Merck Marks 30-Year Milestone in Commitment to Innovation and Care in HIV/AIDS

Kenilworth, NJ - Merck, known as MSD outside the United States and Canada, announced today that the company's commitment to HIV and AIDS, which started with a research and development program initiated in the mid-1980s during the early years of the epidemic, is now entering its fourth decade. To commemorate Merck's 30 years of commitment in this area, the company is launching a new effort, “Positively Committed.” The campaign highlights the company’s contributions, including the development of innovative therapies to address the unmet medical needs of people infected with HIV-1.

“The global health community has made significant progress in the fight against HIV and Merck is proud of our role in this fight, starting at the outset of the epidemic, and continuing to this day,” said Daria J. Hazuda, vice president and therapeutic area head, infectious disease and vaccines. “Although antiretroviral therapy has advanced the management of HIV-1, much work remains to be done. We will continue to collaborate with scientists, clinicians, patient advocates and the global health community as we work together towards a common goal of eradicating this disease.”

Legacy of Commitment

• In the mid-1980s, soon after the public health community first coined the term “AIDS” to describe this emerging epidemic, Merck began its HIV/AIDS research. Merck researchers were the first to describe the chemical structure of the protease enzyme, and published the findings immediately to encourage further research efforts. Merck researchers then developed CRIXIVAN® (indinavir sulfate), an HIV protease inhibitor, which was approved by the European Medicines Agency and the U.S. Food and Drug Administration (FDA) in 1996. At the time, the FDA's approval of CRIXIVAN (indinavir sulfate) was the fastest approval in FDA history.
• In 1997, Merck's clinical study of CRIXIVAN was the first to show that a combination of antiretroviral medicines could provide prolonged suppression of HIV RNA. Today, CRIXIVAN in combination with antiretroviral agents is indicated for the treatment of HIV infection.
• In 1999, Merck introduced efavirenz, a non-nucleoside reverse-transcriptase inhibitor (NNRTI), which was developed by Merck and DuPont Pharmaceuticals. Merck retained the rights to market efavirenz in select markets outside the U.S. Today, efavirenz is one of the most commonly prescribed antiretroviral therapies worldwide.
• In the early 1990s, Merck was the first to demonstrate that inhibition of the HIV-1 integrase enzyme—which is required for HIV replication—was possible, and that inhibiting the integrase protein reduced replication and spread of the virus. This research advancement led to the development of ISENTRESS® (raltegravir). In 2007, the approval of ISENTRESS introduced a new class of treatments, HIV-1 integrase strand transfer inhibitors. Today, ISENTRESS is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in patients four weeks of age and older. The use of other active agents with ISENTRESS is associated with a greater likelihood of treatment response.

In addition, since the mid-1980s shortly after the HIV virus was identified, Merck pursued one of the largest HIV vaccine research programs, culminating in a large-scale trial that illustrated the difficulty of developing a successful HIV vaccine.

Merck's research efforts today include programs to develop novel HIV treatment and prevention technologies, and collaborations on approaches to address HIV latency and eradication.

Research is only one part of our comprehensive strategy to address unmet needs in HIV. Merck also has sought to increase access to our HIV medicines, particularly in resource limited settings.

“Effective treatments for HIV-1 infection were a distant hope in the 1980s, but collaborative scientific discovery and effective advocacy have made them possible today," said Dr. Julie Gerberding, executive vice president, strategic communications, global public policy, and population health at Merck. “I'm proud that Merck is committed to sustaining our contributions to the treatment of this infection around the world.”

Addressing the Challenge of HIV/AIDS through Collaboration

Since the inception of its HIV/AIDS research program 30 years ago, Merck has recognized the global impact of HIV/AIDS in developing countries where economic, social and political factors impede access to education, care and treatment. The Merck Foundation has partnered with governments, non-governmental organizations and various other stakeholders, contributing more than $122 million over the past 15 years to support intervention programs, strengthen healthcare capacity and improve access to treatment. In addition, Merck has provided access strategies, such as differential pricing and voluntary licensing, to enhance access to treatment in these communities.

This year, Merck partnered with the Medicines Patent Pool to provide access to raltegravir for infants and children from four weeks to under 12 years of age in low- and middle-income developing countries.