The medication, which uses Primaquine as its active ingredient, is already manufactured and marketed in Brazil and has now been submitted to Infarmed for authorization to be marketed in Portugal, in accordance with European regulations.
Its introduction in Portugal will be handled by ICNAS Pharma, a company fully owned by the University of Coimbra (UC), based at the Institute of Nuclear Sciences Applied to Health (ICNAS), which markets radiopharmaceuticals to Portuguese hospitals and holds all necessary authorizations from Infarmed, the national medicine authority, for the commercialization of pharmaceuticals.
“An opportunity has arisen through this partnership with the Fiocruz Foundation, linked to the Brazilian Ministry of Health, which also includes the pharmaceutical company Framanguinhos, responsible for producing various medicines, leading to a very close framework and convergence of interests,” stated Antero Abrunhosa, director of ICNAS Pharma.
Once it receives approval, anticipated to occur within a few months, the medication will be produced in Brazil. However, batches for the Portuguese market will have a distinct brand, which will be disclosed upon authorization by Infarmed.
“ICNAS Pharma, having European marketing authorizations for medications, will be the entity responsible for introducing the drug to the Portuguese market,” clarified Antero Abrunhosa.
Though the medicine will be produced in Brazil, it will undergo testing in Coimbra and subsequently be accredited according to European standards before being commercialized in Portugal. This involved harmonizing Brazilian and European standards at ICNAS Pharma over the past months, prior to submission to Infarmed.
Antero Abrunhosa indicated that the sole interest is in commercializing the anti-malaria medication in Portugal, “even though it is not an urgent public health situation in Portugal, it exists and is a growing problem.”
“There are instances of malaria due to immigration, Portuguese tourists, and climate change, which may introduce the disease to Europe, making it crucial to be prepared with treatment options,” he emphasized.
In the partnership’s second phase, ICNAS Pharma aims to introduce its products to the Brazilian market, a process currently under evaluation, with developments expected in the coming months, as projected by Antero Abrunhosa.
This partnership between the University of Coimbra and the Fiocruz Foundation also involves the Institute of Hygiene and Tropical Medicine, which researches diseases like malaria, demonstrating a “coordination of interests between research entities and pharmaceutical production that may serve the National Health Service.”
The partnership agreement was signed this afternoon at the University of Coimbra, featuring remarks from various participants, including the rector, Amílcar Falcão, and the president of the Fiocruz Foundation, Mário Moreira.
