Mylan Updates Its Efforts Regarding COVID-19

HERTFORDSHIRE, England and PITTSBURGH, April 8, 2020 /PRNewswire/ -- Mylan N.V. (NASDAQ: MYL) Chairman Robert J. Coury and Chief Executive Officer Heather Bresch today provided additional detail regarding the company's continued commitment 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.

Contributing Critical Medicines to the Fight Against COVID-19

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.

Protecting Workforce Health and Safety

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, because protecting the health and safety of our workforce remains paramount, Mylan 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.

In many countries, the company has also suspended in-person interactions by customer-facing (field) personnel in healthcare settings. Field personnel in these areas have moved to a remote engagement model to ensure continued support for healthcare professionals, patient care and access to needed products. Mylan has also taken steps to protect the safety of study participants, employees and staff at clinical trial sites and ensure regulatory compliance and scientific integrity of trial data.

Supporting our Communities

Mylan has a longstanding history of giving back and supporting the communities where it operates. The company and its employees are supporting communities impacted by the COVID-19 pandemic through in-kind donations of product or personal protective gear and financial support for food pantries or other overall COVID-19 relief efforts. The company continues to work closely with its global, regional and local leaders to expand its giving initiatives over the coming weeks as needs continue to grow.

Continuing our Commitment

These truly unprecedented times require everyone in the healthcare industry to work together to meet the challenges both at hand and ahead. Mylan pledges to continue to do its part to support employees, patients, partners and communities throughout this multi-stage journey.

We thank our employees for the important work they continue to perform every day to help us deliver on our mission of providing medicines to our patients, and we send our deepest appreciation to all of the healthcare workers and first responders working tirelessly around the globe to care for those affected by COVID-19.

About Mylan
Mylan is a global pharmaceutical company committed to setting new standards in healthcare. Working together around the world to provide 7 billion people access to high quality medicine, we innovate to satisfy unmet needs; make reliability and service excellence a habit; do what's right, not what's easy; and impact the future through passionate global leadership. We offer a growing portfolio of more than 7,500 marketed products around the world, including antiretroviral therapies on which approximately 40% of people being treated for HIV/AIDS globally depend. We market our products in more than 165 countries and territories. We are one of the world's largest producers of active pharmaceutical ingredients. Every member of our more than 35,000-strong workforce is dedicated to creating better health for a better world, one person at a time. Learn more at Mylan.com. We routinely post information that may be important to investors on our website at investor.mylan.com.

Forward-Looking Statement

This communication includes statements that constitute "forward-looking statements," including with regard to the manufacture, distribution and donation of products, including hydroxychloroquine sulfate, chloroquine phosphate and lopinavir/ritonavir products; the outcome of clinical trials; timing and receipt of regulatory approvals; adjusting supply chain capabilities; and Mylan's business operations being considered essential based on government guidelines. Because forward-looking statements inherently involve risks and uncertainties, actual future results may differ materially from those expressed or implied by such statements. Factors that could cause or contribute to such differences include, but are not limited to the potential widespread and highly uncertain impact of public health outbreaks, epidemics and pandemics, such as the COVID-19 pandemic; any changes in, interruptions to, or difficulties with Mylan's or its partners' ability to develop, manufacture, and commercialize products; the effect of any changes in Mylan's or its partners' customer and supplier relationships and customer purchasing patterns; other changes in third-party relationships; the impact of competition; changes in the economic and financial conditions of the businesses of Mylan or its partners; the scope, timing, and outcome of any ongoing legal proceedings and the impact of any such proceedings on Mylan's or its partners' business; any regulatory, legal, or other impediments to Mylan's or its partners' ability to bring products to market; actions and decisions of healthcare and pharmaceutical regulators, and changes in healthcare and pharmaceutical laws and regulations, in the United States and abroad; Mylan's and its partners' ability to protect intellectual property and preserve intellectual property rights; risks associated with international operations; other uncertainties and matters beyond the control of management; and the other risks detailed in Mylan's filings with the Securities and Exchange Commission. Mylan undertakes no obligation to update these statements for revisions or changes after the date of this communication.

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SOURCE Mylan N.V.