AMIVAS Launches Europe’s First and Only Licensed Severe Malaria Treatment

• Artesunate AMIVAS is now available for purchase across Europe and U.K. through Nordic Prime of Denmark.
• Artesunate AMIVAS, approved by EU Commission and U.K.’s Medicine and Healthcare Product Regulatory Agency to treat severe malaria both in children and adults in Europe, is the only fully licensed such product.
• Annually, about 1,250 individuals in Europe are diagnosed with severe malaria; most cases are military personnel deployed to malaria-endemic regions or civilian travellers returning from a visit to those regions.
• Severe malaria has a mortality rate approaching 100 per cent when left untreated; infant, children, pregnant women are among those at highest risk

WATERFORD, Ireland–(BUSINESS WIRE)– AMIVAS Ireland Ltd (AMIVAS), a biopharmaceutical company focused on developing, commercialising, manufacturing and distributing artesunate for the treatment of severe malaria, today announced the launch of Artesunate AMIVAS in Europe and the U.K.

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Artesunate AMIVAS is the first and only product licensed, manufactured in a regulated setting, and approved to treat severe malaria in the EU, European Area (EEA), and the U.K. Severe malaria is a disease that impacts an estimated 1,250 European travelers each year. Artesunate AMIVAS is sold as a 110-milligram powder and solvent combined to create an injectable solution.

Artesunate AMIVAS is now available from the Scandinavian distributor, Nordic Prime in Denmark, Finland, Sweden and Norway. To order, see https://www.nordicprime.dk/h

“The launch of Artesunate AMIVAS across Europe means that, for the first time, travelers to and from malaria-endemic regions of the world, and military personnel deployed there, now have access to a licensed, approved severe malaria treatment that could save their lives if needed, said Laura Walsh, AMIVAS Operations Director. “Because of the well-established safety and efficacy profile of Artesunate AMIVAS, healthcare practitioners can now be confident when treating an adult or child diagnosed with severe malaria.”

“It is gratifying to be launching Artesunate AMIVAS in Europe after its successful launch in the United States,” said Sean Power, AMIVAS Director, Ireland. “The AMIVAS mission is focused on bringing safe, effective, fully licensed and approved treatments to patients in need in order to extend and improve their lives. This launch milestone is clear proof of our commitment to that pledge.”

The U.S. Food and Drug Administration approved Artesunate for Injection™ in May, 2020 to treat severe malaria in adults and in children. AMIVAS (US) holds the license.

The European Union Commission awarded approval to AMIVAS Ireland to commercialise Artesunate Amivas in the EU and EEA in late 2021. Approval was granted by the U.K. MHRA in April, 2022.

About Severe Malaria

Malaria is a febrile disease caused by Plasmodium parasites and is usually transmitted by mosquitos. In 2020, almost half of the global population was at risk of contracting it. Over 400,000 deaths are recorded each year from the disease, with sub-Saharan Africa’s population being most at risk. In Europe, 50 years after eradication, malaria is still a major health concern. While most infections in Europe are related to international travel, climatic changes are foreseen to enhance the risk for locally transmitted malaria infections in Europe. In Europe, peaks in the number of malaria cases occur July to September. Since the vast majority of malaria cases are imported, this could partly be linked to travellers returning from summer holidays. Malaria can progress to severe malaria, at which point the mortality rate approaches 100 percent if left untreated. Infants and children under five, pregnant women, and people with low immunity are at highest risk of developing severe malaria. Artesunate has been shown to improve survival rates, with particular benefit for patients with high parasitaemia. Complications of severe malaria include severe anaemia and signs of end-organ damage, such as coma (cerebral malaria), lung complications, hypoglycaemia (low glucose blood levels), or acute kidney injury.

Travelers can protect themselves before, during and after travel (https://www.ecdc.europa.eu/en/malaria).

About Artesunate AMIVAS

Intravenous artesunate has been the global standard of care for severe malaria for more than 20 years. Artesunate AMIVAS is approved for the initial treatment of severe malaria in adults and children by the U.S. Food and Drug Administration, the European Medicines Association, and the Medicine and Healthcare Product Regulatory Agency.

Artesunate is associated with up to a 34.7 percent reduction in risk of mortality compared with quinine. Supplied as a sterile powder, Artesunate can be safely stored at room temperature. Artesunate is easily prepared for use in one step.

Artesunate AMIVAS is superior to standard intravenous quinine in the most important clinical parameter, mortality. Artemisinins, the active ingredient in Artesunate AMIVAS, are the fastest-acting clinical anti-malarial compounds. They can be administered intravenously only when formulated to do so.

About AMIVAS

AMIVAS, based in Nassau, Delaware, in the United States, is a post-approval biopharmaceutical company, founded with a mission to improve and extend human lives by discovering, developing, and distributing new best-in-class medicines. AMIVAS responded to the urgent need for a United States- and European-based firm to assume responsibility for regulated manufacture and distribution of Artesunate after quinidine gluconate was discontinued in the U.S. in 2019. The Company achieved U.S. Food and Drug Administration approval for Artesunate for Injection – its first commercial product – in May, 2020. Artesunate for Injection is indicated for the treatment of severe malaria in adults and children. AMIVAS is committed to being the global leader in the battle against infectious diseases, driving scientific discovery and breakthroughs that will redefine the possibilities of critical medicines.

For more information, visit AMIVAS.com and follow AMIVAS on LinkedIn.

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