for DESREM™ (Remdesivir)
Mylan's Role in the Fight Against COVID-19
As a leading global pharmaceutical company, Mylan is committed to continue doing its part in support of public health needs amid the evolving COVID-19 pandemic. The company’s priorities remain protecting the health and safety of our workforce, continuing to produce critically needed medicines, deploying our resources and expertise in the fight against COVID-19 through potential prevention and treatment efforts, and supporting the communities in which we operate.
>7,500
Products Across 10 Therapeutic Categories
69
Products on WHO List of Prequalified Products
Manufactured ~5 Billion
ARV Tablets and Capsules
12
Global
R&D Centers
of the ~23.3M HIV+ Patients on Treatment Depend on one of our Products
of the World’s HIV+ Children on Treatment Depend on one of our Products
Every day, in countries around the world, thousands of dedicated Mylan employees work with the goal of helping 7 billion people. Their mission has never been more important as we confront a pandemic that has claimed lives and devastated economies on a global scale. Many of our ~35,000 employees are working in manufacturing facilities, while others have traded their desks for kitchen tables and are juggling disrupted family schedules as well as work, like so many, during this time.
Since the early stages of the pandemic, Mylan has taken numerous actions to protect the health and safety of our employees. Guided by that commitment, we have followed government directives and the advice of relevant international, national and local health authorities at every Mylan facility around the world. We have implemented social distancing measures, daily health assessments and split shifts where feasible, and regularly offer advice and support to employees working from home.
We may be standing 6 feet apart, but we are united in our commitment to fighting COVID-19 and a host of other diseases and illnesses that threaten public health.
Mylan is mobilizing its resources and expertise in the battle against COVID-19 – our disease-fighting products, our manufacturing capabilities and our global reach. We are on the frontlines of the search for an effective treatment with our participation through product donations in the World Health Organization's SOLIDARITY trial, an unprecedented global effort to investigate potential remedies.
Mylan also announced a global collaboration with Gilead Sciences to expand access to the investigational antiviral remdesivir for the potential treatment of COVID-19. By leveraging our global research and manufacturing platform, including strong technical expertise in injectable dosage forms, we will be in a position to provide product in the coming months, demonstrating an unprecedented development timeline.
Mylan has also made available 10 million doses for donation of hydroxychloroquine sulfate to the U.S. Department of Health and Human Services (HHS), through its Assistant Secretary for Preparedness and Response (ASPR), to test the drug's potential use against COVID-19.
And the company is working with other public health institution partners currently studying potential prophylactic measures.
On another front, Mylan has waived its exclusive rights to distribute its generic version of Kaletra® (lopinavir/ritonavir) antiretroviral 100mg/25mg and 200mg/50mg tablets – another investigational treatment for COVID-19. Mylan's decision to waive its rights will ease the way for other generic pharmaceutical companies to produce the antiretroviral if it is proven to be effective.
Mylan continues to make available our global R&D, regulatory and manufacturing expertise and capacity to partners who may be in need of additional resources.
Mylan signed a licensing agreement with Gilead Sciences for the commercialization of remdesivir in 127 low- and middle-income countries, subject to reviews by national regulatory bodies and the Prequalification Program of the World Health Organization (WHO). To date, Mylan has received approval of the drug for restricted emergency use in India at a price that is more than 80% less than the branded version of the drug as part of the DCGI's accelerated approval process to address urgent, unmet needs amid the evolving coronavirus 2019 (COVID-19) pandemic in that market. By leveraging our global research and manufacturing platform, including strong technical expertise in injectable dosage forms, Mylan aims to continue to make this potentially life-saving drug more affordable and available in countries where it is licensed and obtains approval to do so around the world.
Maintaining a reliable supply of pharmaceutical products is always critical, but even more so – and often more challenging -- in the midst of a pandemic. As an essential business, and with the support of thousands of dedicated employees, Mylan has taken action to avoid supply chain disruptions for critical medicines ranging from maintenance treatments for chronic conditions to ICU drugs or anti-infectives in short supply due to increased demand. We continue to maintain operations at facilities around the world and communicate with customers – all with the goal of meeting patient needs. To date, our global manufacturing platform and supply chain continue to operate without significant disruption.
In the same way that our manufacturing teams have continued delivering on our mission, our commercial team is working hard to adapt to the “new normal,” and has completed nearly 200,000 interactions with healthcare providers using various virtual tools. We will continue our commitment to customer service as we seek new ways to serve patients through this time.
Mylan has a longstanding history of giving back and supporting the communities where it operates. As the COVID-19 pandemic has continued to evolve, the company has been especially mindful of ensuring access to medicine for underserved patient populations and some of the world’s most vulnerable communities by maintaining its giving programs and by fielding additional requests related to COVID-19-related needs. Additionally, the company continues to support local giving strategies, empowering in-market business leaders to ensure the broadest impact is made toward the most pressing needs through in-kind donations of or through financial support of local causes, such as food pantries or other relief efforts. Recent examples include:
- Mylan Ireland made a financial donation to the Irish Cancer Society to help them reach patients who are afraid of seeking help during the pandemic. The team also made an emergency crisis donation to the country’s leading homeless and addiction charity.
- Mylan is contributing a significant amount from the Mylan India Corporate Social Responsibility (CSR) Fund to Prime Minister’s Citizen Assistance and Relief in Emergency Situations Fund (PM-CARES). In turn, we established a way for employees to voluntarily contribute as well.
- Mylan Morgantown's cafe team donated box lunches to staff at Sundale Nursing Home who are caring for residents amid the pandemic.
COVID-19 and HIV/AIDS
As the world's largest supplier of antiretroviral drugs, Mylan has played a leading role in the global fight against AIDS. Antiretrovirals have helped turn the tide against AIDS by suppressing the HIV virus, which attacks the body's immune system and can lead to AIDS if left untreated.
A person with a weakened immune system also has increased risk of complications from COVID-19; the Centers for Disease Control and Prevention has classified people with poorly controlled HIV as among those "at high risk of severe illness from COVID-19." That is why the World Health Organization's COVID-19 guidance includes advice that anyone taking antiretroviral drugs to suppress HIV should maintain at least a 30-day supply of the medicine. Moreover, the Global Fund to Fight AIDS, Tuberculosis, and Malaria (Global Fund) and the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR) are recommending that the programs they support use multi-month dispensing (MMD) to provide patients with 3- or 6-months of medications, to ensure treatment continuity even during measures limiting travel to prevent the spread of COVID-19.
Mylan is acutely aware that more than 10 million people living with HIV around the world depend on our antiretrovirals every day. We continue to expand production and invest in local manufacturing so that we can continue working to ensure access to antiretrovirals wherever they are needed. We are in close communication with partners like the Global Fund and PEPFAR to plan for sustained supply, and we have responded to their requests by maximizing our supply of antiretrovirals in 3- and 6-month bottles making it more convenient for people living with HIV to receive their medicines.
COVID-19 and TB
Although tuberculosis (TB) is relatively uncommon in the United States, it remains one of the top 10 causes of death worldwide and is the leading cause of death from an infectious disease, accounting for 1.5 million fatalities in 2018. Mylan has been a leader in the fight against TB through its collaboration with multiple partners.
Like COVID-19, TB attacks the lungs, putting TB patients at a higher risk from COVID-19 complications. The World Health Organization has urged healthcare professional to "urgently maintain continuity of essential services for people affected with TB during the COVID-19 pandemic." Mylan is doing its part by working to ensure that these patients are not left behind through efforts to provide an uninterrupted and affordable supply of TB drugs to the highest burden TB countries around the world.
Mylan recognizes that water is a scarce resource in many of the communities where our employees live and the company does business. We work proactively to protect water and reduce consumption. While we have made significant headway in reduction at some locations, our water usage in 2017 increased by 3.5% to 3.3 million cubic meters, due primarily to increased global production. We continually look for ways to reduce water consumption, reuse water for non-potable purposes and install technologies that ensure adequate quality wastewater.
We continue to invest in wastewater treatment facilities and look for additional improvements across our operations. For example, we recently installed a state-of-the-art, full-scale wastewater treatment system in our manufacturing facility in Galway, Ireland.- The Council of Scientific & Industrial Research (CSIR) and Mylan Announce Partnership to Advance Therapeutic Options for Management of COVID – 19
- Mylan Initiates Supply of Remdesivir in India, Under Brand Name DESREM™
- Mylan Secures Regulatory Approval for Remdesivir Lyophilized Powder for Injection 100 mg/vial in India for Restricted Emergency Use in COVID-19 Patients
- Mylan Provides Medical Equipment to Establish COVID-19 care center in Hosur, India
- Mylan and Sesame Workshop Partner to Provide Socio-Emotional Support Resources to Families Impacted by COVID-19