Significant Reductions in Prices of HIV Medicines
Merck & Co., Inc. Announces Significant Reductions in Prices of HIV Medicines to Help Speed Access in Developing World
Merck Will Not Profit From Sales of CRIXIVAN and STOCRIN in Developing Countries
WHITEHOUSE STATION, N.J. (USA), March 7, 2001 -- Merck & Co., Inc. announced today that effective immediately, it is lowering its prices in developing countries for CRIXIVAN„¥ (indinavir sulfate) and STOCRIN„¥ (efavirenz), the Company¡¦s two antiretroviral medicines for the treatment of HIV infection. At these new prices, Merck will not profit from the sale of these medicines in the developing world.
The new prices are U.S. $600 per patient per year for CRIXIVAN and U.S. $500 per patient per year for STOCRIN in developing countries. This is the first time that a member of the class of protease inhibitors has been offered to developing countries at such a low price.
¡§Our goal is to spur efforts to accelerate access to these life-saving medications in those developing countries where the HIV/AIDS epidemic has taken such a widespread and devastating toll on the lives of those living with HIV, their families and their communities,¡¨ said Raymond V. Gilmartin, Merck¡¦s chairman, president, and chief executive officer. ¡§The epidemic also places a heavy burden on healthcare systems already under severe resource constraints. Through this action, we hope that more governments and other purchasers ¡V NGOs, private employers, and organizations who can ensure that medicines get to those most in need ¡V will invest more funding toward infrastructure and HIV care and treatment. More remains to be done by the humanitarian and healthcare communities, but by making CRIXIVAN and STOCRIN available at significantly discounted prices, Merck is stepping up our own response to the urgent humanitarian need in Africa and other regions of the developing world.¡¨
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Today¡¦s action is the third major initiative by Merck in less than a year regarding access to HIV/AIDS medicines in the developing world, reflecting the Company¡¦s efforts to find effective ways to help meet this global health challenge. Recently, through helpful dialogue with Dr. Gro Harlem Brundtland, director-general of the World Health Organization, and Dr. Peter Piot, executive director of UNAIDS, and the countries directly affected by the epidemic, Merck concluded that the most direct way to help speed and simplify access to HIV care and treatment in the developing world was to significantly lower the prices of its HIV antiretroviral medicines. Announcing these new prices publicly also simplifies the process for countries and other buyers.
New discounts for CRIXIVAN and STOCRIN in developing countries
To help spur additional efforts, effective immediately, Merck has changed its pricing policy for antiretrovirals in the developing world. In an exception to usual practice, the Company is also making the new prices public to increase transparency in addressing the global health challenge of HIV/AIDS.
At these price levels ¡V U.S. $600 per patient per year for CRIXIVAN (or U.S. $1.64 per day) and U.S. $500 per patient per year for STOCRIN (U.S. $1.37 per day) ¡V Merck will make no profit on these medicines in the developing world.
These prices apply to developing countries and will be made available to all customers (governments, NGOs, and private-sector employers) who can make the medicines accessible to patients. The only condition is that the medicines must be used in the country where they are sold, and not exported. Merck anticipates that it will be able to meet demand for the foreseeable future with existing production capacity.
Changing the access equation
CRIXIVAN, a protease inhibitor, was introduced worldwide in 1996. STOCRIN, a non-nucleoside reverse transcriptase inhibitor, was introduced in 1998. Both CRIXIVAN and STOCRIN have been available at significant discounts to developing countries since last May, when Merck joined with UNAIDS, WHO, the World Bank, UNICEF, the UN Population Fund (UNFPA), and four other research-based pharmaceutical companies (Boehringer-Ingelheim, Bristol-Myers Squibb, GlaxoSmithKline, and F. Hoffmann ¡V La Roche) in a public/private partnership to accelerate access to HIV care and treatment in the poorest countries in the world.
Since the establishment of the Accelerating Access Initiative, Senegal, Uganda, and Rwanda have reached agreement with the companies individually on more affordable antiretroviral drugs, and medicines are being shipped to these countries. More than 30 countries have made formal expressions of interest to UNAIDS, and country-led discussions continue, in cooperation with UNAIDS and the companies.
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¡§Through the framework of the Accelerating Access Initiative, Merck has had direct discussions with more than a dozen developing countries,¡¨ said Per Wold-Olsen, president of Merck¡¦s human health business in Europe, Middle East & Africa. Working together with the countries and the public sector agencies, we have gained important experience. There has been significant progress ¡V particularly on national AIDS strategies -- but patients were not getting access to medicines as quickly as we all had hoped. This experience convinced Merck of the need for more urgent action.¡¨
Improving HIV/AIDS care and treatment is more than just access to drugs
¡§Even at these new lower prices, the issue of access is not solved,¡¨ said Mr. Wold-Olsen. ¡§Antiretroviral therapy will remain out of reach for millions of people in poor countries where the epidemic¡¦s ravages are worst. In the long run, the only sustainable way to provide care and treatment for the millions of people living with HIV/AIDS in these settings is through public/private partnerships ¡V involving governments, NGOs, multilateral organizations like UNAIDS, the WHO, and the World Bank, and people living with HIV/AIDS -- to address all of the barriers to care. Most importantly, there is an urgent need for other stakeholders to do their part to increase the resources available for treatment, healthcare infrastructure, and the training of medical personnel in the developing world.¡¨
A major obstacle that faces governments and other stakeholders in addressing the HIV/AIDS epidemic in developing countries is the issue of feasibility ¡V a lack of confidence that workable models exist to really make a difference in the care and treatment of the millions living with HIV infection in developing countries. In July 2000, Merck began a partnership with the Republic of Botswana and The Bill & Melinda Gates Foundation designed to significantly improve Botswana¡¦s response to the HIV epidemic across the entire spectrum of prevention, education, care, and treatment. The goal of the Botswana Comprehensive HIV/AIDS Partnership is to demonstrate the feasibility of a targeted, comprehensive approach, from which lessons learned can be applied in other countries and similar contexts, with support from other donors.
As part of the initiative, Merck will contribute U.S. $50 million over five years toward the Botswana Comprehensive HIV/AIDS Partnership, matching the U.S. $50 million contribution from the Bill and Melinda Gates Foundation. In addition to this U.S. $50 million commitment of funds, Merck will donate CRIXIVAN and STOCRIN for treatment programs that the government of Botswana decides are appropriate to implement for the length of the initiative.
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¡§Through projects like the Botswana Comprehensive HIV/AIDS Partnership, Merck is building hope for the future,¡¨ said Mr. Gilmartin. ¡§At the same time, our primary contribution to the HIV/AIDS epidemic will be to continue to do what we do best ¡V developing breakthrough medicines and vaccines to treat and prevent HIV infection. Merck continues to invest in the search for improved HIV treatments and we are encouraged now to have an HIV vaccine candidate in early-stage clinical trials. Our commitment to research in this area is unwavering. At the same time, the discounts we have announced today to improve access to CRIXIVAN and STOCRIN will help to make a world of difference for those living with HIV/AIDS in developing countries now.¡¨
CRIXIVAN in combination with other antiretroviral agents is indicated for the treatment of HIV infection. The dosage of CRIXIVAN is 800 mg every eight hours. The indication for CRIXIVAN is based on two clinical trials of approximately one-year duration that demonstrated a reduction in the risk of AIDS-defining illnesses or death and a prolonged suppression of HIV RNA.
CRIXIVAN should not be administered concurrently with terfenadine, cisapride, astemizole, triazolam, midazolam, or ergot derivatives. Inhibition of CYP3A4 by CRIXIVAN could result in elevated plasma concentrations of these drugs, potentially causing serious or life-threatening reactions.
Merck sponsors an ongoing initiative to seek alternative, more convenient regimens using CRIXIVAN. Both twice-daily and once-daily regimens are being studied in ongoing clinical trials worldwide. Merck does not recommend any other dosing than the one shown in the label of the product.
CRIXIVAN is one of the most widely-used protease inhibitors. Some 200,000 people with HIV/AIDS in more than 80 countries are on treatment with CRIXIVAN today.
STOCRIN in combination with other antiretroviral agents is indicated for the treatment of HIV-1 infection. This indication is based on two clinical trials of at least one year duration that demonstrated prolonged suppression of HIV-RNA.
STOCRIN should not be administered concurrently with astemizole, cisapride, triazolam, midazolam, or ergot derivatives because competition for CYP3A4 by efavirenz could result in inhibition of metabolism of these drugs and create the potential for serious and/or life-threatening adverse events (e.g., cardiac arrhythmias, prolonged sedation or respiratory depression).
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The chemical entity of STOCRIN, efavirenz, was discovered by the Merck Research Laboratories in 1992 and licensed to The DuPont Merck Pharmaceutical Company (now DuPont Pharmaceuticals Company) in 1994 for development and marketing in certain countries. DuPont Pharmaceuticals Company has been granted exclusive marketing rights to STOCRIN in the United States (including its territories and possessions), Canada, United Kingdom, Republic of Ireland, France (continental only), Spain, Italy and Germany, and will market STOCRIN in those countries under its trademark Sustiva.
Merck, through its subsidiaries and marketing partners, retains the exclusive marketing rights to STOCRIN in all other countries worldwide, and will market STOCRIN under its trademark STOCRIN„· in those countries worldwide where MSD operates.
Merck & Co., Inc. is a leading research-driven pharmaceutical products and services company. Merck discovers, develops, manufactures and markets a broad range of innovative products to improve human and animal health, directly and through its joint ventures. Merck-Medco Managed Care manages pharmacy benefits for employers, insurers and other plan sponsors, encouraging the appropriate use of medicines and providing disease management programs. Through these complementary capabilities, Merck works to improve quality of life and contain overall health-care costs.
Merck & Co. is the parent company of Merck Sharp & Dohme (NZ ) Ltd.
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