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Nov 20, 2018

Mylan launches first fixed-dose combination TLD for People Living with HIV in South Africa

Mylan's TLD is the first fixed-dose combination of its kind to be offered to patients being treated for HIV

South Africa has the largest HIV epidemic in the world and is home to 19% of people living with HIV/AIDS globally1

Johannesburg, South Africa, 20 November – Global pharmaceutical company Mylan today announced the commercial launch of the first fixed-dose combination of Tenofovir Disoproxil Fumurate, Lamivudine and Dolutegravir (TLD) in 300 mg/300 mg/50 mg tablets. TLD is an antiretroviral (ARV) and will be available in South Africa as a first-line regime for people being treated with HIV/AIDS. TLD combines three of the leading first-line agents into a new, smaller tablet that patients can take once every day.

Dolutegravir is an integrase inhibitor, a class of ARVs. The high barrier to drug resistance and minimal side effects have led dolutegravir to be placed on the World Health Organization's (WHO) guidelines for the use of ARVs2. Dolutegravir in combination with Tenofovir and Lamivudine, has been listed as part of the current Southern African HIV Clinicians Society guidelines as a preferred first-line regime option3.

HIV is a public health priority for the country with 19% of the global population living with HIV in South Africa. The country also accounts for 15% of new infections and 11% of AIDS-related deaths.1

Mylan President for India and Emerging Markets, Rakesh Bamzai commented, “Mylan’s global HIV initiative is one of the key priorities of the company. The launch of TLD in South Africa reinforces our longstanding commitment to fighting HIV/AIDS and supports our mission of expanding access to high quality medicines to more people. We are proud of our progress to date in stemming the tide of the disease. More than 40% of the nearly 21 million HIV+ patients being treated today – and 60% of the world’s HIV+ children – depend on one of Mylan’s products everyday”

Mylan supplies ARV drugs to more than 100 countries around the world. In 2012, Mylan entered the South African market with a comprehensive portfolio of ARV medications, consisting of first- and second-line adult and pediatric therapies, including several dual and triple FDCs. Over the last few years, Mylan has been a significant contributor towards the treatment of the HIV epidemic in South Africa.

Mylan's Commitment to the HIV/AIDS Patient Community
Mylan is the world's largest supplier by volume of HIV/AIDS therapies. More than 40% of the 20 million patients on treatment worldwide depend on a Mylan product every day. For more than a decade, Mylan has been a leader in providing access to quality, dependable and affordable ARVs in 100 countries around the world. This includes introducing in 2009 the first generic one-tablet-once-a-day combination for developing countries – only three years after the originator product launched in the U.S. Since that time, Mylan has been the first to market with nearly half of the new products tentatively approved by the FDA under PEPFAR. Mylan was also the first generic drug maker to develop for low- and middle-income countries a heat-stable version of a drug critical for second-line regimens, and is the leading worldwide supplier of pediatric ARVs, including taste-masked and dispersible formulations. Mylan has long been a supporter of the patient community through the sponsorship of free community HIV/AIDS testing and clinical research. Watch this video to learn more about Mylan's commitment to people living with HIV/AIDS.

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 more than 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 approximately 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.

1. http://www.unaids.org/en/regionscountries/countries/southafrica
2. http://apps.who.int/iris/bitstream/handle/10665/273632/WHO-CDS-HIV-18.18-eng.pdf
3. SA HIV Clinicians Society Guidelines