Fragments of a press conference on the results of clinical trials of Areplivir

Medicines

09.10.2020

On 23.09. 2020, MIA Rossiya Segodnya held a press conference, during which the PROMOMED Group of Companies, which developed the COVID-19 drug Areplivir, held an open discussion of the results of clinical trials of this drug for the FIRST time in Russia. We are introducing you to the most important issues raised at the press conference.

Why is the development and production of Areplivir a historic event?

Dmitry PUSHKAR, Chief Researcher, Academician of the Russian Academy of Sciences: "In a short time and in a pandemic, it was necessary to find a molecule with a dual mechanism of action. For the first few months, we treated COVID-19 with whatever was falling nearby. A safe drug had to be found that eliminates the virus and prevents it from developing. And we succeeded."

How did this become possible?

Peter BELY, Chairman of the Board of Directors of PROMOMED Group of Companies: Areplivir is the first drug with direct antiviral, etiotropic action, it eliminates the cause of the disease with 98% effectiveness. At the same time, it is incredibly safe. This is a revolutionary story. How did this become possible? First of all, we are indebted to the tremendous work of the Government and the Russian Ministry of Health, which issued a special decree in the early days of the pandemic in the world aimed at facilitating the release of a drug for the treatment of coronavirus.

In a typical situation, it takes weeks or months for a clinical trial protocol to be reviewed and approved. It took a few days here. The Russian government allowed partial data to be used to bring the drug to hospitals under medical supervision, which saved thousands and tens of thousands of lives. This is a stunningly effective government tool that has brought tremendous results.

I would like to express my special gratitude to the brilliant team of researchers, led by two full members of the Academy of Sciences and internationally recognized doctors Dmitry Pushkar and Larisa Balykova. Separately, I would like to mention the amazingly well–coordinated work of scientists, technologists, developers, doctors, clinicians, and apparatchiks - hundreds of people who worked without holidays and weekends. If we switch the clock to the normal course of events, it turns out that it would have taken 2 years to achieve such a result. The combination of all these factors together has made it possible to create such an effective, vital and safe drug in record time."

What is the proven effectiveness of Areplivir?Larisa BALYKOVA, Director of the Medical Institute of the National Research Mordovian State University named after N.P. Ogarev, Corresponding Member of the Russian Academy of Sciences, Professor: "The research results showed that patients treated with Areplivir improved faster than in the group of patients receiving standard therapy for an average of 4 days. Patients from the moderate category were twice as likely to be treated as outpatients. About 90% of patients were discharged from the hospital by the 10th day of treatment with Areplivir and did not experience any major changes in their daily work. It has also been proven that Areplivir therapy improves the condition of the lungs according to CT data."

Does Areplivir have side effects? Professor Larisa BALYKOVA: "The risk of adverse reactions is not higher than when taking standard therapy drugs. The only thing worth talking about is that the drug is contraindicated during pregnancy."

Dmitry PUSHKAR, Chief Researcher, Academician of the Russian Academy of Sciences: "Areplivir belongs to the classes of drugs with the lowest profile of side effects."

Why is it wrong to call Areplivir a generic drug? National Medical Manager of PROMOMED Group Kira ZASLAVSKAYA: "We only knew the chemical formula, everything else is a patented secret of the manufacturer of the Japanese remedy. Accordingly, we needed to develop our own synthesis method and, most importantly, develop an original production technology for the tablet itself."
Does PROMOMED cooperate with WHO? Kira ZASLAVSKAYA, National Medical Manager of PROMOMED Group, said: "We are actively cooperating with WHO so that the research we conducted can be continued in various countries as part of the Solidarity study.
Are there any requests from other countries for Areplivir? Chairman of the Board of Directors of PROMOMED Group Peter BELY: "A huge number of requests are received from foreign countries. Geography is the whole world. It is worth noting that the supply of each drug for export is related to the fact that the state purchasing any drug has a registration procedure (just like in our country). And as these issues are resolved in the recipient countries, we are starting to supply the drug. The interest is huge, our export department is working with dozens of requests and their number is constantly increasing. Deliveries to a number of countries have already begun."
Why is the price of Areplivir so high? Andrey MLADENTSEV, Chief Executive Officer of PROMOMED Group: "A large team worked to ensure that the drug was created, registered and put into circulation as soon as possible. Enormous financial and human resources were expended. The total investment from development to creation amounted to 692 million rubles, and we did not receive any government funding. And, of course, all this affects the price."
Chairman of the Board of Directors of PROMOMED Group Peter BELY: "The entire team of the company is working to improve the technology and to reduce the cost of this product. We had to build a separate workshop for the production of substances. This is a huge investment. But the technology created will allow us to scale production, which in turn will reduce the cost of the drug."