Price reductions of 19% for leading generic second-line regimens and new pricing for pediatric fixed dose combinations

Over 200,000 pediatric and second-line AIDS patients now benefiting from UNITAID support

April 28, 2008
Geneva, Switzerland and New York, NY

The Chairman of UNITAID's Executive Board Philippe Douste-Blazy, and the Clinton Foundation HIV/AIDS Initiative (CHAI), launched by former U.S. President Bill Clinton in 2002, today announced new agreements with generic drug manufacturers that significantly reduce the price of second-line antiretroviral drugs (ARVs) and make available six new and more affordable child-friendly formulations.

"Today's announcement is an important step in helping to save the millions of children and adults infected with HIV in the developing world who still lack access to life-saving drugs," said Former President Bill Clinton. "It is a testament to the will of governments and partners that we have been able to broaden the reach of our pediatric and second-line AIDS treatment projects so rapidly. I am proud that my Foundation is working with UNITAID to optimize the use of available resources and to more effectively serve patients."

"We are pleased to report that now over 200,000 children and adults living with HIV/AIDS are benefiting from UNITAID and CHAI support," said Mr. Douste-Blazy, "and this achievement represents a major step in our partnership to reach hundreds of thousands of additional children through 2010 and lower the price of second-line treatment.” These important agreements contribute to the rapidly expanding reach of UNITAID’s pediatric and second-line AIDS treatment projects.

In addition, UNITAID and CHAI have announced an agreement to provide a critical new zidovudine (AZT) based fixed dose combination for the price of US$ 66.

Background

In partnership with UNITAID, the Clinton HIV/AIDS Initiative (CHAI) negotiated new prices that will reduce the cost of the most widely used generic second-line regimen (tenofovir (TDF), lamivudine (3TC) and lopinavir/ritonavir (LPV/r) by 19%, compared to prices announced by UNITAID and CHAI in May 2007. The latest prices for the second-line regimen TDF+3TC+LPV/r are 16% and 46% lower, respectively, than the average market prices in low and middle-income countries. Second-line treatment is required by patients who develop resistance to first-line treatment, and currently costs five to ten times more than first-line therapy in low-income countries, limiting access for many people who need this live-saving treatment in the developing world. Nearly 500,000 patients will require these drugs by 2010.

UNITAID also announced the addition of six new formulations to its pediatric AIDS treatment project that are more convenient and easier for children to take than versions of the same drugs that were previously available. These new products include tablets, capsules and fixed-dose combinations that replace individual solutions which are difficult to dose, administer and store. In addition, Matrix Laboratories, a division of Mylan, Inc. has become eligible to supply a critical new AZT-based fixed-dose combination to the UNITAID Pediatric Program, and CHAI has negotiated a price ceiling of $66 for the AZT FDC. This AZT FDC is better tolerated than the stavudine-based FDC and is expected to available from other manufactures in 2008. At the start of 2008, the UNITAID pediatric project was supporting treatment for over 135,000 children, doubling the number of children accessing treatment since the launch of the UNITAID project in November 2006. The partnership between UNITAID and CHAI is now supporting two out of every three children on HIV treatment globally.

The latest price reductions are based on new agreements with manufacturers Aurobindo Pharma, Cipla and Matrix Laboratories, a division of Mylan, Inc., who agreed to engage in “cost-plus” negotiations to identify the lowest price based on manufacturing costs in March 2008 as part of the tender managed by CHAI.

In total, the agreements announced today include more than 40 ARV formulations. Compared to the lowest indicative rates in the most recent report of ARV prices from Medecins Sans Frontieres, the prices announced today represent an average reduction of 21%. Relative to prevailing market rates, as monitored by the World Health Organization, the prices also represent average reductions of 22% in low-income countries and 34% in middle-income countries. In the 18 months since the initiation of the pediatric and second-line HIV/AIDS projects, UNITAID and CHAI have made 11 more ARV formulations available to patients and reduced prices, cumulatively, by an average of more than 60% on pediatric and more than 30% on second-line ARVs (in low-income countries).

The public disclosure of these prices, in addition to tools like the WHO Global Price Reporting Mechanism (GPRM) are intended to assist national purchasers in future negotiations with manufacturers to achieve more equitable prices (see www.who.int/hiv/amds/price/hdd/).

CHAI will procure drugs at the prices announced today using UNITAID funds. These prices will also benefit countries that are not supported by UNITAID, through CHAI’s Procurement Consortium, which currently includes 69 developing countries in Africa, Asia, Eastern Europe, Latin America and the Caribbean. Over 1.4 million people living with HIV in Procurement Consortium member countries are benefiting from ARVs purchased under CHAI’s agreements. Based on CHAI's estimates, this represents approximately half of all adults and children on treatment around the world at the end of 2007.

CHAI issued an open invitation in January 2008 to 17 manufacturers for proposals to supply pediatric and second-line drugs to UNITAID projects this year. Several suppliers agreed to price their drugs on a “cost-plus” basis and collaborated with CHAI to lower production costs, in part by securing lower prices for key raw materials and by addressing major chemistry challenges. Manufacturers selected to participate in the project for 2008 include: Abbott Laboratories, Aurobindo Pharma, Bristol Myers-Squibb, Boehringer Ingelheim, Emcure Pharmaceuticals, GlaxoSmithKline, Cipla, Zhejiang Huahai Pharmaceutical Co., Hetero Drugs, Matrix Laboratories, a division of Mylan Inc., Merck, Ranbaxy Laboratories, F.Hoffman-La Roche, Strides Arcolab and three designated distributors for Gilead Sciences (Aspen Pharmacare, IDS, and Puerto Rico Pharma). CHAI will facilitate a similar process of competitive bidding and supplier selection for the 2009 portion of UNITAID projects, and expects to announce further price reductions by the end of 2008.

UNITAID and CHAI are committed to ensuring the quality of all products offered under their partnership. The products that will be supplied through UNITAID-funded projects meet specific quality assurance standards. These products have either already been approved by the World Health Organization and/or U.S. FDA or another stringent regulatory authority or have been submitted for review with data establishing bioequivalence, based on tests by research labs that have been successfully audited by the WHO and/or FDA. Products purchased with UNITAID funds will also be subject to routine quality control testing.

In order to assure that participating countries will be supplied with high quality drugs, UNITAID is supporting WHO Prequalification of Medicines Programme to expedite the assessment and approval of priority medicines. Since the end of 2006, 37 medicinal products have been added to the list of prequalified medicines; 16 products are priority UNITAID niche medicines for HIV/AIDS, tuberculosis and malaria.

Clinton HIV/AIDS Initiative
Since 2002, the Clinton Foundation HIV/AIDS Initiative (CHAI) has assisted countries in implementing large-scale, integrated care, treatment and prevention programs. CHAI partners with 22 countries in Africa, the Caribbean, Eastern Europe and Asia. Individual governments take the lead, and the Foundation provides technical assistance, mobilizes human and financial resources, and facilitates the sharing of best practices across projects. CHAI also provides access to reduced prices for antiretroviral (ARV) HIV/AIDS drugs and diagnostics to a total of 69 countries, which together represent more than 90 percent of people living with HIV/AIDS in developing countries. Today, 1.4 million people are receiving ARVs purchased under agreements negotiated by CHAI.

View CHAI's price list.

Learn more about pricing.