alzheimer’s disease candidate aducanumab ( BIIB037), Phase II AD candidates BAN2401 and E2609, Phase II MS candidate BIIB033 and Phase III spinal muscular atrophy (SMA) therapy ISIS-SMNRx. The company expects data next year from the five programs. Eisai Co. Ltd. (Tokyo:4523, Tokyo, Japan) is partnered with Biogen to co-develop and co-commercialize BAN240, a humanized conformational specific IgG1 mAb targeting the toxic beta amyloid protofibrils, and E2609, a beta-site APP-cleaving enzyme (BACE) inhibitor. Biogen has rights to develop and commercialize aducanumab, a human recombinant anti-beta amyloid mAb, from Neurimmune Holding AG (Schlieren, Switzerland), and Eisai has option to co-develop and co-commercialize the product. Biogen has an option to license ISIS-SMNRx, an antisense oligonucleotide that modulates splicing of survival of motor neuron 2 centromeric (SMN2) mRNA, from Isis Pharmaceuticals Inc. (NASDAQ:ISIS, Carlsbad, Calif.) at the completion of either the first successful Phase II/III trial or the completion of two Phase II/III trials. ...