Off to Phase IV for Letairis® and the Market for Volibris®

Among the core assets that Gilead (Nasdaq: GILD) acquired from Myogen in 2006 for $2.5B was Letairis® (ambrisentan), for the treatment of pulmonary arterial hypertension (PAH), which was then approved by the FDA in mid 2007. After about a quarter in the market Gilead has initiated a Phase IV, randomized, double-blind, placebo-controlled study evaluating Letairis® in patients with PAH who have failed to demonstrate an optimal response to sildenafil monotherapy (Viagra® is not just for ED ya know…). The primary endpoint of this study, known as Athena-1, is the change from baseline in pulmonary vascular resistance (the resistance to blood flow caused by constricted lung blood vessels) following 24 weeks of treatment. The long-term safety and efficacy measures will be examined for up to one year. There are additional planned follow-on Phase IV studies through 2009.

Folks around town may recall that GlaxoSmithKline (NYSE: GSK) owns the rights to commercialize ambrisentan for PAH in territories outside of the US. Recently GSK announced that the European Commission issued a marketing authorization for ambrisentan, under the trade name Volibris®, for the treatment of PAH in patients to improve exercise capacity, and the European product launch is now scheduled for 3Q08. Very exciting global news that can trace its roots back to Colorado! Naturally we will be closely tracking performance of Letairis® and Volibris® in the coming months and years

*NOTE* Feel the power of the Colorado BioScience Association (HERE)!
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*NOTE* Read the new eBook CLSDF 2007 - What's In A Year? (HERE)!

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