R&D Pharmaceutical Industry Intensifies Efforts To Address HIV/AIDS Threat, Including Resistance & Pediatric Needs

Main Category: HIV / AIDS
Article Date: 04 Dec 2007 - 3:00 PDT

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On the important occasion of World AIDS Day on 1 December 2007, the International Federation of Pharmaceutical Manufacturers & Associations has underlined the research-based pharmaceutical industry's commitment to address HIV/AIDS. The industry's increasing R&D efforts in this area include new therapeutic approaches to provide additional treatments when resistance to established antiretroviral medicines emerges, as well as development of an increasing number of pediatric formulations. At the same time, industry programs such as the Accelerating Access Initiative are helping to increase antiretroviral coverage in the developing world.

IFPMA Director General Dr. Harvey Bale said: "Because of the novel antiretroviral medicines (ARVs) developed by the industry, HIV/AIDS has been transformed from a life-threatening condition into a manageable, chronic condition. However, as people live longer with the virus, so the chance of developing resistance to treatments grows. The industry is addressing this growing threat by developing new types of ARVs which work in new ways."

These include the recently approved first integrase inhibitor ARV(1) and a new medicine that blocks the CCR5 receptor site and has been given an approvable status.(2) In clinical trials, both have demonstrated the ability to contain HIV strains that have developed resistance to established therapies. These new products are the latest in a succession of innovative HIV/AIDS medicines that started with AZT, the first nucleoside reverse transcriptase inhibitor (NRTI), which was approved back in 1987. PIs have since been joined by non-nucleoside reverse transcriptase inhibitors (NNRTIs), protease inhibitors (PIs) and, in recent years, by a fusion inhibitor (FI).(3)

A recent survey by IFPMA's US member association PhRMA shows that the overall number of HIV/AIDS medicines and vaccines in development has increased to 92, up from 77 last year. This study only lists candidate products that have entered clinical trials, and so have reached the later and more expensive part of the overall R&D process. ARV trials currently underway which specifically address pediatric populations include those for one NNRTI (4) and one PI(5). A lower strength PI tablet has just been approved by the US FDA for pediatric use(6), which brings to 12 the number of ARVs made available in pediatric formulations(7) by the eight Accelerating Access Initiative (AAI) companies.(8)"

Data from UNAIDS shows that the number of people living with HIV/AIDS in developing countries who are receiving ARVs increased to some 2 million at the end of 2006, up from around 0.3 million at the end of 2002. Around 40% of these are receiving high-quality ARVs through the preferential price Accelerating Access Initiative program run by the companies that developed these medicines, in partnerships with UNAIDS, WHO, UNICEF; UNPF and the World Bank.

References

(1) FDA Approves New HIV Drug, 16 October 2007 (See here). This new medicine has also been approved in Canada and Mexico.

(2) FDA Approves Novel Antiretroviral Drug, 6 August 2007 (See here)

(3) Fusion inhibitor

(4) Non-nucleoside reverse transcriptase inhibitors

(5) Protease inhibitor

(6) Please see here

(7) See IFPMA Status Report: Pediatric Formulations of Antiretroviral Medicines Manufactured by Accelerating Access Initiative Companies"

(8) The AAI companies are Abbott, Boehringer Ingelheim, Bristol-Myers Squibb, Gilead, GlaxoSmithKline, Johnson & Johnson, Merck & Co., Inc. and Roche.

About the IFPMA

The International Federation of Pharmaceutical Manufacturers & Associations is a non-profit, non-governmental organisation representing national industry associations and companies from both developed and developing countries. Member companies of the IFPMA are research-based pharmaceutical, biotech and vaccine companies.

International Federation of Pharmaceutical Manufacturers & Associations