[e-drug] Clinton announces lower paediatric ART prices

["E-Drug" <e-drug@healthnet.org>]

E-DRUG: Clinton announces lower paediatric ART prices
----------------------------------------------------
[A Clinton Foundation
(http://www.clintonfoundation.org/cf-pgm-hs-ai-home.htm) Press release
issued today announces a 45% price reduction in paediatric ART. Interesting
is the collaboration with the new UNITAID (www.unitaid.eu). Good that there
is now a push for paediatric ART. Special paediatric FDCs at USD 5/month are very welcome! WB]


Former President Clinton Announces Breakthroughs in HIV/AIDS Treatment for
Children: 3-in-1 Pill for Less Than $60 Annually

And 45% Price Reductions for Other Pediatric Drugs

Cipla and Ranbaxy Commit to Less than $60 for New Child-Friendly Treatment

New Agreements Lower Prices for 19 Pediatric Formulations by 45% for 62
Countries

Clinton Foundation to Lead $50 Million Effort with UNITAID to Assist
40 Countries to Expand Treatment to 100,000 Additional Children in 2007

New Delhi, India - Former President Bill Clinton announced today that his
foundation has negotiated new agreements to lower the price of HIV/AIDS
treatment for children.

Cipla and Ranbaxy will price a new child-friendly product - a three-in-one
dispersible tablet that replaces individual solutions which need
refrigeration - for less than $60 per year, or 16 cents per day, for an
average child (weighing 10kg). Thanks to additional commitments by Cipla and
other suppliers, the new agreements will supply a total of 19 different
pediatric antiretroviral (ARV) formulations for prices that are, on average,
45 percent less than the lowest rates available today in low-income
countries. The new prices will be available to the foundation's Procurement
Consortium, which currently includes 62 developing countries in Africa,
Asia, Latin America and the Caribbean.

The new prices have been made possible by UNITAID, the international drug
purchase facility established in September by France, Brazil, Chile, Norway
and the UK. UNITAID will provide the Clinton Foundation HIV/AIDS Initiative
(CHAI) with $35 million in the next year to buy medicines and diagnostics,
and CHAI will contribute $15 million more for technical assistance, to work
with 40 countries to treat more than 100,000 additional HIV-positive
children in 2007.

"Though the world has made progress in expanding HIV/AIDS treatment to
adults, children have been left behind. Only one in 10 children who needs
treatment is getting it," said President Clinton. "I applaud the commitments
that Cipla, Ranbaxy and others have made to lower the price of the drugs we
need to treat children, and I thank UNITAID for the new funds that have made
these prices possible."
French Foreign Minister Philippe Douste-Blazy, chairman of the UNITAID
board, added, "No child should have to live with HIV, but every one who does
deserves a full life. Pediatric drugs should be affordable and easy to
administer. That has been an early goal of UNITAID, and we are pleased that
our partnership with President Clinton will now make this possible."

President Clinton and Minister Douste-Blazy made today's announcement at the
Kalawati Saran Children's Hospital in New Delhi, where they joined Sonia
Gandhi to launch the Government of India's national program to treat
HIV-positive children. The program aims to increase the number of children
on treatment - from less than 2,000 in September to 10,000 by the end of
March - by making pediatric care available at all adult treatment centers in
the country. These children will be initiated on treatment with medicines
procured with resources from UNITAID. CHAI is supporting the Indian National
AIDS Control Organization to implement the program.

Cipla and Ranbaxy's pediatric fixed-dose combination (FDC) tablets include
three ARVs - lamivudine, stavudine and nevirapine - used commonly for
first-line treatment. These FDCs can be split in half and dissolve fully in
water, making them suitable for use even in young children. The dosing of
these FDCs, depends on the patient's weight, and according to the dosing
recommended by the companies, the average price from the two companies for a
child weighing 10kg is less than $60. The World Health Organization (WHO) is
developing international guidelines on pediatric FDC dosing which may be
different to those that are recommended by the manufacturers. Cipla and
Ranbaxy are committed to adapting their products as necessary to comply with
these guidelines, when finalized.

In total, CHAI will use funds from UNITAID to purchase 10 ARVs in 21
different pediatric formulations. The reduced prices announced today for 19
of these formulations reflect partnerships between CHAI and Cipla and
Ranbaxy as well as commercial agreements with other manufacturers. In
response to an open invitation issued to 14 manufacturers, Cipla and Ranbaxy
agreed to supply pediatric formulations for deeply discounted prices. CHAI
also expects to purchase ARVs from Abbott, Aurobindo, Bristol Myers Squibb,
Merck, Roche and others, based on responses to its invitation and the needs
of partner governments.

In addition to the three ARVs included in the pediatric FDC, the other ARVs
for which CHAI has negotiated price reductions include abacavir, didanosine,
efavirenz and zidovudine. The 45% average price reduction for the 19
formulations of these drugs is based on a comparison of the newly agreed
prices to the lowest prices previously available to low-income countries
from generic or originator companies. The prices under the new agreements
will represent even larger reductions - more than 70%, on average - compared
to current prices being paid by middle income countries in regions such as
Latin America and South East Asia.

CHAI will also use UNITAID funds to supply laboratory instruments and tests
for HIV/AIDS diagnosis and monitoring, including rapid tests, CD4 tests and,
for infant diagnosis, DNA PCR and RNA PCR. CHAI will also supply the
antibiotic cotrimoxazole and ready-to-use therapeutic food (RUTF). Studies
show that the preventative daily use of half a tablet of cotrimoxazole can
reduce HIV-related mortality in young children by more than a third. RUTF is
used to treat severe and acute malnutrition; it also helps to improve the
response to treatment and to reduce toxicities associated with ARV use.

CHAI is partnering with 40 governments to supply these products with UNITAID
support. In addition, CHAI and its partner governments will depend on the
contributions of other technical and funding partners, including UNICEF, the
Global Fund to Fight AIDS, Tuberculosis and Malaria and the U.S. President's
Emergency Plan for AIDS Relief (PEPFAR). In addition to pediatric treatment,
prevention of mother to child transmission of HIV is a priority in the fight
against AIDS. CHAI supports programs that offer a combined approach that
links prevention of pediatric HIV infection to treatment and care for both
parents and children.

CHAI is committed to providing high-quality products under its agreements
with manufacturers. The products included in today's agreements meet the
quality assurance standards of the Global Fund, which prioritize
prequalification by the WHO and/or approval by the U.S. Food and Drug
Administration (FDA) or other stringent regulatory authority. Twelve of the
19 formulations included in the agreements being announced today have been
approved by the WHO and/or FDA for one or more supplier(s). The remaining
products have been submitted for review. These submissions include data from
bioequivalence testing conducted by research laboratories
that have been successfully audited by the WHO and/or FDA. CHAI will only be
purchasing ARVs that are eligible according to the quality assurance
standards of the Global Fund, standards that UNITAID has also adopted.

BACKGROUND ON THE CLINTON FOUNDATION HIV/AIDS INITIATIVE

Since 2002, the Clinton Foundation HIV/AIDS Initiative has assisted
countries in implementing large-scale, integrated care, treatment and
prevention programs. It partners with 25 countries in Africa, the Caribbean
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 HIV/AIDS drugs and diagnostics to a
total of 62 countries, which together represent more than 90 percent of
people living with HIV/AIDS in developing countries.
CHAI relies on hundreds of part-time and full-time volunteers and paid
staff. There are presently more than 500 people in developing countries and
the U.S. working for CHAI. Ira C. Magaziner serves as Chairman of the
Clinton Foundation HIV/AIDS Initiative.
For his leadership in the fight against HIV/AIDS, President William J.
Clinton has been honored with the Jimmy and Rosalynn Carter Award for
Humanitarian Contributions to the Health of Humankind from the National
Foundation for Infectious Disease as well as the 2005 Pasteur Foundation
Humanitarian Award.

CONTACT INFORMATION FOR PRESS INQUIRIES
For the Clinton Foundation - New York Office: +1 212 348 0360
For Cipla - Mr. Shailesh Pednekar: +91 98 2060 9408
For Ranbaxy - Mr. Sandeep Juneja: +91 98 1180 7770
For UNITAID - Mr. Denis Simonneau: +33 1 4317 5209