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

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Michael Bristow, M.D., Ph.D. Wins 2008 PhRMA Award

Congratulations to Michael Bristow, M.D., Ph.D., the S. Gilbert Blount Professor of Medicine at University of Colorado, Head of Cardiology, Co-director of the University of Colorado Cardiovascular Institute, co-founder of Myogen (acquired by Gilead (NASDAQ: GILD), founder of ARCA Discovery and now add to that list winner of the Pharmaceutical Research and Manufacturers of America (PhRMA) 2008 Discoverers Award - Clinical Trial Exceptional Services Award. The distinguished award was given for discoveries made in the early 1980’s where Dr. Bristow found the failing human heart was subjected to harmful amounts of increased adrenergic activity, and the logical therapeutic response to that activity was beta-blockade; as well as for being the Principal Investigator and Chair of the Phase II and Phase III trials for Coreg (carvedilol) where Dr. Bristow’s work also helped to characterize the receptor and molecular profiles of the drug in the human heart. Coreg a medication by GlaxoSmithKline (NYSE: GSK) was the first beta-blocker approved by the FDA for the treatment of heart failure.

PhRMA represents the country’s leading pharmaceutical research and biotechnology companies, which are devoted to inventing medicines that allow patients to live longer, healthier, and more productive lives. PhRMA companies are leading the way in the search for new cures. PhRMA members alone invested an estimated $43 billion in 2006 in discovering and developing new medicines. Industry-wide research and investment reached a record $55.2 billion in 2006.

***NOTE*** Take a look at the new Boulder Biotech Company Tree (HERE)!
***NOTE*** Read the new eBook CLSDF 2007 - What's In A Year? (HERE)!

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