Q&A: Rajiv Malik, Mylan

In line with the 30^th annual World AIDS Day (#WorldAIDSDay on Twitter), Pharm Exec spoke with Mylan’s President, Rajiv Malik about what progresses our society has made to fight the disease, what challenges companies face in tackling medicine delivery to developing countries, and bringing those innovations back to our own country. Mylan, specifically, focuses on fighting infectious diseases and manufactures more than 4 billion antiretroviral (ARV) tablets each year. In commemoration, the company has turned its logo red to reflect its commitment to increase access to treatment.

PE: Have we made progress as a society in the fight against HIV globally and in the US? What more needs to be done?

Rajiv Malik

RAJIV MALIK: Thanks to modern medications, HIV is no longer a death sentence, and patients who are on treatment and virally suppressed can lead long and healthy lives. Insurance companies today offer life insurance plans for people living with HIV, which was considered unthinkable 20 years ago.

Great strides have been made in making these treatments available not only in the U.S. and Europe, but also in developing countries, where 80% of people that are HIV positive live. Globally, 22 million people today are on antiretroviral therapy (ART), 10 times more than in 2005. 

Despite this progress, we are still far from UNAID’s goal of ending AIDS as an epidemic. Globally, 14 million people with HIV are not on treatment, often in the hardest-to-reach countries and populations, 1.8 million people are newly infected each year, and almost a million people a year die from AIDS-related causes. So, we are still very far from an AIDS-free generation.

There is much left to do. We need to make sure everyone at risk is tested and put on treatment early to help reduce the risk of transmission. We need to scale up access to prevention measures such as the use of pre-exposure prophylaxis. We need to ensure the removal of structural barriers that marginalize the people most at risk, and we need to erase the stigma around HIV, to make sure that we all have honest conversations about the epidemic and what it will take to end it.

PE: Why does the fight against AIDS overseas need more champions?

MALIK: While donors are critical, we need a wider set of champions. We need political champions in developing countries, to commit their own resources to scaling up the AIDS fight and to protecting the populations at risk, including LGBTQ populations that are too often the target of discrimination. We need scientific champions to advance the research that can improve how we prevent and treat-and even cure-HIV/AIDS. We need community champions to fight stigma and to provide the range of support services needed for people living with and affected by the virus.

PE: Are there ways that companies have to adapt medicine delivery in poorer countries to suit the specific need in those areas? How do companies bring innovations in these areas back to the US?

MALIK: Mylan has a special role in supplying antiretroviral medicines (oftentimes called ARVs). We are the world’s largest manufacturer of ARVs, providing treatment for more than 40% of people in the world, which amounts to more than 8 million people. Nearly all those patients are in developing countries, and we have worked hard to adapt the products developed for higher-income countries for patients and programs in low-income ones.

In developing countries, we can develop products and combinations to make treatment less complex and reduce the pill burden. For instance, HIV treatment usually involves using three or four different molecules to minimize the chance that the virus can adapt, and in those cases, patients need to take multiple products at a time. Because Mylan is able to license products from multiple originator companies, we have developed combinations that put all the molecules into a convenient single tablet.

We also have helped adapt products for the specific needs of patients in low-income countries.  For instance, in the U.S. and Europe, pediatric products often come in a syrup formulation. In developing countries, these are bulky to transport and often require refrigeration capacity that’s unavailable. To mitigate these issues, Mylan has developed a lightweight dispersible version of pediatric antiretrovirals that dissolve into a child’s food. Additionally, we just received FDA approval under PEPFAR for a version for infants: granules packaged like a sugar packet which can be mixed with water or milk for babies born with HIV.

Mylan also is intent on looking at ways to bring such innovations back to the U.S. and lowering costs for patients and payers. Our hope is to improve access to HIV treatment to generate savings for the broader healthcare system.

PE: Has there been meaningful penetration of generic or low-cost treatments into the HIV drug category in the US and/or Europe?

MALIK: Unfortunately, the answer to this question is very little. In the U.S., generic utilization among HIV medicines is about 8% by volume and less than 1% by value, which compares to 89% and 26% for the broader U.S. pharmaceuticals market.

However, this may now be changing. One of the top coverage plans in the U.S. recently announced that it would begin preferring certain HIV drugs, for instance.  While this is a good start, there is a tremendous opportunity being missed.  A rough analysis suggests that the U.S. could save $1 billion per year by using lower-cost drugs. And that’s just the low-hanging fruit – there also is an opportunity for $3 to $5 billion in savings if patients and providers began more actively adding low-cost or generic components as part of their regimens.

In Europe, the outlook for generic penetration is relatively more positive, because several widely used antiretrovirals have recently become broadly available in generic form. But the same broader logic applies as in the U.S.: while adopting generic versions of existing older therapies can provide programs with meaningful savings, the real difference would come if generics were to start being incorporated into the default treatment approach.