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Important Advances in Pediatric AIDS Drug Development

December 3rd, 2014

moment_quoteWorld AIDS Day saw two important announcements regarding development of much-needed pediatric AIDS drugs. This is an issue on which the Oblates and other faith-based investors in the Interfaith Center on Corporate Responsibility (ICCR) have pressed pharmaceutical companies on for years. Since most pediatric AIDS patients are in poor, developing countries, the usual market incentive for drug development does not exist. And, the development of pediatric AIDS drugs, particularly for infants, is challenging. ICCR members have actively encouraged the major pharmaceutical companies to participate in the Medicines Patent Pool, a mechanism established under the auspices of the UN to ‘pool’ patents for drugs to make existing formulations more readily available for generic production and for innovative fixed dose combinations to be developed.

On Monday, World AIDS Day, Abbvie announced a licensing agreement for lopinavir (LPV) and ritonavir (r), top World Health Organization-recommended medicines for children. The license will enable other companies and organizations to re-formulate and manufacture specially designed LPV/r and r pediatric treatments for distribution in low- and middle-income countries where 99% of children with HIV in the developing world live. [Abbvie is a spinoff of Abbott Laboratories that contains the research-based pharmaceutical business.]

On the same day, the HIV Medicines Research Industry Forum announced that the forum is joining PEPFAR, the Global Fund, and the Pediatric HIV Treatment Initiative (PHTI) in the newly established “Global Pediatric Antiretroviral (ARV) Commitment-to-Action” to accelerate innovation and save children’s lives. The initiative is designed to accelerate the development of new, high-priority pediatric ARV co-formulations for first- and second-line treatment by 2017.

Dr. Ted Bianco, Director of Innovations at the Wellcome Trust, which facilitated the dialogue among the companies and other stakeholders, said: “It is marvelous to see the coming together of the companies to be part of this multi-stakeholder effort to provide the benefit of their collective experience and expertise in HIV drug discovery and development to help address unmet medical needs in the treatment of children living with HIV.”

The industry group said in their press release that the “HIV Medicines Research Industry Forum embraces the importance of developing new pediatric ARV formulations and accelerating access to these important medicines for children in need. The Forum’s endorsement of this Global Pediatric Antiretroviral (ARV) Commitment-to-Action signals intensified commitment to this goal, both through individual company initiatives and participation in the PHTI, which will pool knowledge, talent, and resources to overcome the scientific and practical challenges to bring new formulations and combinations as soon as possible to the children who need them. The Forum will participate in the stakeholder advisory group of the Pediatric HIV Treatment Initiative and Forum member companies will participate in the technical working groups of the PHTI to help develop the formulations most urgently needed for pediatric use. (Most of the Forum companies have already concluded pediatric licensing agreements with the MPP and others are in discussions with the MPP.) The Forum’s member companies also welcome the efforts that PEPFAR, the PHTI and the Global Fund will be making to help ensure rapid and harmonized regulatory approval and rapid uptake by national HIV/AIDS program of new pediatric HIV/AIDS medicines. The Forum will also work together with PEPFAR, PHTI, and the Global Fund, along with other participating originator and generic pharmaceutical companies, to develop an Operational Framework for the Global Pediatric Antiretroviral Commitment-to-Action by March 31, 2015.”

* The HIV Medicines Research Industry Forum is a group of research-based pharmaceutical companies that have come together to support this new Commitment-to-Action. The Industry Forum includes Bristol-Myers Squibb, Gilead, Janssen (offshoot of Johnson & Johnson), Merck & Co., Inc. (known as MSD outside of North America) and ViiV Healthcare (a company focused on HIV-AIDS research established by Glaxo Smith Kline and Pfizer in 2009, and joined by Shionogi in 2012). The Forum’s goal is “to facilitate the collaborative engagement of the innovative pharmaceutical companies with other stakeholders in exploring R&D solutions to address unmet HIV treatment needs in resource-limited settings, with a priority on unmet needs in pediatric HIV treatments.”

The Forum is facilitated by the Wellcome Trust.

† The Pediatric HIV Treatment Initiative is a collaboration of UNITAID, the Clinton Health Access Initiative (CHAI), Drugs for Neglected Diseases initiative (DNDi) and the Medicines Patent Pool (MPP).

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