Alzheimer's 'grand slam' for Biogen and Eisai: five things to know

[Froggy]

https://asia.nikkei.com/Business/Ph...=1&pub_date=20210608190000&seq_num=7&si=44594

Alzheimer's 'grand slam' for Biogen and Eisai: five things to know
Treatment for dementia still faces financial and regulatory hurdles

An estimated 6 million people in Japan are suffering dementia, or 17% of the senior population. Eisai filed for approval to use aducanumab in Japan in December. (Source photos by Ken Kobayashi and Kosaku Mimura)
MITSURU OBE, Nikkei staff writerJune 8, 2021 18:15 JST

TOKYO -- U.S. regulators' approval on Monday of aducanumab, an Alzheimer's treatment jointly developed by California-based Biogen and Tokyo-based Eisai, is potentially a life-changing moment for millions.

This is the first time that the U.S. Food and Drug Administration has approved a drug designed to slow the progress of Alzheimer's in sufferers. Previous drugs targeting the disease have aimed only to alleviate symptoms.

It has raised hopes that dementia, a pressing challenge in countries with aging populations, can better be dealt with. In Japan, an estimated 6 million people are suffering dementia, or 17% of the senior population. Alzheimer's is the most common form of dementia, accounting for nearly 70% of cases.

But approval of aducanumab has also been contentious. Is the treatment going to wipe out the disease? How does it work? Here are five things to know.

How does aducanumab work?

Alzheimer's is a disease that causes memory loss and makes it difficult to carry out daily activities or even to speak. The exact cause is unknown, but scientists believe that a protein called beta amyloid is a major cause. As amyloid increases in the brain, it starts forming fibers and then plaques, damaging nerve cells and causing them to die, according to Eisai.

Aducanumab is a monoclonal antibody that targets amyloid, allowing the body to reduce it in the brain. The human body is capable of removing amyloid, but the ability declines with age, Eisai says.

The drug is found to be effective especially when it is used for early-stage patients, according to Eisai, so it is important that the disease is detected early.

Will it eliminate Alzheimer's?

This is the big question. The FDA gave aducanumab an accelerated approval, meaning that Biogen will still need to prove the drug's effectiveness in a post-market study. This is because the results of the earlier trials were not as compelling as the drugmakers hoped them to be -- one of the reasons why approval for the drug was in doubt.

Under the scheme, patients will be allowed to use the drug even though there is still residual uncertainty regarding its efficacy. The approval can be withdrawn if it fails to show its effectiveness in a post-market study.

Price could also be a hurdle for broad adoption. Biogen said on Monday that the drug's list price would be $56,000 a year for an average U.S. patient. The high price tag is likely to limit the users of the drug to those who have an insurance policy that can cover such expensive drugs in the U.S.

In Japan, the drug, if approved, would be covered by the national health care insurance. Given the tight fiscal situation of the Japanese government, access to the drug could be limited to those who are found to have a high level of amyloid, for instance, a drug analyst at a Japanese brokerage house said.

For that, the patient needs to receive a brain scan, but such equipment is not widely available and receiving a test is expensive, the analyst said.

But the analyst expects that demand for the drug will be "very strong."

What has Eisai's role been?

Eisai is a Japanese drugmaker founded in 1941. The current CEO, Haruo Naito, is a grandson of the founder and is known for strong leadership and a top-down management style.

He has made Eisai focus on two areas, Alzheimer's disease and cancer. Under his leadership, Eisai has emerged as a strong developer of innovative drugs.

The company has developed Aricept, a treatment of Alzheimer's disease symptoms.

Eisai joined Biogen's project to develop aducanumab in 2014. Development was risky and analysts say Eisai would not have pursued such a project without Naito's personal commitment.

How has the market reacted?

The news of the U.S. approval took the market by surprise. Shares of Eisai ended up 19% on Tuesday, the biggest gainer on the Tokyo Stock Exchange's first section. In the U.S., shares in Biogen rose more than 50% at one stage and ended the day up 38% at their highest level in six years.

The steep rises reflect the degree of uncertainty over whether the drug would receive U.S. approval.

"It was like hitting a grand slam in the back of the ninth inning," the Japanese analyst said.

What happens next?

Attention will now center on further required regulatory approval for aducanumab in other markets, and on whether other drugs that use similar science can be developed.

Eisai filed in December for separate approval in Japan. "We'd like to make the drug available to Japanese patients as soon as possible," a spokesperson said.

Eisai is also developing, with Biogen, a similar treatment called lecanemab or BAN2401. Lecanemab is also used for removing amyloid at an early stage of Alzheimer's. The company plans to file for approval for lecanemab in the next fiscal year starting in April 2022.

 

[gingerlyn]

I suggest uncles and aunties above 60 to start taking this medication.

 

[Rogue Trader]

Doctors are calling Alzheimer's disease type 3 diabetes because it is caused by high blood sugar and insulin resistance. Fasting is one of the best ways to prevent this mental degeneration (among other health benefits).

Best of all, fasting is completely free. No need to pay pharmaceutical companies and introduce more chemicals into your body.

 

[Froggy]

https://asia.nikkei.com/Business/Ph...=1&pub_date=20210608190000&seq_num=4&si=44594

Biogen and Eisai's dementia drug tie-up pays off with US approval
New treatment holds promise for Alzheimer's patients but obstacles remain

Biogen and Eisai's drug Aducanumab has been shown in clinical trials to be effective in removing amyloid beta plaques in the brain associated with Alzheimer's disease. (Source photo by Biogen/AP)
KENYA AKAMA, Nikkei staff writerJune 8, 2021 14:36 JST

TOKYO -- A pharmaceutical alliance between Japan's Eisai and U.S.-based Biogen has succeeded in developing the world's first therapeutic drug approved for slowing the onset of Alzheimer's disease.

On June 7, the U.S. Food and Drug Administration approved Aducanumab, a new drug developed by the two companies. Until now, there have been no drugs that can suppress the progression of dementia symptoms and this drug, the first new Alzheimer's treatment approved in the U.S. in 18 years, faced a bumpy road to get to this point.

Commercialization of the new drug will provide a big growth boost for both companies, which invested heavily in developing treatments for dementia.

Biogen had been working on Aducanumab since 2007 and Eisai joined the project a decade later to conduct joint clinical trials. The drug is aimed at patients in the early stages of Alzheimer's disease. It is effective in removing amyloid beta, which accumulates in the brain and is considered a disease-causing substance. The new drug also prevents the destruction of nerve cells.

Biogen's share price skyrocketed on news of the FDA approval, rising 64% at one point from last weekend before ending Monday 38% higher on the Nasdaq exchange.

"The approval of [Aducanumab] represents a crucial inflection point in our collective battle against Alzheimer's disease," said Biogen CEO Michel Vounatsos in a statement. "By addressing a defining pathology of the disease, this novel therapy has the potential to help fundamentally change the way patients are diagnosed and treated."

The approval process was not straightforward. Clinical trials, the basis for the approval decision, were split regarding the drug's efficacy. In one trial that involved about 1,600 patients in the early stages of Alzheimer's disease, patients given the drug for a year and a half showed about 20% less cognitive decline than those who did not receive the drug.

However, other trials failed to show any effect and development was temporarily halted in 2019. Later, a reanalysis of the data confirmed the drug's efficacy and development started again.

Even after Biogen submitted its application for approval to the FDA in July 2020, many members of the advisory committee expressed opposition. In addition, the FDA's target date for completing its review -- originally March 2021 -- was pushed back by three months to allow for the verification of additional data submitted by Biogen.

The FDA said Aducanumab "was clearly shown in all trials to substantially reduce amyloid beta plaques," and that "the evidence presented in the [Aducanumab] application met the standard for Accelerated Approval."

Because the drug has been designated for accelerated approval, a separate validation study will need to be conducted after it has gone on the market. The FDA said that if "the confirmatory trial does not verify the drug's anticipated clinical benefit, FDA has regulatory procedures in place that could lead to removing the drug from the market."

Alfred Sandrock, head of development at Biogen, said in an interview with Nikkei that the company respects the views of the advisory committee members, but he believed the FDA had decided that the benefits of the new drug outweigh the risks.

Even the conditional commercialization of the new drug is significant for both Biogen and Eisai. Eisai has been focusing on dementia since 1983, and has invested in the development of drugs like Aricept in 1997. The company has "invested an amount comparable to the mega-pharmaceuticals," according to Eisai CEO Haruo Naito.

Biogen has also focused on neurological diseases, particularly Alzheimer's disease.

At its peak, Aricept had annual sales of 300 billion yen ($2.74 billion at current exchange rates), underpinning Eisai's revenue. However, although the drug temporarily improves cognitive function, it loses its effectiveness after eight to 18 months and can no longer be administered.

Aducanumab, however, directly affects the causative agent, and can thus curb the worsening of symptoms over the long term.

Eisai, which has been investing aggressively with limited resources, is expected to profit significantly from the new drug's approval. The company filed for approval of Aducanumab in Japan in December 2020, and the process is expected to go smoothly now that the FDA has given the green light. Another Alzheimer's Eisai drug, Lecanemab, is in the final stages of clinical trials, and the company plans to apply for approval as soon as fiscal 2023.

Eisai is trying to expand its business to peripheral dementia treatment services, aiming to build a portfolio of products and services ranging from prevention to diagnosis and treatment.

However, Aducanumab still faces one more obstacle: pricing.

Aducanumab is a biopharmaceutical that uses antibodies -- the proteins that form the basis of human immunity. Biopharmaceuticals tend to be more expensive than conventional drugs, which are produced through chemical synthesis. There are concerns that such drugs will prove prohibitively expensive for health care systems.

Biogen announced on June 7 that the annual treatment cost of the drug would be $56,000. The intravenous treatment, which is given every four weeks, costs $4,312 per dose for a patient weighing 74 kg, the average weight of dementia patients in the U.S.

Biogen's Vounatsos said in an interview with CNBC that he believes the price is fair. Biogen and Eisai also issued a statement saying they would not raise the price of the drug for four years.

According to the World Health Organization, there are an estimated 50 million dementia patients globally, of which 60% to 70% have Alzheimer's disease. Some experts estimate the number will triple to 150 million by 2050.

The question for Eisai, which is "prepared to live and die with dementia [treatments]" according to Naito, is how it can link critical therapeutic drugs to peripheral services like prevention and diagnosis.