United Kingdom | Friday, 29 August 2008
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Glaxo and Synta drug gets orphan status from FDA

By William Dove
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Posted 28 January 2008 @ 02:15 pm GMT

Pharmaceutical company GlaxoSmithKline PLC and the American based Synta Pharmaceuticals have said that the US Food and Drug Administration (FDA) has granted the drug Elesclomol, orphan drug status. Elesclomol is a medicine meant to treat metastatic melanoma.

Following the decision by the FDA, Elesclomol can now begin an accelerated clinical trials programme as there are few patients with the disease and there are no adequate treatments available for metastatic melanoma

GlaxoSmithKline signed a co-development deal with Synta in October of last year to bring Elesclomol to the market. Synta can potentially earn $1 billion in development bonuses if all milestones are met, according to Thomson Financial.

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