MORGANTOWN –Mylan announced on Tuesday that it is partnering with Gilead Sciences to expand access to the investigational antiviral drug remdesivir for the potential treatment of COVID-19.
Remdesivir, Mylan said, is an investigational new drug developed by Gilead. The treatment was recently granted emergency use authorization to treat hospitalized COVID-19 patients in the U.S.
It is also recommended for compassionate use in Europe and recently received regulatory approval in Japan, Mylan said. Two global clinical trials have demonstrated positive results, reducing the recovery time for patients with COVID-19, although the full efficacy and safety of the treatment are still under investigation.
Under the terms of the license agreement signed with Gilead, Mylan has rights to manufacture and distribute remdesivir in 127 low- and middle-income countries, including India. The agreement is non-exclusive, allowing for multiple licensees to ensure extensive access to this treatment, once approved as safe and effective for COVID-19 patients.
Mylan CEO Heather Bresch said Mylan and Gilead have partnered for 15 years on infectious disease drugs and Mylan is committed to deploying its resources to expand access to remdesivir as it’s being evaluated.
Mylan said it is confident it will be able to develop a bioequivalent version of remdesivir, including production of its own active pharmaceutical ingredient and the finished dosage form in sterile powder freeze-dried vials for administration of the medicine by intravenous infusion. It will be in a position to provide product in the coming months, subject to reviews by national regulatory bodies and the Prequalification Program of theWorld Health Organization.
Remdesivir is the tenth medicine licensed to Mylan by Gilead, who signed their first agreement in 2006 for an HIV medicine.
In a separate release, Gilead said that is has signed similar licensing agreements with four other generic pharmaceutical manufacturers based in India and Pakistan: Cipla Ltd., Ferozsons Laboratories, Hetero Labs Ltd. And Jubilant Lifesciences.
Under the licensing agreements, Gilead said, the companies have a right to receive a technology transfer of the Gilead manufacturing process for remdesivir to enable them to scale up production more quickly. The licensees also set their own prices for the generic product they produce.
The licenses are royalty-free until the World Health Organization declares the end of the Public Health Emergency of International Concern regarding COVID-19, Gilead said, or until a pharmaceutical product other than remdesivir or a vaccine is approved to treat or prevent COVID-19, whichever is earlier.
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