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Biogen: Application for approval of Alzheimer's drugs



Experts see opportunities for drug approval - in pictures of housing groups for dementia patients in Aargau. (Image: Annick Ramp / NZZ)

Experts see opportunities for drug approval – in pictures of housing groups for dementia patients in Aargau. (Image: Annick Ramp / NZZ)

This week, the US biotech giant, Biogen, was surprised by the application for approval of the Alzheimer's drug. Michel Vounatsos, CEO of the company, commented on the surprising study results and Swiss location.

Werner Grundlehner

Biogen's announcement this week surprised the stock and science markets. The US biotech giant wants to file in early 2020 in the US application for approval for the Alzheimer's drug Aducanumab. Until March, following a provisional analysis that could not provide proof of efficacy, the company stopped the approval study for this application. As a result, Biogen lost $ 18 billion – almost one third of the stock market value.

This saddle is now used. Change of mind is based on a new analysis of a larger dataset, which takes into account more study participants over a longer period of time. According to Biogen, a higher dose and a longer duration of treatment result in a statistically significant improvement for Alzheimer's patients.

Forward to Neuroscience

"We are also surprised," Biogen CEO Michel Vounatsos said. The company needed several weeks and close collaboration with the FDA to find out why the results were different in the new analysis. How long the approval process will take and even if the accelerated procedure is possible, Vounatsos has not been able to estimate.

The failure of Aducanumab will not change Biogen's strategy, according to Vounatsos: "Since joining the company three and a half years ago as CEO, I have tried to make Biogen a market leader in neuroscience." medical needs.

Buoyancy for the Antibody approach

With the new results, the Biogen Antibody Strategy is also gaining momentum. Aducanumab targets the dissolution of protein clots (beta amyloid protein) in the brain. After the decision in March, this approach, which was followed by many other companies, seems to be at the end. "Recent success stories with theses about amyloid increase confidence that our antibody strategy also applies to other neuroleids," Vounatsos said confidently.

Although improvements for Alzheimer's patients in the opinion of individual experts in everyday life are only minimal, there is a possibility for market approval – also because scientists are desperate. Over the past twenty years, research has only declined. More than one hundred clinical studies so far have not provided effective treatment for rapidly developing dementia. Many pharmaceutical companies reject Alzheimer's research. Alzheimer's is a disease that is so complex and heterogeneous that there are many hypotheses and research approaches on how to overcome it.

MS as an example of development

Vounatsos believes that Biogen can show that the risk in Alzheimer's research is beneficial. He uses the example of multiple sclerosis: "Even in this field of application, there have only been setbacks and failures for years – until the first drug was approved. Today there are fifteen applications approved for MS.»

Biogen has a close relationship with Switzerland. The construction of a production facility in Luterbach near Solothurn with work for 600 employees and a cost of $ 1.5 billion is likely to be one of the biggest industrial investment projects in recent years in Switzerland. According to Vounatsos, this fully automated biopharmaceutical plant can be used flexibly and will be able to produce products from the entire Biogen portfolio, which are then exported worldwide. The Aducanumab approval has no influence on the completion of the production location. At Luterbach production must begin in 2020.

Punitive Customs on pharmaceutical products?

When asked if he was worried about import duties for pharmaceutical exports from Switzerland to the US, Biogen's CEO replied: "I haven't heard anything about it, there are currently a lot of rumors and suggestions – so far we don't know." Recently , information sources want to know that the US is considering such a move because of high trade deficits. The United States will continue to support drug discovery and innovation, according to Vounatsos.

Biogen was founded in 1978 in Geneva, and two founding members later received the Nobel Prize in chemistry and medicine. In 1982, the company's headquarters moved to Cambridge, Massachusetts. At present, the Group's international activities are managed from Zug, where 400 employees are active. The Alzheimer Aducanumab drug, whose research data is fun published this week, has been developed by Neurimmune in Schlieren and is licensed to Biogen.

Tinkerer is a pharmacist

The roots of the Biogen Tecfidera blockbuster for the treatment of MS are also in Switzerland. Pharmacist Hans-Peter Strebel discovered the molecule and sold it in 2006 for CHF 220 million to Biogen. Strebel remains involved in the successful sales of Tecfidera. The drug generated $ 4.3 billion in sales last year. Biogen currently has three other blockbuster applications, generating revenues of more than $ 1 billion per year.

Little concern Vounatsos at the discussion about the level of drug prices, which throughout the world, but especially in the US, took the lead. "I am convinced that innovation is supported throughout the world," said the CEO. In the US alone, direct and indirect costs of Alzheimer's are $ 500 billion per year. If Biogen succeeds in slowing down the course of the disease by several years, it will bring huge savings. He also said yes, not patients suffering from Alzheimer's, but the whole family. The amount of care required is so large that family members often have to give up a portion of their lives so that the cost of drugs fades into the background. "It's about patients, the environment and the health care system," Vounatsos said.


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