Analysis of Global Clinical Trial 3 of Remdesivir

Period : Feb 21 2020 ~ Apr 19 2020

Countries : Around 10 countries / 60 Trial Sites

45 sites in the United States, 8 sites in Denmark, 5 sites in the United Kingdom, 4 sites in Greece, 3 sites in Germany, 2 sites in South Korea, 2 Sites in Mexico, 2 Sites in Spain, 1 site in Japan and Singapore.

Patients Attending to Clinical Trial 3 : 1063 patients

Test Method : Double-Blind - Giving placebo(a fake drug) and Remdesivir to both patients and doctors without being informed. In other words, the patient who was prescribed the drug doesn't know whether it is Remdesivir or a fake drug and only knows that it is a drug. Even Doctors don't know whether the drug given to the patient is Remdesivir or a fake drug. 

In the Phase 3 Clinical trials, the total patients were 1063. And 541 were prescribed Remdesivir (Real) and 522 were prescribed placebo(Control). Remdesivir and Fake drugs were prescribed at almost 1:1 ratio. The dosage method was 200mg of remdesivir on the first day and 100mg daily for left 9 days from the second day.

According to the Clinical result "Patients in the remdesivir group had a shorter time to recovery than patients in the placebo group"

Median is 11days as compared with 15 days; rate ratio for recovery, 1.32; 95% Confidence interval [CI]

The picture above is the clinical test phase 3's report. The line marked in red is the baseline 1.0 The horizontal bar indicating the result should not violate the red line to the left. In other words, the horizontal bar should come out to the right with red as the baseline, and if it is violated to the left, it can be confirmed that statistically significant results were not obtained. 

However, if you look at the areas highlighted in red in the date of Phase 3 Clinical trial above, it can be seen that Remdesivir did not produce statistically meaningful results in European and Asian. Although it is deemed to be effective, this alone cannot statistically explain that the patient was cured because of Remdesivir.
The above data, it proved that there is a clinical effect in the white race, but failed to derive statistically significant results in the black and Asian race. The reason for this conclusion was that there were 563 white samples, which is more than half, 219 blacks and 134 Asians. So, it is tried to infer whether this result is due to insufficient samples.

As described above, although the results of phase 3 clinical trials of Remdesivir are only useful in some cases and the effect of shortening only 4 days out of a total of 15 days of treatment is unattractive, the demand for Remdesivir is increasing and the price is high because of whether it is fear of COVID-19 or there are no drugs approved by governments around the world excluding Remdesivir right now.

Recently, it is confirmed that Gilead Sciences is supplying 100mg/1vial for US$400, and a total of US$4,400 is required for 10 treatments (200mg for the first treatment). While Gilead has already begun consultations on License out of Remdesivir with pharmaceutical companies in other countries to supply Remdesivir as a treatment for COVID-19, several companies in developing countries have already succeeded in developing and launching generic drugs of Remdesivir and the supplying price of the Generics is remarkable.

Company

Country

Price / Vial

Eva Pharma

egypt

US$125

Beximco Pharmaceutical

Bangladesh

US$65

Eskayef Pharmaceutical

Bangladesh

US$160

Zydus Cadila

India

US$45

BEXIMCO pharmaceutical, Bangladesh's largest pharmaceutical company, now produces Remdesivir and has a price of US$65/Vial. In Bangladesh and Egypt where are the countries that the WTO's Compulsory license rules applied, so production and sales are possible regardless of patents. (Compulsory license : The right to forcibly use a patent without the permission of the intellectual property right holder in case of a national emergency or for public non-profit purposes when it is not possible to obtain permission with reasonable terms and conditions from the intellectual property right holder written on WTO TRIPs) However, in the case of India, even though it is a region where patents are registered and implemented, it is the norm that Remdesivir is already prevalent in illegal markets.

Would the Gilead's price of Remdesivir of US$ 4400 be reasonable?

The source is difficult to pinpoint, but the Remdesivir's API(Active Pharmaceutical Ingredient) price I've checked is currently around US$ 80 to US$ 90 in the world. 1G equals to 9 vials (in the condition of loss 100mg). If so, the manufacturing cost is calculated as $15/vial even if the vial price and subsidiary materials are included. Of course, the development cost that Gilead invested will be enormous, but it can be thought of as adding about 25 to 30 times the profit per vial.

There is a controversy over the cost of treatment effectiveness. However, in the market where there is only one treatment, Gilead, who is occupying the market's monopolistic position due to patents, should be necessary to think again between maximizing the company's profits and human health.