Mylan announced a global collaboration with Gilead Sciences to expand access to the investigational antiviral remdesivir for the potential treatment of COVID-19.
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 and Gilead have partnered for 15 years to fight infectious diseases like HIV and hepatitis C, reaching nearly 10 million patients in more than 100 countries with affordable medicine. We applaud Gilead's progress on remdesivir and are committed to continue deploying our resources and expertise in the fight against COVID-19 by applying our R&D and manufacturing capabilities to help expand access to this potential treatment option as it is further evaluated by regulatory authorities," Mylan CEO Heather Bresch said.
To ensure preparedness in this critical time of need, Mylan is confident it will be able to develop 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. We will be in a position to provide product in the coming months, subject to reviews by national regulatory bodies and the Prequalification Program of the World Health Organization (WHO).
"The unprecedented development timeline at Mylan is a direct reflection of the investments we've made to build a first-class, global research and manufacturing platform, including strong technical expertise in injectable dosage forms,” Mylan President Rajiv Malik said. “As a world leader in the supply of antiretroviral drugs upon which approximately 40% of those being treated for HIV/AIDs depend, we also understand supply chain complexities that must be overcome in order to ensure that the products we manufacture are able to reach the patients who need them. Today's announcement is another example of how Mylan's unique global infrastructure and expertise empower other companies to expand their own reach by providing more patients with access to critical medicines worldwide."
Remdesivir is an investigational new drug developed by Gilead Sciences. The treatment was recently granted emergency use authorization (EUA) to treat hospitalized COVID-19 patients in the U.S. In addition, it is recommended for compassionate use in Europe and recently received regulatory approval in Japan. Two global clinical trials conducted to date 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.