Biogen Stops Clinical Trials of Its Long Hoped-for AD Treatment

The global pharmaceutical industry was disappointed when U.S. pharmaceutical company Biogen announced on March 21 that it would stop the Phase 3 clinical trial of Alzheimer's disease (AD) treatment Aducanumab, which it has been co-developing with Japan's Eisai.

The industry expected that Aducanumab was going to be a new savior after big global pharmaceutical companies have failed to develop a new dementia treatment.

Global demand for a dementia treatment is growing rapidly due to population aging. Yet large-scale global pharmaceutical companies have continued to fail in their efforts to develop new dementia drugs. The inability of global pharmaceutical companies to develop a dementia treatment is also discouraging domestic pharmaceutical companies.

According to the Alzheimer's Association International (ADI) on April 4, the global dementia treatment market is expected to grow four times from 350 billion won (US$3.07 billion) in 2015 to 13.5 trillion won (US$11.86 billion) in 2024. This is because the entire world is entering the era of population aging and the number of people with dementia will increase rapidly.

The global pharmaceutical industry hoped that Biogen's Aducanumab will be the key to unraveling the secrets of dementia treatment. In early clinical trials, Aducanumab not only eliminated the beta amyloid plaque, a toxic protein on the surface of the neurons in the brain that is thought to be the main cause of dementia, but also improved cognitive function in patients with dementia. Previously, well-known pharmaceutical companies including Merck, Eli-Lilly, AstraZeneca and Johnson & Johnson have all tried to develop dementia drugs targeting beta amyloid, but all have failed in the clinical trial stage. In January, Swiss pharmaceutical company Roche also stopped the Phase 3 clinical trials of beta amyloid-targeting treatment Crenezumab

Experts say that AD patients are at variance in their genetic characteristics and clinical course, making it difficult to develop therapeutic drugs that target proper symptoms. It is impossible to know the exact cause of the disease. "So far, global study of dementia has targeted beta amyloids that kill neurons and impair cognitive function," a pharmaceutical industry official said. "But it is clear that the cause of dementia is not even clear."

The development of dementia drugs in Korea is also slow. Domestic pharmaceutical companies started out using natural ingredients, such as jujube and angelica, instead of biopharmaceuticals, but they are still in the initial phase. According to the Ministry of Food and Drug Safety, the number of new cases of dementia treatment for the past five years has increased from 10 in 2014 to 13 in 2015, but dropped to three last year. Out of the three cases, two were done by global company Roche, and Mediforum was the only domestic company.