Merck has had an intensive, broad-based HIV clinical research program since 1985 that has sought to address both treatment and prevention.

In addition to our own research efforts, we also have entered into collaborations with other researchers and scientific organizations to help accelerate the search for new treatments and possible cures.

Timeline of Merck's HIV Research Efforts

• In 1989 Merck scientists established the role of protease in the HIV life cycle, were the first to publish the crystal structure of HIV protease shortly thereafter, and were among the first to discover and develop medicines for the treatment of HIV.
• In 1996 Merck introduced CRIXIVAN^® (indinavir), a protease inhibitor. Merck also developed efavirenz, a non-nucleoside reverse transcriptase inhibitor.
• Beginning in 1999, Merck sought registration for efavirenz as STOCRIN^® in many countries around the world.
• Merck's work in the early phase of HIV research played an important role in collaboration with others in defining the principles for combination antiretroviral (ARV) treatment to suppress the virus to undetectable levels.
• In 2006, a partnership between Merck, Bristol-Myers Squibb and Gilead to develop a once-daily, single-tablet regimen HIV treatment resulted in the approval in the U.S. of ATRIPLA^® (tenofovir, emtricitabine, efavirenz). ATRIPLA is marketed by Bristol-Myers Squibb and Gilead in the United States, Canada and Europe. Merck is working to register and distribute ATRIPLA in many developing countries around the world.
• In 2007, Merck's efforts to address the growing problem of multidrug resistance led to the approval in the U.S. of ISENTRESS^® (raltegravir), the first integrase inhibitor and the first ARV treatment to target the integrase enzyme, one of the components the HIV virus needs for replication. ISENTRESS offers patients a different way to target the HIV virus as part of a treatment regimen.
• Merck continues to focus on comprehensive research and development that targets HIV, recognizing the need for new methods to address the epidemic. Merck's current R&D work in HIV includes basic research on HIV neutralizing antibodies, programs to develop novel HIV-prevention technologies, new HIV antiretroviral medicines and new drugs targeting HIV latency.

Preventing HIV through Microbicides

To help find new ways to prevent and treat HIV/AIDS, in 2008 Merck granted the International Partnership for Microbicides (IPM) a non-royalty-bearing, nonexclusive license to develop, manufacture and distribute a novel ARV compound (L'644) for use as a vaginal microbicide to help protect women in developing countries. The compound, the fourth we have licensed to IPM, is a member of a class of ARV molecules known as fusion inhibitors, which inhibit HIV infection by preventing the virus from fusing with the surface of target cells—an early step in the HIV infection process—potentially representing a novel way to block infection. Merck is also collaborating with IPM to advance early-stage product development research efforts. This recent agreement follows a similar IPM-Merck agreement announced in 2005.

Merck deserves recognition for its exemplary commitment to HIV-prevention research. This arrangement helps IPM pursue development of compounds that target HIV at many points in the virus life cycle. We're working toward the day when millions of women around the world will have access to safe and effective microbicides—and partnerships like this will help us get there.

Dr. Zeda Rosenberg
CEO of IPM

Stakeholder Engagement to Advance Merck's R&D Efforts

Merck regularly communicates, interacts and collaborates openly with scientific leaders in the HIV/AIDS field to advance science. In the United States, for more than a decade, Merck has had an established physician advisory board that includes international and national scientific leaders. This advisory board meets with Merck regularly to discuss and advise Merck on HIV research and development strategy, emerging scientific issues and clinical program design. At the international level, Merck has also established a similar advisory board with international scientific and clinical leaders worldwide to gain input on emerging challenges in HIV care in developing countries.

New Research Efforts to Eradicate HIV

In July 2011, Merck announced that several company researchers will participate in two new collaborative efforts led by the prominent academic institutions of the University of North Carolina (UNC) Chapel Hill and the University of California San Francisco (UCSF) to develop new approaches towards eradicating HIV, the virus that causes AIDS. UNC, researchers from nine additional U.S. universities and Merck scientists are studying HIV latency and identifying ways to purge persistent infection of the virus from the body. Separately, researchers at UCSF are working with an international team of academic, government and Merck scientists on a five-year research effort to define HIV's reservoirs, better understand the reservoirs and test potential treatments. The National Institute of Allergy and Infectious Diseases (NIAID), part of the NIH, is the primary funding organization for both of these research efforts. Merck does not receive any funding for participation in either effort.

Collaboration has been the hallmark of much of the progress made against HIV since the virus was first identified 30 years ago. Continued collaboration is absolutely essential to better understand HIV reservoirs and identify potential approaches to the daunting challenge of eradicating HIV. Merck is honored and excited to participate in these important new undertakings.

Daria Hazuda, Ph.D.
Vice President, Merck Research Laboratories