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Oswaldo Cruz Foundation an institution in the service of life

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COVID-19: Fiocruz and MSD sign an agreement to produce the first oral antiviral drug in Brazil


09/05/2022

Agência Fiocruz de Notícias and MSD

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Through its Institute of Drug Technology (Farmanguinhos), Fiocruz signed last Tuesday (May 3) an agreement of technological cooperation with American pharmaceutical company MSD (Merck Sharp & Dohme). The goal is to manufacture in Brazil the first oral antiviral drug to treat COVID-19. Last Wednesday (May 4) afternoon, Brazil’s National Agency for Health Surveillance (Anvisa) released the authorization to use the drug in the country on an emergency basis.

MSD team visited Fiocruz, which will produce its antiviral drug to treat COVID-19 (Image: Rogerio Resende)

With this agreement, Ficoruz will be in charge of storing, managing, labeling, packaging, testing, releasing, importing, and supplying molnupiravir to the Unified Health System (SUS, acronym in Portuguese for the Brazilian public health system). The agreement also includes the execution of clinical trials in partnership with the pharmaceutical company, for possible use as COVID-19 prophylaxis, and the beginning of experimental studies to analyze the activity of the drug against other viruses that are also endemic in Brazil, such as dengue and chikungunya.

“Fiocruz has always been in the front line when it comes to treatments against different diseases. In addition to the progress of COVID-19 vaccination in the country, we can now rely on a drug that helps reduce the number of patients with mild to moderate COVID-19 that progress into severe disease. This will certainly have a strong positive impact for the SUS and for the battle against the pandemic”, commented Fiocruz president, Nísia Trindade Lima.

The request for emergency use of the drug, presented by MSD last November, was approved by Anvisa last Wednesday (May 4). In addition to Brazil, the drug has been approved, under conditions, by the MHRA (Medicines and Healthcare Regulatory Agency), in the United Kingdom, and by the EMA (European Medicines Agency). It has also been approved for emergency use by the FDA, in the USA, and is currently in use in 17 countries.

“We are glad to be taking this initial step to make sure Brazilians have access to an effective drug that significantly reduces hospitalizations and cuts mortality by 89%”, commented Hugo Nisenbo, president of MSD in Brazil. He added: We have been discussing this partnership with Fiocruz since early 2021. We will now move on so the Foundation can meet the demands of the Brazilian Ministry of Health as quickly as possible”.

The signing of the technology transfer agreement at Fiocruz (Image: Peter Ilicciev)

As for the transfer of technology for the full Brazilian production of the drug, both institutions have already defined the premises to make this process feasible. The dialogue will continue throughout the next two years of partnership, to evaluate the technical and demand conditions of the SUS itself, considering the results of experimental and clinical trials that will be carried out. Farmanguinhos director, Jorge Mendonça, celebrated the result of the long process necessary to elaborate the agreement. He highlighted that negotiation resulted in a project with great potential to treat other diseases as well. “For more than a year we have been talking to MSD and following the evolution of tests and results, rooting for positive outcomes because we had a pandemic and an entire population to treat. I think we drew up a very robust document that not only provides us with another tool to combat COVID-19, but also with the chance to internalize the product and to use it for other diseases that are important for the SUS”, he said.

MSD will be in charge of monitoring and following, together with Farmanguinhos, the development of activities for the partial transfer of technology, providing assistance throughout the process. The agreement will be ruled by the Brazilian Innovation Law (10.973/2004), which incentivizes collaboration between government and private agencies for collaborative projects to promote national scientific and technological development, as well as the qualification, research, and innovation.

Indications of the drug

According to the emergency use authorization issued by Anvisa, monulpiravir will be indicated to treat Covid-19 patients above 18 years of age who do not require additional oxygen and who are at risk of evolving into the severe form of the disease. The drug will be available upon prescription only and must not be used by pregnant women.

At a meeting with the Collegiate Directory of Anvisa, held last Wednesday (May 4), director Meiruze Freitas highlighted that vaccination is still the best prevention against Covid-19, and emphasized that monulpiravir must not be considered a substitute for vaccines.

In a note released by Anvisa, the agency’s director-president, Antonio Barra Torres, stated that at this moment monulpiravir should be seen as another alternative treatment in order to reduce the number of deaths. “This is a drug designed for a very specific use and will demand constant monitoring. This is not a wide-spectrum drug to be employed freely in the COVID-19 pandemic. In this case, the vaccine is still our main weapon”, said the director in the note.

Understand the phase 3 results of molnupiravir

The results of phase 3 global clinical trial (multicentric, randomized, double-blind, and placebo-controlled) showed that the drug was capable of reducing by 89% the risk of death by COVID-19 when compared with placebo, with consistent efficacy against different variants of the virus. The tests included patients that did not require hospitalization, who had not received any dose of the vaccine, and who had at least one co-morbidity that increased the risk of evolution of the clinical condition. A higher percentage of participants in the Molnupiravir group reported sustained improvement and/or resolution of most signs and symptoms of the disease, while a higher percentage of participants of the placebo group reported progression of most signs and symptoms. The trial had seven centers in Brazil: three in São Paulo (two in the capital and one in São José do Rio Preto), Brasilia, Belo Horizonte, Curitiba, and Bento Gonçalves.

Phase 3 of the MOVe-OUT trial (MK-4482-002) began in April 2021 and evaluated molnupiravir as a treatment for outpatient use with confirmed COVID-19, with up to 5 days of symptoms (4 tablets, twice a day, for 5 days). Another phase 3 trial, MOVeAHEAD, is still ongoing and evaluates the efficacy and safety of the drug in the prevention of COVID-19 dissemination.

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