The death rate is reduced by 55%!

In the post-epidemic era, perhaps people have become accustomed to living with masks, but the virus variants that make a comeback from time to time have repeatedly reminded that in the war against the new crown virus, we must not slack off

On Monday, a public company called Veru announced that its new crown drug candidate, Sabizabulin, performed well in a phase III study.

A Veru spokesperson said that sabizabulin is the first drug to significantly reduce mortality in hospitalized patients with moderate to severe Covid-19, a fact supported by solid clinical evidence and statistical data

Considering the drug's excellent efficacy in an interim analysis, the Independent Data Safety Monitoring Committee (IDMC) recently recommended that Veru stop the Phase III trial early

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Remdesivir is a broad-spectrum antiviral drug that targets RdRp and is the first FDA-approved treatment for COVID-19

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Recent trends in the new crown epidemic

In 2021, there will be about 180 million new coronavirus patients worldwide

In a recent conference call, Veru said that the government may increase spending to stimulate economic recovery, and is expected to spend more than $2.

The revenue generated by Sabizabulin comes directly from the hospital

Veru revealed that the company is currently planning to meet with the FDA and is expected to discuss the next steps this month, including submitting an emergency use authorization (EUA) application

After obtaining EUA authorization, Sabizabulin will be used in combination with other antiviral drugs, such as remdesivir

There is no way to know the pricing of Sabizabulin, but Veru warned in its financial report at the end of 2021 that the Sabizabulin treatment may be controlled by government pricing or affect the profitability of the drug

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In order to fight the epidemic, many government agencies are taking corresponding incentive measures, authorizing or signing contracts to encourage enterprises and institutions to invest in new crown prevention and treatment drugs
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Capacity factors at one point limited revenue for Pfizer's Paxlovid
.
Based on its estimate of 120 million courses of treatment, Pfizer will produce 3.
6 billion pills in 2022
.
In order to digest this goal, Pfizer not only incorporated Italian and Irish production sites into Paxlovid's supply chain, but also actively sought new production capacity bases
.
Local CDMOs Asymchem and Porton have also received orders of over 10 billion yuan
.
And what about Veru's production capacity? Is there any possibility of cooperation with domestic CDMOs? Veru gave the answers one by one in the investor meeting
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First of all, Veru believes that production capacity will not limit its supply, mainly for two reasons: First, Sabizabulin is a small molecule drug with a straightforward production process, and its recommended dose is 9 mg a day, one tablet per day, with little production pressure; Second, the dosage form of Sabizabulin is a tablet, which means that no cold chain storage and transportation is required, and manufacturing and distribution costs are low
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Veru revealed that in order to better cope with the increased demand for drugs after approval, it is currently cooperating with a number of companies to jointly promote the expansion of production capacity to increase the supply of drugs
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The entire production process and process are carried out in the United States.
In order to stabilize the supply chain, Veru will not use APIs from China or India
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In the public information, there is no disclosure of cooperation with local CDMOs
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Distribution is an important part
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Veru said the company has been in discussions with BARDA and other U.
S.
government agencies to secure an advance purchase agreement
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However, the distribution of Sabbizabulin is mainly based on the hospital route, because it is aimed at the inpatient population
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Here we mention the concept of a GPOs
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GPOs are centralized drug procurement organizations, which integrate hospital orders and negotiate with suppliers in large-scale orders
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It is an important part of the US pharmaceutical supply chain
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There is a standard process for hospital distribution
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Once a drug is on the GPOs list, the distribution process happens naturally
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This also makes the production demand of Sabizabulin manageable without causing a lot of production pressure
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When the epidemic breaks out on a large scale, how to distribute quickly is a test of the operation mechanism of pharmaceutical companies
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Especially in the competition of similar drugs, the speed of distribution has also become an important part of grabbing the market
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In January, Pfizer's Paxlovid distribution speed surpassed Merck's Molnupiravir for the first time
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Distribution of neutralizing antibodies and new crown oral drugs (source: medical notes)

Veru's distribution preparations have not yet been known.
In the conference call, Veru declared: "Hopefully, we can smoothly pass the regulatory process of the US and foreign governments to distribute Sabizabulin as quickly and efficiently as possible to all parts of the world
.
"

References

1.
Veru's Novel COVID-19 Drug Candidate Reduces Deaths by 55% in Hospitalized Patients in Interim Analysis of Phase 3 Study; Independent Data Monitoring Committee Halts Study Early for Overwhelming Efficacy

2.
Early wrap up for Veru's COVID trial spurs doubling of share price, race to regulators

3.
Veru Soars as Oral COVID-19 Antiviral Reduces Deaths by 55%

4.
Veru: Investor call on April 11