The Burrill Report


The overall rate of success for drugs reviewed for U.S. Food and Drug Administration approval is lower than previously thought, according to a comprehensive study conducted by the Biotechnology Industry Organization and the research firm BioMedTracker.

The analysis showed that just one in seven drugs secured FDA approval for lead indications, while just one in 30 drugs were successful in achieving approval for secondary indications.

“Strikingly, oncology drugs have the toughest time making their way through the clinic, despite cancer being the most closely studied area in drug development,” says Michael Hay, senior biotechnology analyst at BioMedTracker. The firm’s analysis found that 19 percent of head and neck cancer drugs reviewed by the FDA are approved, while a thin two percent of medicines for non-small-cell lung cancer get a green light for marketing.

The study, presented at the 13th Annual BIO CEO & Investor Conference in Washington D.C., examined data on more than 4,500 drugs in BioMedTracker’s database. Based on data from drugs in any stage of development between October 2003 and December 2010, it found that large molecule drugs are nearly twice as successful at gaining approval than small molecule drugs, with 26 percent of biologics achieving approval while just 14 percent of new molecular entities are approved overall.

Alan Eisenberg, EVP of emerging companies and business development at BIO, said the study underscored the depth and breadth of risk inherent in the drug development process more comprehensively than previous studies. “Knowing more about the magnitude of risk,” he says, “can lead to smarter drug development as well as smarter investing.”






February 18, 2011
http://www.burrillreport.com/article-failure_is_the_norm.html