Mylan Chairman Robert J. Coury and Chief Executive Officer Heather Bresch provided additional detail regarding the company's efforts to meet public health needs amid the evolving COVID-19 pandemic.
As the situation surrounding the COVID-19 pandemic continues to evolve, Mylan's priorities remain protecting employees, continuing to supply critical medicines to patients in more than 165 countries, utilizing the company's scientific and operational expertise to assist where possible in the needed potential prevention and treatment efforts, and extending support to communities where the company operates.
Mylan is continuing to collaborate with pharmacies, wholesalers, governments, public health officials and healthcare providers to help address patient needs. The company is working within existing supply chain channels and coordinating with healthcare stakeholders and governments around the world to actively analyze volume requests for critical products facing increasing demand and is adjusting supply capabilities, where possible, accordingly.
As previously announced on March 19, 2020, Mylan re-started production of generic hydroxychloroquine sulfate tablets, 200mg, at its Morgantown, WV, USA manufacturing site to meet increasing demand in the context of COVID-19. Mylan expedited its manufacturing of hydroxychloroquine tablets and product has been made available ahead of schedule. The company is donating 10 million tablets of hydroxychloroquine sulfate, 200mg, to the U.S. Department of Health and Human Services (HHS), through its Assistant Secretary for Preparedness and Response (ASPR), for possible use under an investigational new drug application authorized by the U.S. Food and Drug Administration (FDA) or an Emergency Use Authorization granted by FDA. FDA issued an Emergency Use Authorization to ASPR's Biomedical Advanced Research and Development Authority (BARDA) to permit the emergency use of hydroxychloroquine sulfate supplied from the Strategic National Stockpile to treat adults and adolescents who weigh 50 kg or more and are hospitalized with COVID-19 for whom a clinical trial is not available, or participation is not feasible.
The company has also begun shipping additional product to wholesalers within the U.S. to help support existing patient needs to address shortages for FDA-approved product use. Mylan's hydroxychloroquine sulfate tablets are currently approved by the FDA for the treatment of malaria, lupus erythematosus and rheumatoid arthritis.
Mylan is donating product to the World Health Organization (WHO) to support its investigation of the potential effectiveness of several medicines in treating COVID-19. Mylan is the only company providing hydroxychloroquine sulfate tablets, 200mg, and one of three companies supplying lopinavir/ritonavir tablets, 200/50mg, as part of the WHO's global SOLIDARITY trial.
The WHO SOLIDARITIY trial is a multi-arm, multi-country, adaptive, clinical trial investigating potential therapies to treat COVID-19. It is part of the WHO's accelerated effort to determine which, if any, of four therapies reduce mortality, hospital duration, and/or the need for ventilation or ICU for patients diagnosed as COVID-19 positive.
The therapies being investigated are the antiviral remdesivir; a combination of two HIV drugs, lopinavir and ritonavir; lopinavir/ritonavir plus interferon beta-1a; and hydroxychloroquine. These therapies were chosen after an assessment of evidence by an independent WHO group of experts. On this basis they were prioritized for inclusion in the SOLIDARITY trial for evaluation of their effectiveness against the SARS-CoV 2 virus, which causes COVID-19. As new evidence emerges, WHO may decide to add novel treatment arms while the trial is in progress.
Mylan is also working with selected public health institution partners currently studying potential prophylactic measures and has designated additional hydroxychloroquine doses for donation.
Mylan continues to align with government and health authority guidelines in an effort to safeguard its workforce and has activated a global COVID-19 leadership team to make assessments on an ongoing basis. While Mylan's business operations are considered essential based on government guidelines throughout the world due to the important role pharmaceutical manufacturers play within the global healthcare system, many Mylan administrative offices are currently operating under work from home protocols. Additionally, the company has taken extra precautions at manufacturing facilities to aid in the protection of site personnel and operations, including the implementation of social distancing guidelines, daily health assessments and split shifts where feasible.