From "Global Hope" To "Falling Altar": Reed'S Way Of Commercialization Of West Wei

End the conjecture.

After two months of market discussion, analyst observation and speculation, gilde science finally announced the pricing of Reed levy.

In June 29th, an open letter released by Daniel O 'Day, chairman and chief executive of gilid said: "the price of developed countries is set at $390 per bottle by gilid." According to the current treatment mode, the vast majority of patients will receive 5 days of treatment, using 6 bottles, equivalent to 2340 dollars per patient. In the United States, Reed's price for the government is also 390 dollars per bottle. The price for private insurance companies will be $520 per bottle, and 5 days for each patient. It will cost 3120 dollars per patient.

Thanks to the global epidemic of new crown pneumonia and the lack of specific drugs, Reed's West Wei has been brought to the attention of the world, and became the world's "most popular" drug at the moment. It was called "global hope" by netizens in the early days of the outbreak.

From January 31st, Reed went to the public view through the new England Journal of Medicine (NEJM). In April 29th, the lancet officially released the data of Reed's first clinical trial. In June 29th, gilid released the commercial pricing of Reed West.

In less than half a year, Reed Wei went through various clinical trials all over the world, and finally got approval in many countries and quickly opened the way of commercialization.

Under the scientific verification, the Reed West Wei myth, which has been in the global public opinion, has been broken. Reed Wei Wei is an effective medicine for the treatment of new crown pneumonia, but it is not a specific drug.

"Born out of the world"

In January 31st, the new England Journal of Medicine published online a paper on the first confirmed case of a new coronavirus in the United States. The medical treatment, treatment and clinical manifestations of the patient were described in detail.

Most notable of all, in January 19, 2020, a 35 year old man from Wuhan returned to the United States to be diagnosed with new crown pneumonia in Washington state. The patient underwent a substantial improvement after receiving an antiviral treatment called Reed West Wei. "As of January 30th, the patient was still hospitalized, but all the symptoms were good except cough, and the severity of the cough was relieved." 。

Reed Xi Wei became famous in World War I.

This is the first time that Reed West has appeared in the global public view after the outbreak. After a round of popular science, we all know that Reed Wei Wei is a nucleotides analogue, and its principle is to inhibit RNA dependent RNA synthetase (RdRp). At first, it was developed by Ebora, the antiviral pharmaceutical company. However, the Ebola effect is not good enough. Because the new coronavirus also has RdRp, and in vitro and in vivo animal models have proved that SARS and MERS virus pathogens are all active, the researchers speculate that it is also effective for the new crown pneumonia virus.

At that time, Reed Siwei was not licensed or approved for use in any country or region in the world, "Merdad Parsey, chief medical officer of gilde, said at the time." there is limited clinical data available for the emergency use of Reed's treatment of Ebola virus infection. Although there is no antiviral data for Reed's disease, the other available data of coronavirus give us hope.

But this does not prevent Reed from being a potentially effective drug. For a time, clinical trials, patent disputes, and "heat up" stock raising related businesses were bustling, becoming a major "wonder" during the epidemic.

"We think Reed Xi Wei may have expected effect." In the evening of February 24th, WHO China coronavirus joint expert inspection group held a news conference in Beijing, the joint inspection team leader Dr. Bruce Aylward said.

During the special period, the regulators of various countries also gave the green light to Reed West. At that time, it was the burning period of the epidemic in China. Two Reed Xiewei clinical trials conducted by China-Japan Friendship Hospital were rushed through and carried out in Hubei province. The FDA also approved a clinical trial led by the National Institute of allergy and infectious diseases (NIAID) after a quick review. Since then, Reed has carried out clinical trials in other countries with severe epidemics in the world.

Reed's clinical trial may be the most watched test in the history of pharmaceuticals. During the months of waiting for blindness, people everywhere can see the anxiety of the whole world.

In April 10th, in response to the global progress of Reed West, Daniel O Day released an open letter saying that currently, seven clinical trials of Reed's West Wei have been launched. It is expected that at the end of April, Reed's preliminary data for severe patients will be obtained, but in China, the study of severe patients has stopped because of the stagnation of entry. Become a major turning point for Reed West.

In April 29th, the boots landed, and there was a "big match on the same stage". The lancet officially released the results of the first clinical trial of Reed Sewell, a randomized, double-blind, placebo controlled multicenter trial conducted in ten hospitals in Hubei, China. The results showed that compared with placebo, the treatment of Reed's administration did not significantly improve the clinical improvement time, mortality or virus clearance time in patients with new crown pneumonia.

In other words, the efficacy of Reed's Wei is not obvious.

On the same day, gilid and the National Institutes of Health (NIH) announced that their clinical trials showed that Reed and Wei showed positive effects and reached their main endpoints. Patients with advanced Reed's disease recovered faster than those who received placebo.

In spite of this, it also experienced dazzling events such as FDA's awarding of Reed's "orphan drug identification" and Gillie's request for withdrawal. In May 1st, Reed Sewell ushered in a regulatory breakthrough. FDA awarded the emergency use permit (EUA) of Reed Wei Wei to treat severe new crown pneumonia (EUA). "Although little is known about the safety and efficacy of the use of the new crown pneumonia in the treatment of Reed's new crown pneumonia, the test drug has been shown in a clinical trial to shorten the recovery time of some patients."

According to the results of NIAID and other clinical trials as well as the approval of FDA, Reed West Wei has obtained emergency application permission in Japan and the United Kingdom and other countries and regions.

Capacity for mass production and commercialization

The results of clinical trials are the "watershed" of Reed's "fate".

Different results have broken people's illusions about their "specific drugs", but Reed Wei Wei is still one of the clinically selected drugs.

For the industry, after proving its effectiveness, the focus of attention has been turned into capacity and subsequent commercialization. In May 5th, Reed issued a statement on the expansion of his supply after the FDA emergency use authorization was received by the company.

Earlier, Daniel O 'Day also said in an open letter, "our team has been accelerating production since January. Including the finished product and the final production stage, we have a total supply of 1 million 500 thousand agents. We estimate that these will be used for 140 thousand 10 days of treatment. "

In April 4th, Daniel O 'Day also said, "our goal is to strive to produce more than 500 thousand courses of drugs by October, and the supply will exceed 1 million courses by the end of this year. To help us achieve and exceed this goal, we are developing an alliance of pharmaceutical and chemical manufacturers, which are distributed all over the world to expand the global capabilities of raw material supply and production. "

In May 13th, gilid announced that it had signed a non exclusive voluntary licensing agreement with 5 generic drug manufacturers in India and Pakistan to further expand the supply of Reed Siwei and supply 127 countries and regions. This covers almost all low and middle and low income countries and regions, as well as some middle and high income and high-income countries with significant medical barriers.

Based on the authorization agreement, these companies will get Gillie's technology transfer on Reed's way of production, so as to speed up the scale of production. The authorization also sets the price of the generic drugs produced by them.

In contrast to donations and generic drug licensing, Wall Street and the pharmaceutical industry are more concerned about Gillie's return on Reed West. Evaluate Pharma, an analyst, said that the price of Jill Reed was 23% and its market value increased by 18 billion US dollars.

Evaluate Pharma believes that a number of Reed's clinical trials of III are probably the most expensive investments at present. Gilde can afford to do so. If Reed is effective, its business returns may be enormous.

In April 30th, gilid announced the 2020 quarter results, with revenue of $5 billion 500 million, an increase of 5% over the same period last year. The increase in R & D costs is mainly due to the cost of developing new crown pneumonia in Reed West, including the $50 million expansion of production scale and clinical trial costs.

According to Daniel O 'Day, "we expect to invest more than US $1 billion in the development and production of Reed West, and our commitment will continue until 2021 and beyond."

The market then aroused great curiosity. Analysts SVB Leerink predicted that Reed's sales could reach $7 billion 700 million in 2022, and the drug's operating margin will peak in 2021.

In May 1st, the Institute for clinical and economic review of the non profit Research Institute (ICER) released the analysis of the different pricing models of Reed's treatment of new crown pneumonia, giving two huge differences: $10 and a maximum ceiling of $4500. In June 24th, ICER updated the pricing model of Reed levy, which costs about 4580 to 5080 dollars per patient because of its high cost effectiveness. But if the low cost steroid dexamethasone is effective, Reed's price should be reduced to between $2520 and $2800.

Judging by the price announced by Reed West, it is in line with the above model, but lower than that expected by Wall Street analysts.

Daniel O 'Day also explained its pricing, the price of 390 US dollars per bottle, "part of the consideration is to eliminate the necessity of negotiations on prices. We have reduced the price to the level that the developed countries with the lowest purchasing power can afford. This price will apply to all developed countries in the world that approve or authorize the use of Reed West. "

In addition to its formal entry into commercial operation, gillit's exploration of Reed West has not stopped: experiments will be conducted in inhaled preparations and paediatric inpatients; the next stage of clinical development will be explored in the early stages of disease treatment, in combination with other therapies, and in more patient groups such as outpatient applications.