- For the second time within a year, Biogen has opted to cut the royalty rates that it will pay out to aducanumab's developer, Neurimmune, in return for a one-time payment of $50 million.
- The royalty rate for the potential Alzheimer's disease drug will fall by 5%, following a prior reduction of 15% in October 2017. The royalties will now be in the range of high single digits to low-teens.
- Aducanumab is closely watched, with high expectations. It has been accepted into the European Medicines Agency's PRIME program, the Food and Drug Administration's fast track program, and the Japanese Ministry of Health, Labour and Welfare’s sakigake designation system.
The route to developing a successful drug for Alzheimer's disease has been littered with failures, some very costly. Between 2002 and 2012, only one of 244 clinical-stage compounds reached the market, and there are still no disease-modifying drugs. This is, at least in part, because the root cause of the disease and its pathway still isn't fully defined, and studies to prove success need to be long-term and large. Some of the most dramatic failures were Eli Lilly's solanezumab, Merck & Co.'s verubecestat, and more recently vTv Therapeutics' azeliragon.
With the ongoing development of aducanumab, both Biogen and the industry at-large are holding out hope for the potential approval of a disease-modifying drug. Results from a Phase 1b trial suggested that the agent could reduce the accumulation of amyloid plaque and even slow cognitive decline. Aducanumab is now in Phase 3, and the company has increased enrollment in two studies, due to "variability" on the primary endpoint.
Aducanumab was discovered by Neurimmune and licensed to Biogen in 2007. The deal included options to reduce royalties to Neurimmune in return for payments. The first of these was exercised in October 2017, when Biogen put down $150 million to reduce Neurimmune's royalties by 15%. This and Tuesday's 5% deal support Biogen's confidence in the drug's potential market, which could reach $1.5 billion in 2022, according to EvaluatePharma market intelligence.
"Biogen values our collaboration with Neurimmune, and this step is aligned with our amended agreement from 2017," said Michel Vounatsos, CEO of Biogen, in a statement. "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."
The non-dilutive financing that the deal provides for Neurimmune will support its aim to bring human-derived antibodies through clinical proof-of-concept studies in disease areas with high medical need, Roger Nitsch, CEO of Neurimmune, said in a statement.
In March 2014, Biogen and Eisai signed an agreement to develop and commercialize Alzheimer's disease treatments, which provided Eisai with an option to license aducanumab, then known as BIIB037. Eisai opted into the agreement in October 2017, giving it a dominant share of potential profits from the drug in Asian territories. One of the other drugs in the original agreement, BAN2401, missed its primary endpoint in Phase 2 late in 2017.