Amivas Receives FDA Approval for Its Life-saving Treatment of Severe Malaria

Over the past 12 months, I have had the pleasure of working with Amivas, LLC, an Orphan Drug development company that specializes in treatment for rare and neglected tropical diseases. I would like to provide my most sincere congratulations to Mark Reid, CEO and Bryan Smith, MD, Chief Medical Officer at Amivas on the FDA approval of injectable Artesunate for the treatment of severe malaria.



As Bryan Smith has stated, “When a patient with severe malaria arrives in the clinic, emergency room or elsewhere, immediate treatment with a safe, efficacious, fast-acting, injectable therapy is absolutely critical to saving that life.” Artesunate for Injection fills this critical need and has now been approved by the FDA for the initial treatment of severe malaria for both adult and pediatric patients.


In two studies that examined a total of 6,886 patients, including adults, children, and pregnant women, this lifesaving treatment for severe malaria reduced mortality by an incredible 34.7 percent and 22.5 percent.


Artesunate for Injection will be manufactured, distributed, and commercialized by Amivas, who is currently completing the set-up of a nationwide product distribution network.

The specific purpose of forming Amivas in 2016 was to make this life-saving drug readily available in the United States. Congratulations on achieving this excellent goal. Sometimes people do what they say they are going to do.



Seth Yakatan

Partner, Katan Associates, Inc


Seth Yakatan has more than 20 years of experience as a corporate finance professional, actively supporting small-cap and major companies in achieving corporate, financing, and asset monetization objectives through the successful structuring and management of strategic transactions and investments totaling more than several billion dollars in value.


www.katanassociates.com


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