Eagle Country Biogen is a world-leading biopharmaceutical company that treats Alzheimer's disease and other neurological diseases, with annual sales exceeding 10 billion US dollars. It ranked 20th in last year's ranking of the top 50 global prescription drug companies.
Aduhelm is one of Bogen's flagship drugs.
The drug selectively binds to beta-amyloid proteins in the brain and then activates the immune system to clear amyloid plaques from the brain.
However, the road to the launch of this trump card drug was very bumpy, with many twists and turns, and there were many controversies after it was launched.
When the drug was first applied to the FDA for marketing, it was rejected due to unclear effects. Originally, Bogen was about to abandon the drug. However, in subsequent clinical trials, after expanding the sample and increasing the dosage, positive effects on patients were discovered. highlighted.
So Bogen continued to invest in research and development, reapplied for FDA approval, and received accelerated approval for listing.
The approval was highly controversial within the industry amid strong opposition to the drug approval from FDA advisory committee members. When regulators decided to approve the drug, ten members of the panel resigned.
The safety of aduhemer has been the reason for the drug's ill-fated fate, with one woman who took it dying of cerebral edema. It has not yet been confirmed that her death was caused by the drug, but it has a big impact on doctors' confidence in prescribing it to patients.
Biogen continues to generate data supporting the drug's safety and efficacy in Alzheimer's disease. At the subsequent Alzheimer's disease clinical trial meeting, Biogen announced data from two phase III trials. The results showed that after treatment, patients' amyloid plaques were reduced, and p-tau181 (Alzheimer's disease) was found in plasma. tau markers) were significantly reduced.
It is generally believed that the FDA approved the drug for marketing on the basis that the benefits of the drug for patients with Alzheimer's disease outweigh its risks, which mainly expresses an attitude of encouraging AD drug research.
After all, the current research on new drugs to treat AD has basically been wiped out. No new drugs have been approved in the past ten years or so. This has really dampened the enthusiasm of pharmaceutical companies for research and development. Some pharmaceutical companies have completely given up on research in this area. As society ages, the research and development of drugs to treat AD is very urgent.
The FDA's accelerated approval provides patients with earlier treatment opportunities. At the same time, the FDA also requires Bogen to continue conducting a new randomized controlled clinical trial to further verify the clinical benefits to patients. If follow-up trials go poorly, the FDA could withdraw approval of the drug.
Patients and their families are still waiting eagerly for this. After all, they have been waiting for too long. The last time the FDA approved the Alzheimer's disease drug Namenda (domestic name "Memantine") was in 2003.
However, after the new drug was launched, sales were bleak due to the high price and annual treatment costs of up to US$60,000. Eagle Country officials soon announced that it would be included in the country’s medical insurance, and Biogen took advantage of the situation and lowered the price to US$30,000 per year. Finally, the situation in the market was saved.
However, in addition to the Eagle Country, the drug was also rejected by the drug regulatory authorities of Europa and Sakura Country at the end of last year. Both companies said that they did not have enough data to support their approval of the drug for marketing.
In short, Bogen's stock price often enjoys a roller coaster ride due to news about this drug, which also causes Bogen's CEO to be very sensitive to any related news.
When he saw the news that his own medicine was being compared with Sanqing's AD special medicine, his vision suddenly went dark, and an ominous premonition instantly enveloped him.
At this time, in a hut somewhere in Eagle Country.
Amy Jones was watching the news on TV intently, which was showing detailed clinical data of Sanqing and Biogen's AD specific drugs.
She has brown hair and deep eyes, is tall and has deep crow's feet at the corners of her eyes. She looks to be in her early forties and has a very calm face.
As she looked at it, her eyes suddenly fluctuated. She got up and walked to the computer, and began to search for information about this special medicine on the Internet.
As a patient with familial Alzheimer's disease, both her grandmother and mother had suffered from the disease, and she was very familiar with the disease.
Approximately 1%-5% of AD patients worldwide have a family history of AD, most of whom develop the disease before the age of 60, and many people even begin to experience symptoms in their 40s.
This also leads to greater pain for them, because most common patients only start to develop the disease after the age of 60.
Amy is forty-two years old. According to the experience of her mother's two generations, she knows that she does not have much time left.
After her mother worked hard to take care of her grandmother for many years, she discovered that she had symptoms of the disease again, so she decided to commit suicide rather than drag her daughter down. This gave her great mental stimulation.
Since then, she has lived alone in a small house in the suburbs, quietly waiting for that day to come.
Under her pillow is the gun that took her mother away. If nothing happens, this gun will also take away her life.
Before the disease completely engulfed her brain, she was ready to meet her mother and grandmother at any time.
There is also a Bible under the pillow. Before going to bed every day, she will recite this book silently and then recall the details of the day's life to confirm whether her memory is intact.
This disease is like the sword of Dalimos hanging high above her head, which will fall at any time and harvest her life.
And now, someone in the news actually said that a specific drug that can cure this disease has appeared.
She scoffed at it at first. After all, she had made friends with some patients through this disease, but the feedback they gave after taking various medicines on the market was not very good.
This includes Bogen's special medicine. A patient had a splitting headache after taking this medicine and had to stop taking it to protect himself.
However, this Sanqing special medicine seemed a little different. The more she searched for relevant information, the more frightened she became.
She also saw the paper in the "Nature" magazine, and the therapeutic effects shown above made her excited.
A desire for life slowly emerged in her heart.
Is this disease really curable?
The paper emphasizes that this drug only has great effects on early-stage patients, which is enough for her.
She hasn't gotten sick yet. If she keeps taking this medicine, won't she be able to delay the onset of the disease?
Amy suddenly became energetic and began to pay attention to the special reports on Fox News.
"Results of the second phase of clinical trials show that patients' conditions are improving every week. Positron emission tomography (PET) imaging shows that one month after receiving treatment, 80% of patients tested negative for PET, meaning that they had amyloid in their brains. The level of deposition is no longer significantly different from that of healthy people."
"At the same time, the reduction in IADRS, a combined index that assesses patients' cognitive abilities and daily living abilities, was reduced by 89% compared with the placebo group."
"Patients' amyloid plaque levels dropped by an average of 84 units, compared to a baseline of 108 units (a number less than 25 indicates a negative amyloid plaque scan)."
"1% of the subjects experienced less severe dizziness, nausea, palpitations, allergies and other reactions, and they still need to wait for follow-up clinical observation."
The more she read, the more excited she became. The data from these second-phase clinical trials all showed the powerful efficacy of the Sanqing AD special drug, with very few side effects. Compared with the dangers of cerebral edema, it was nothing.
So I immediately contacted other AD patients and everyone shared the good news.
All the patients in Eagle Country cheered: "God, thank you for allowing Sanqing to create such a miraculous drug. We are finally saved!"
They are preparing to take action to make Sanqing, a special medicine, available in Eagle Country as soon as possible.
At this time, Blanche of Fox News was also facing a huge embarrassment.
The clinical data of the Sanqing AD specific drug is so good that it is beyond anyone’s expectation, causing all the authoritative experts to be dumbfounded. Not only does the efficacy of the drug beat Bogen’s drug instantly, but it also outperforms the competition in terms of side effects. The opponent is far behind.
Alzheimer's disease is finally cured!
This magical effect led to a surge in traffic, and even passers-by who had never heard of the disease were attracted by the gimmick.
But the more people read about it, the more famous the name of Sanqing Special Drug became. More and more experts were persuaded and began to praise this drug.
This is not the effect Blanche wants at all. He wants experts to criticize this medicine, thereby ruining the reputation of Sanqing.
How did that happen? Sanqing did not commit fraud, and the efficacy of this medicine was actually real?
Blanche pulled her hair, trying to figure it out.
Suddenly, the phone rang, and it turned out to be Boss Mo from Fox News.
He quickly picked up the phone, preparing to face Boss Mo's anger.
Who knew that the voice on the other end of the phone was very satisfied with him.
"Blanche, you did a great job. You did a great job with this news feature. We received countless traffic, and now we are the most popular media on the entire Internet."
Blanche hesitated and said: "But, boss, when we said that Sanqing stole Pfizer's technology, we originally wanted to tarnish their reputation. Now it seems to have backfired."
"Haha, how could it be? Why do we want to ruin Sanqing? This is a pharmaceutical company, or a pharmaceutical company in the far east. Does his reputation have anything to do with us? No. Everything we do, no Is it all for traffic and attracting attention?”
Blanche suddenly realized: "So the process is not important, the result is important. As long as there is popularity and traffic, it doesn't matter what we do."
"Yes, only when you learn this can you be a real journalist. The audience is not important, only their attention is important. Work hard and keep the topic hot. You will benefit a lot."
