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Dec 1, 2017

Mylan Joins the Battle to Prevent HIV Infection in the World’s Biggest Pre-exposure Prophylaxis (PrEP) Trial

HERTFORDSHIRE, England, and PITTSBURGH – 1, December, 2017 – This World AIDS Day, 1st December, Mylan is proud to be supporting the NHS in delivering a pioneering new approach in the battle against HIV - the world’s largest pre-exposure prophylaxis (PrEP) implementation trial[1] targeting an estimated 10,000 people at high risk of HIV infection.

Whilst HIV infection rates in England are falling due to increased prevention, earlier diagnosis and improved treatment programmes, HIV remains a serious public health concern, with 5,164 new HIV diagnoses in the UK in 2016[2] and an estimated 10,400 people living with undiagnosed HIV infection[3]. This major new NHS-England funded 3-year trial is designed to assess the full additional potential of PrEP by gathering clinical evidence on optimal targeting, update and implementation on a large scale.

Sexual health clinics in London, Brighton, Manchester, Liverpool and Sheffield have begun to enroll people in the trial already, with further cities expected to participate in 2018.

Mylan was chosen as the sole provider of antiretrovirals (ARVs) for the PrEP trial, after winning an internationally competitive tender. Focused on extending patient access to critical treatments and already a global leader in the provision of ARVs, Mylan’s selection as drug provider for the trial further highlights its ability to provide high-value, high-quality medicines as well as its commitment to both the treatment and now the prevention of HIV.

President of Mylan Europe, Jacek Glinka, commented: “The impact of this complex illness has been widespread and devastating; more than 70 million people have been infected and 35 million have died from HIV since the epidemic began[4].

“We all know the saying ‘prevention is better than cure’ and this is never more true than when we discuss HIV and AIDS. The NHS PrEP trial offers hope, not only to those participating in the trial, but for the millions around the world who stand to benefit from the results. While treatment for those living with HIV is crucial, the importance of breaking new ground with preventative medication to reduce infection rates can’t be underestimated. We see this trial as a huge step forward in the battle against HIV and are delighted to be involved.”

Mylan is globally active in the fight against HIV and AIDS. Its journey began in 2003, when Nimmagada Prasad, an executive at Matrix Laboratories (which later became part of Mylan), met a man on an airplane who explained that his job was to secure land for new cemeteries to accommodate the rising number of people dying from AIDS in Africa. Many were unable to access expensive, but life-saving treatment. Prasad immediately galvanised his team, challenging them to create a cost-effective ARV to help ensure that the low-income people of Africa would have access to the medicines they desperately needed. Six months later, a viable alternative to existing treatments at a fraction of the cost was ready for use.

Since then, Mylan has remained committed to supporting the global fight against AIDS and HIV. We were the first generic company to launch for the developing world a one-pill-once-a-day treatment that is currently the World Health Organization’s recommended treatment regimen, and, in 2017, we were again the first company to launch for the developing world the next generation product. Approximately 40% of people on treatment for HIV around the world use a Mylan product every day.

In the UK, Mylan has been supplying the NHS with generic ARVs since 2012, with a portfolio of 10 products, supplying 40% of the NHS requirements.[5]

HIV / AIDS statistics:

UK

  • 88,769 people live with HIV in the UK[6]
  • It is estimated that approximately 12% of cases in the UK are undiagnosed[7]
  • 42% of diagnoses in 2016 were late[8]
  • 6,095 people in the were diagnosed in 2015; a rate of 11% new cases compared to 6.3% across Western Europe[9]
  • 5,146 new cases of HIV infection were reported in 2016 - a decline of 18%[10]

Globally

  • In 2016, 1 million people died from HIV across the world[11]
  • There has been a global decline in new cases since 2015[12]
  • In 2016, a new milestone was reached as more than half (53%) of those diagnosed with HIV have access to treatment[13]
  • In 2016, 19.5 million people living with HIV received ARV treatments – up from 17 million the previous year[14]

Mylan

  • 40% of all people being treated for HIV/AIDS around the world receive a Mylan product
  • Mylan produces 4 billion ARV tablets and capsules every year
  • Mylan is the world’s largest producer by volume of ARV drugs
  • Mylan has invested $250 million in expanding its ARV production capacity
  • In 2009, Mylan introduced the first generic one-tablet-once-a-day combination at less than half the price of the originator drug. Since then Mylan has continued to cut the price for the developing world markets and its ARV is now less than a quarter of what it was at launch
  • Mylan was also the first generic manufacturer to develop a heat-stable version of second-line ARVs, which are critical to markets in developing countries

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 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.



[4] World Health Organisation http://www.who.int/gho/hiv/en/

[5] IMS data

[12] .UNAIDS (2017) 'Fact Sheet 2017'

[13] .UNAIDS (2017) 'Fact Sheet 2017'