New Collaboration Will Develop, Deliver Needed Childhood TB Medicines

30 October 2013 (PARIS, FRANCE): In an effort to develop and deliver treatments for children with tuberculosis (TB)—answering a critical need in public health today—TB Alliance, a not-for-profit organization with the mission to develop better, faster-acting, and affordable drugs for TB, has entered into a collaboration with Svizera Europe, one of the leading global supply and distribution companies for TB treatments. The partnership aims to create and enable access to new medicines for childhood TB. Tuberculosis is among the top 10 killers of children and an estimated 500,000 children have TB, but many suspect the burden could be much higher.

Today, there are no quality-assured medicines available in the formulations recommended by the World Health Organization (WHO) to treat children with TB. TB Alliance has spearheaded an initiative, in partnership with WHO and primarily funded by the global health initiative UNITAID, to facilitate the development and delivery of appropriately dosed, child-friendly formulations of the “first-line” TB treatment to increase child survival and decrease the emergence of drug resistance. The partnership between TB Alliance and Svizera should advance these goals.

“Clinicians and countries don’t have the right tools to treat children with TB,” said Boudewijn Ploos van Amstel, CEO of Svizera. “We look forward to partnering with TB Alliance to not only ensure correct pediatric treatments will be developed but that they will be delivered and made accessible in high TB burden countries.”

The current first-line treatment for drug-sensitive TB is a combination of isoniazid, rifampicin, pyrazinamide, and ethambutol. In 2010, the WHO revised its recommended dosing for childhood TB medicines, in recognition that children were receiving too little drug to fully treat their disease. However, no formulations have since been developed in line with these revised recommendations. As a result, children are treated with the currently available formulations that deliver too little treatment, or existing adult formulations which are broken or crushed in an attempt to achieve the right dose. The complexity of these approaches contributes to poor outcomes and the development of drug resistance amongst children.

“TB is a neglected disease—but children with TB are the neglected of the neglected,” said Mel Spigelman, MD, President and CEO of TB Alliance. “The collaboration with Svizera Europe is an important first step toward creating the appropriate products to treat children with TB and correcting the inexcusable lack of attention to this growing problem. In turn, this partnership will help to create a sustainable market, one in which there is adequate and appropriate supply to help meet the urgent need.”

Additional work must be undertaken to ensure new treatments reach children with TB. Working with WHO, UNITAID, and others, TB Alliance will clarify the global regulatory pathway for new pediatric TB treatments as well as conduct research that analyzes not just patient numbers but the potential size of the market, gaps in programmatic implementation, barriers to market entry, and other market dynamics to help ensure a sustainable supply of appropriate, quality assured child-friendly medicines for children with TB.

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