Former President Clinton Announces New Agreements to Lower Prices of HIV/AIDS Rapid Tests and Second-Line Drugs

13/01/06:

Former President Clinton Announces New Agreements to Lower Prices of HIV/AIDS Rapid Tests and Second-Line Drugs
Agreements with Nine Companies Will Lower Prices of HIV Diagnosis and
Two HIV/AIDS Medicines by 30-50 Percent for 50 Countries
Clinton Also Confirms that Nearly a Quarter-Million People Living with HIV are Benefiting
from First-Line HIV/AIDS Drug Agreements his Foundation Announced in 2003

New York, NY – Former President Bill Clinton announced today that his foundation’s HIV/AIDS Initiative has negotiated new pricing agreements to lower the prices of HIV diagnosis and two antiretrovirals (ARVs).

Four companies—Chembio Diagnostics (U.S.), Orgenics (Israel; a subsidiary of Inverness Medical Innovations), Qualpro Diagnostics (India; in partnership with Core Diagnostics), and Shanghai Kehua (China)—will offer rapid tests for $0.49-$0.65 per test. As a result of their agreements with the Clinton Foundation, countries will be able to reduce the cost of HIV diagnosis by 50%.
Cipla (India), Ranbaxy (India), Strides Arcolab (India) and Aspen Pharmacare (South Africa)— relying on supply of active pharmaceutical ingredients from Matrix Laboratories (India)—will offer the ARV efavirenz for $240 per patient per year, and Cipla will offer the ARV abacavir for $447. These prices represent savings of more than 30% from current market rates. (The supply of efavirenz at $240 by Cipla and Ranbaxy is conditional on certain volume thresholds; for smaller orders, a surcharge may apply.)

The products and prices announced today will be available to the Foundation’s Procurement Consortium, which currently includes 50 developing countries around the world.

“ The action of these companies is another important step in the fight against HIV/AIDS,” said President Clinton. “With more than one million people on treatment in developing countries, we face a growing challenge to keep costs affordable as we reach out to millions more in need. For relatively low-cost commodities like rapid tests, the challenge is in the volumes. Widespread testing is essential to make prevention and treatment work, and making diagnosis cheaper will allow us to extend testing services to more people, more quickly.”

Over 90% of the 40 million people living with HIV in the world do not know that they are HIV-infected. Aggressively expanding testing services is critical to both prevention and treatment. In order to reach treatment targets, developing countries need to run at least 200 million HIV tests in the next four years. The rapid test prices announced today will help save tens of millions of dollars in this timeframe. For example, Brazil—which hopes to increase annual testing volume from three to seven million tests—would save more than $10 million in 2006, or 80% from original prices, by buying under these agreements.

Speaking in Harlem today, President Clinton added, “Lowering the price of second-line drugs is a major priority for my foundation in 2006. Treatment, once started, is a lifelong commitment, and over time patients move from low-price first-line drugs to second-line combinations that are at least 10 times more expensive. Keeping the global cost of AIDS treatment sustainable will only be possible if we lower the prices of these medicines.”

First-line treatment of HIV/AIDS in developing countries has relied heavily on four ARVs. These were included in original agreements announced by the Clinton Foundation in 2003, and 240,000 patients across its Procurement Consortium are benefiting today from medicines purchased under these agreements. The annual price paid for the most common first-line therapy is $136.

The drug efavirenz is used in alternative first-line treatments (in cases of toxicity from other drugs, or when use of other drugs is contraindicated), but its use triples the price of treatment. When patients become resistant to first-line treatment, it is necessary to use second-line combinations of ARVs, which, in Africa, cost 10 times or more the price of the most common first-line treatment. Abacavir is one of six ARVs used in second-line combinations recommended by the World Health Organization (WHO).

For middle-income countries, the price of second-line medicines is an additional 4-5 times higher than in Africa, and some of these, like Brazil, already spend the majority of their budgets for ARVs on just a few second-line medicines. In two years, as many as 500,000 patients around the world will be on second-line combinations, making their comparative cost a major challenge facing ongoing HIV/AIDS treatment in Africa and around the world.
Today’s agreements on efavirenz and abacavir represent a first step in the Foundation’s effort to lower the cost of second-line treatment. The Foundation is working with its current partner suppliers to reduce the costs of additional second-line medicines, and expects to add these to its agreements later in 2006. The Clinton Foundation is grateful to the Open Society Institute for its support of the HIV/AIDS Initiative’s ongoing work to make care and treatment more affordable.

Attending the announcement was Arun Kumar, Group CEO and Managing Director of Strides Arcolab, who stated, “Strides supports the Clinton Foundation’s initiative against HIV/AIDS, and we are committed to supply a comprehensive range of first-line and second-line antiretroviral drugs under our agreement which meet global quality standards at affordable prices.” Following today’s agreement, Strides will also supply first-line ARVs under Clinton Foundation agreements.

Speaking about the rapid test agreements today in New York, Larry Siebert, President and CEO of Chembio Diagnostics, said: “The missions of Chembio and the Clinton Foundation HIV/AIDS Initiative are closely aligned, and we are extremely proud to be part of this initiative.”
The Clinton Foundation is committed to providing high-quality products under its agreements. The rapid tests included in today’s deals have been evaluated by WHO and deemed to meet minimum sensitivity and specificity criteria. The ARVs included in the agreements are being submitted to WHO and/or the U.S. Food and Drug Administration (FDA). Cipla has already submitted efavirenz following bioequivalence testing conducted by a research laboratory that has been successfully audited twice by the FDA. Additional submissions are planned for the first quarter of 2006. Cipla, Ranbaxy, Strides, Aspen and Matrix are manufacturing efavirenz and abacavir at sites that have been successfully audited by WHO and/or FDA. Registration of one or more of these products has been completed in 14 countries and is pending in 23 additional countries.