Pharmaceutical company Mylan NV (NASDAQ:MYL) said on Tuesday that it has entered into a global license agreement with Gilead Sciences to expand access to the investigational antiviral remdesivir for the potential treatment of COVID-19 in 127 countries.
Through this non-exclusive agreement, Mylan has rights to manufacture and distribute Gilead's remdesivir in 127 low- and middle-income countries, including India.
Mylan saidit has developed a bioequivalent version of remdesivir, including production of its own active pharmaceutical ingredient (API) and the finished dosage form (FDF) in sterile powder lyophilized vials for administration of the medicine by intravenous (IV) infusion, subject to reviews by national regulatory bodies and the Prequalification Programme of the World Health Organisation (WHO).
Remdesivir is an investigational new drug developed by Gilead Sciences and licensed to Mylan. The treatment was granted emergency use authorization (EUA) to treat hospitalized COVID-19 patients in the US, uses in Europe as well as received regulatory approval in Japan.
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