The pre -market skyrocketed $ 15.3 billion, and the "warfire" of Alzheimer's drugs that were ignited again

The pre -market skyrocketed $ 15.3 billion, and the "warfire" of Alzheimer's drugs that were ignited again

Source: amino observation/Fang Taozhi

Alzheimer's disease is perhaps the most obsessed with the research and development field of global pharmaceutical companies.

A report released by the American Pharmaceutical Production and R & D Association in 2018 shows that from 2000 to 2017, the cumulative research and development costs of pharmaceutical factories have exceeded 600 billion U.S. dollars.

The enlisted people are not only the obscure Biotechs, but also the global pharmaceutical factories such as Lilly and Pfizer. Obviously, the pharmaceutical factories are seriously developed for the treatment of Alzheimer's disease.

But unfortunately, 99.99999%of pharmaceutical companies have eaten.

Since the 1990s, the FDA has only approved 6 Alzheimer's drugs to go public, of which only 4 were approved after 2000. These drugs that have been approved to be listed can only delay the occurrence of symptoms and have limited efficacy.

What is disappointing recently is Biogen's Aduhelm. In 2021, Biogen Alzheimer's treatment drug ADUHELM was listed, but was defeated by questioning and pricing.

Biogen has also fallen into the need for layoffs to maintain their livelihood. At the same time, the entire Alzheimer Circuit also cooled with Biogen's ADUHELM.

However, this cooling period has not lasted too long. On September 27, Biogen / Wei Materials jointly announced that Alzheimer's Drug LECANEMAB has reached all the main clinical end and secondary endpoints, which can significantly improve patient cognition.

Affected by the news, Biogen's stock price increased by more than 54%, and the market value increased by more than $ 15 billion.

The huge wealth effect means that the anti -R & D fire of Alzheimer's drug will be ignited again.

01

Statistical efficacy efficacy

One of the important reasons for the clinical data released by Lecanemab has attracted market attention.

As mentioned above, the difficulty of R & D in Alzheimer's drugs can be called a hell model, and the failure rate of pharmaceutical companies in this field is as high as 99.9%.

It is not difficult to understand. Today, Alzheimer's disease is still one of the most difficult diseases in the world. The medical community still knows very little about its onset principle. There are currently two mainstream hypothesis about the occurrence mechanism of Alzheimer's disease:

First, the Aβ hypothesis, that is, β-starch-like protein (Aβ) excessively expresses the gathers into starch-like plaques; the second is that the Tau protein hypothesis, that is, the nerve fiber tangue formed by the folding of tau protein over-folded after excessive phosphate.

Regardless of the hypothesis, countless pharmaceutical companies have frequently folded halberds. The most recognized Aβ hypothesis of the pharmaceutical company made Biogen suffer.

The ADUHELM mentioned above is the first Aldzheimer's disease that has been approved by the FDA in the past two decades, which has made Biogen's unlimited scenery.

However, Aduhelm failed to become a new Biogen growth engine, but became a "dragging oil bottle", and finally withdrew from the market in April this year.

The core cause of Aduhelm's bleak performance is that the efficacy is unknown, and the drug does not have much improvement in patients.

This also led to the hot development of Alzheimer's disease, which was briefly ignited, and entered a cooling period. It is in this context that LecaneMab was born.

Although it is also a drug that targets β-starch-like proteins, the role of LecaneMab and ADuhelm is completely different, which also brings better results.

Specifically, the main end of the clinical trial of LecaneMab is the global cognitive and functional scale CDR-SB.

CDR-SB is the reference standard for the results of Alzheimer's disease-related test results. It mainly measures cognitive functions and memory functions. The total score is 0-18 points. The higher the score, the worse the patient's cognitive function and daily life ability.

In this clinic, the CDR-SB score of patients decreased by 27%compared with placebo. Specific to scores, in the analysis of the treatment of crowds, the score of treatment changes to -0.45 (p = 0.00005).

According to Gregory Jicha, chief researcher at the LECANEMAB Clinical Research Center at the University of Kentucky, CDR-SB is close to 30%, which is equivalent to slowing the patient's disease state for about 8 months.

The more P value, the more statistically it is. Obviously, LECANEMAB does have clinical improvement.

In addition, this clinical trial selected four sub-clinical end points, starch-like positive electron emission fault scan (PET), and ADAS-COG14, ADCOMS, ADCS-Adl-MCI. Also succeed.

Whether it is the main end or secondary end point, LecaneMab shows good improvement data, which will naturally make the market full of expectations.

On September 27, Biogen and Wei Materials jointly announced that they will apply for LECANEMAB listing in many countries and regions such as the United States, Japan, Europe and other countries.

Perhaps LecaneMab will make Biogen regain his face.

02

Do you really hope or empty joy?

Of course, given the difficulty of hell -level R & D in Alzheimer's disease, we should still maintain rationality in the future of LecaneMab. LECANEMAB seems to have a significant effect, in fact, there are "variables". Because the conclusion with a significant effect is based on the "improvement ratio". As mentioned above:

LECANEMAB can reduce the patient's ability to know 27%.

But then again, in the field of statistics, the proportion of discounting the base is hooligan. After all, when the base is extremely small, the data changes slightly will cause a great fluctuation.

The third phase of LECANEMAB's clinical data is the same. As mentioned above, compared with the placebo group "

The CDR-SB score of the LecaneMAB treatment group has only dropped by 0.45 points.

The total score of this scale is 18 points. In contrast, the improvement of 0.45 points is not particularly obvious. Because of this, some people in the market said whether the reconstruction of 0.45 points is worth further discussion.

At the same time, the side effects of the LECANEMAB treatment group are not low.

Among the patients using LecaneMab, starch-related imaging abnormalities (ARIA) appeared from 21.3%. The specific manifestations were cerebral edema (aria-e) or cerebral hemorrhage (ARIA-H), and patients using placebo were using placebo. This adverse reaction is only 9.3%.

Although ARIA does not cause any symptoms, there are also some patients with blurring and falling. Even patients with 1%to 2%need to be hospitalized or suffer from long -term damage to the cerebral edema, cerebral hemorrhage, and epileptic seizures.

In the clinical trials of Aduhelm for Alzheimer's patients, 6%of patients with high dose group terminated clinical trials due to imaging abnormal side effects. Obviously, LecaneMab's security issues can cause patients' attention.

More importantly, the price of innovative drugs is never low. Take Aduhelm, although its curative effect is controversial, it has not affected its high pricing.

Aduhelm's dose is dossed by weight. A patient with an average weight of 75 kg has a annual treatment cost of $ 56,000.

Without reimbursement, the treatment fee of $ 56,000 per year is also a large amount of expenses for most American people. The clinical data is even better, and the price will not be cheaper in terms of price.

Limited curative effects, high side effects, superimposed treatment prices, and how LECANEMAB can perform at the commercialization level, it has to be given the answer.

03

Alzheimer's Drug Research and Development, which was ignited again

But anyway, LecaneMab's success is still enough to inspire the market. After Biogen and Wei Materials announced this data, the stock price of BIOGEN rose more than 50%before the market.

Biogen, which was once relentlessly abandoned by the capital market, has now become a new favorite, which fully illustrates the attractive part of Alzheimer's drugs.

Indeed, behind Alzheimer's drug is a gold mine.

A report released by the "Liu Ye Dao" in 2020 mentioned that about 50 million people in the world suffer from dementia. Based on this calculation, there are about 25 million to 35 million in patients with Alzheimer's disease.

As the aging trend intensifies, the number of new patients will not be too small. Correspondingly, the market of Alzheimer's disease will not be small.

If LECANEMAB is finally approved to be listed, it will inevitably cause the market to develop the R & D boom of Alzheimer's disease. Not only overseas, but also pharmaceutical companies in this field, including Hengrui Pharmaceuticals, will also receive market attention.

However, the former teacher is not forgotten.

On the road to the development of Alzheimer's disease, there are many failure experiences such as Aduhelm, and we are better to maintain rationality.

After all, the road of innovative drugs has never lack of accidents, and the prospects of Alzheimer's drug market still have uncertainty. But a good thing is that the trend is turning.

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