Biogen (NASDAQ: BIIB) announced today that it has increased the profit potential on aducanumab, its Phase 3 investigational treatment for early Alzheimer’s disease, by reducing the potential royalty payment on potential commercial sales of aducanumab to Neurimmune Holding AG. In exchange for a 15 percent reduction in the previously negotiated royalty rates, Biogen agreed to make a one-time $150 million payment to Neurimmune Holding AG.
Biogen licensed the worldwide rights to aducanumab from Neurimmune Holding AG in 2007 and is responsible for its development and the commercialization.
“This amended agreement with Neurimmune improves aducanumab’s potential value to Biogen as we pursue our strategic goal of leadership in Alzheimer’s disease,” said Michel Vounatsos, chief executive officer of Biogen. “We are pleased with our ongoing collaboration with Neurimmune in Alzheimer’s and other neurodegenerative disorders.”
As part of this amended agreement, Biogen also has an option to further reduce the royalty owed on potential commercial sales of aducanumab by an additional 5 percent in exchange for an additional one-time $50 million payment to Neurimmune Holding AG.
Aducanumab (BIIB037) is an investigational compound being developed for the treatment of early 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.
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. Founded in 1978 as one of the world’s first global biotechnology companies by Charles Weissman and Nobel Prize winners Walter Gilbert and Phillip Sharp, today Biogen 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, neuroimmunology, movement disorders, neuromuscular disorders, pain, ophthalmology, neuropsychiatry, and acute neurology. Biogen also manufactures and commercializes biosimilars of advanced biologics. We routinely post information that may be important to investors on our website at www.biogen.com. To learn more, please visit www.biogen.com and follow us on social media – Twitter, LinkedIn, Facebook, YouTube.
Biogen Safe Harbor Statement
This press release contains forward-looking statements, including statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including statements relating to the anticipated benefits and potential of our collaboration agreement with Neurimmune and the potential of our commercial business and pipeline programs, including aducanumab. These forward-looking statements may be accompanied by words such as “aim,” “anticipate, “believe,” “could,” “estimate,” “expect,” “forecast,” “intend,” “may,” “plan,” “potential,” “possible,” “will”, and other words and terms of similar meaning. Drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product. Results in early stage clinical trials may not be indicative of full results or results from later stage or larger scale clinical trials and do not ensure regulatory approval. You should not place undue reliance on these statements.
These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements, including without limitation, uncertainty as to whether the anticipated benefits and potential of our collaboration agreement with Neurimmune can be achieved; risks of unexpected costs or delays; uncertainty of success in the development and potential commercialization of aducanumab, which may be impacted by, among other things, unexpected concerns that may arise from additional data or analysis, the occurrence of adverse safety events, failure to obtain regulatory approvals in certain jurisdictions, failure to protect and enforce our data, intellectual property, and other proprietary rights and uncertainties relating to intellectual property claims and challenges; and third party collaboration risks. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from our expectations in any forward-looking statement. Investors should consider this cautionary statement, as well as the risk factors identified in in Biogen’s most recent annual or quarterly report and in other reports Biogen has filed with the Securities and Exchange Commission. These statements are based on our current beliefs and expectations and speak only as of the date of this press release. We do not undertake any obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise.