Biogen and Neurimmune announced that Biogen has exercised its option to further reduce the previously negotiated royalty rates payable on potential future sales of aducanumab, Biogen’s Phase 3 investigational treatment for early Alzheimer’s disease.
Biogen will make a one-time $50 million payment to Neurimmune in exchange for a 5% reduction in the original royalty rates on potential commercial sales of aducanumab, which follows the 15% reduction in royalty rates announced in October 2017. The reduced royalty rates on potential commercial sales of aducanumab will be in the high single digits to low-teens. Biogen licensed the worldwide rights to aducanumab from Neurimmune in 2007.
“Biogen values our collaboration with Neurimmune, and this step is aligned with our amended agreement from 2017,” said Michel Vounatsos, chief executive officer of Biogen. “As we progress our pipeline of candidates for Alzheimer’s disease including aducanumab, we hope that a potential treatment for this devastating and debilitating disease will be realized.”
“At Neurimmune, we are pleased with the continuous progress of our long-term successful collaboration with Biogen”, said Roger Nitsch, chief executive officer of Neurimmune. “This non-dilutive financing supports our growth strategy focused on bringing human-derived antibodies through clinical proof-of-concept in disease areas with high medical need.”
Aducanumab (BIIB037) is an investigational compound being developed for the treatment of Alzheimer’s disease. Aducanumab is a human recombinant monoclonal antibody (mAb) derived from a de-identified library of B cells collected from healthy elderly subjects with no signs of cognitive impairment or cognitively impaired elderly subjects with unusually slow cognitive decline using Neurimmune’s technology platform called Reverse Translational Medicine (RTM). Biogen licensed aducanumab from Neurimmune under a collaborative development and license agreement.
Aducanumab is thought to target aggregated forms of beta amyloid including soluble oligomers and insoluble fibrils which can form into amyloid plaque in the brain of Alzheimer’s disease patients. Based on pre-clinical and Phase 1b data to date, treatment with aducanumab has been shown to reduce amyloid plaque levels.
In August 2016 aducanumab was accepted into the European Medicines Agency’s PRIME program. In September 2016 the U.S. Food and Drug Administration accepted aducanumab into its Fast Track program and in April 2017 aducanumab was accepted into the Japanese Ministry of Health, Labour and Welfare’s (MHLW) Sakigake Designation System.
As of October 2017, Biogen and Eisai entered into a global collaboration agreement to jointly develop and commercialize aducanumab.
At Biogen, our mission is clear: we are pioneers in neuroscience. Biogen discovers, develops, and delivers worldwide innovative therapies for people living with serious neurological and neurodegenerative diseases. One of the world’s first global biotechnology companies, Biogen was founded in 1978 by Charles Weissmann, Heinz Schaller, Kenneth Murray, and Nobel Prize winners Walter Gilbert and Phillip Sharp, and today has the leading portfolio of medicines to treat multiple sclerosis; has introduced the first and only approved treatment for spinal muscular atrophy; and is focused on advancing neuroscience research programs in Alzheimer’s disease and dementia, multiple sclerosis and neuroimmunology, movement disorders, neuromuscular disorders, pain, ophthalmology, neuropsychiatry, and acute neurology. Biogen also manufactures and commercializes biosimilars of advanced biologics.
Neurimmune is a biopharmaceutical company dedicated to the development of human-derived therapeutic antibodies for the treatment and prevention of human diseases with a high unmet medical need. Established in 2006, Neurimmune has rapidly grown into a leader in the field of recombinant human monoclonal antibody therapeutics. Neurimmune’s pipeline comprises high-potential drug candidates at both clinical and advanced preclinical development stages. Aducanumab, an investigational treatment for Alzheimer’s disease, partnered with Biogen, is currently in phase 3 clinical trials. Rights in antibodies BIIB054 for Parkinson’s disease and BIIB076 for Alzheimer’s disease were acquired by Biogen. In 2016, Neurimmune partnered with TVM and Eli Lilly’s Chorus unit to advance an antibody for the treatment of amyotrophic lateral sclerosis. In 2017, Neurimmune entered into a collaboration with Ono Pharmaceutical in Japan. Neurimmune’s pipeline includes human antibody programs for cardiomyopathy, type-2 diabetes and progressive multifocal leukoencephalopathy, with potential therapies in advanced preclinical stages.