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On Wednesday (11), the Butantan Institute and MSD Pharmaceutical Company (Merck, USA) announced the signing of a collaborative agreement for the development of the dengue vaccine, which could yield more than $ 100 million. US dollars (about 390 million rand). ) to the Brazilian institution, in addition to royalties.
The plan provides for an exchange of information on vaccines based on the attenuated dengue virus TV003 obtained from the NIH (National Institutes of Health of the United States). The butantan vaccine is in phase 3, the last before the launch of the product, while the US company's version is still in the first stage of testing on humans.
For MSD, the information can ensure an easier launch of the vaccination. Under this agreement, the company will market the product, if it is launched, to markets in North America and Europe, among others. In Brazil, the distribution will remain with Butantan.
Butantan would receive royalties on these sales and could benefit from certain tests to be developed in places where viruses other than those in Brazil (where the institute vaccine has been tested) circulate. (19659002) By knowledge transfer, MSD would pay $ 26 million (R $ 100 million) for butantan and, depending on (reaching phases 2 and 3 of clinical trials, for example) more than $ 75 million.
"This is a great day for us, the work that Butantan has done so far has been excellent, of scientific excellence, we are proud to open this collaboration and learn from it." said Mike Nally, global president of vaccines at MSD, who is also developing partnerships with the institute for the development of HPV and hepatitis A vaccines. "
Dimas Tadeu Covas, Butantan CEO said that vaccine production in the country is expected to start next year, but that Anvisa (National Health Surveillance Agency) will still be needed.
The former director of Butantan and l 39; Immunologist Jorge Kalil, currently a professor at Harvard, although he did not participate in the final phase of the collaboration design with the MSD, is very enthusiastic about the initiative and the transfer of technology in the sense south-north, initiated in its management.
A year and a half ago, as stated in Folha waiting An agreement that would represent a gain of $ 1.5 billion on ten years for Butantan (including royalties). In this regard, Covas estimates that there could be a gain of more than $ 101 million, depending on the sales of the TMS vaccine in other parts of the world.
The Phase 3 study in Brazil has nearly $ 17 million. thousand participants among those who have had dengue fever or who have never had contact with the virus. From the attenuated viruses, Butantan produced a freeze-dried vaccine (powder) that is tested in 16 centers in all regions of the country.
The initiative was supported by the BNDES, Fapesp (Amparo Foundation) State Research of São Paulo), the Butantan Foundation (related to the institute) and the Ministry of Health In total, 224 million R $ has been invested to date, the total invested in development can reach R $ 300 million.
At present, the only available vaccine against dengue fever is Dengvaxia, from the French multinational Sanofi. However, experts say its use should be cautious. Recently, the company itself has updated information about vaccines, which are no longer recommended for people who have never had dengue fever. In a global badysis, the doses generate a protection of 66%.
This vaccine is also criticized for the low protection against virus subtype 2 and the need for three doses for complete protection. The reduction of more than 90% of severe cases of dengue (dengue haemorrhagic fever) is an advantage.
STEP BY STEP FOR CLINICAL RESEARCH
Preclinical
Prior to human testing, vaccines are tested on animals. If it is toxic or it does not work, it will not go further
Phase 1
The idea is to see if the vaccine is without danger; its effectiveness has not yet been evaluated. The test is performed on healthy humans
Phase 2
Phase 3
With some volunteers, about a hundred people, we check if he is vaccinated. 19659017] Organized with thousands of individuals, it examines whether the vaccine is capable of preventing new infections. Approval
Proven efficacy sufficient, variable depending on disease and target audience, It is at this stage that research on the vaccine Butantan
the vaccine may be authorized for production and distributed
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