For years now the multibillion-dollar R&D side of the biopharma business has produced a woeful trickle of new drug approvals, forcing the industry to conduct a top-to-bottom overhaul in the way companies develop new products. And it may be working. Today a division of Thomson Reuters is saying that last year's bump in approvals is no fluke, offering some encouraging numbers that could portend a continuing surge in approvals.
The number of new drugs filed for approval last year doubled, according to CMR International's 2012 Pharmaceuticals R&D Handbook. And Reuters reports that late-stage failures slid to 45 in the last three years after hitting 53 for the stretch from 2008 to 2010.
At its heart, writes Ben Hirschler, a senior biotech writer for Reuters, the reversal is the result of the tidal shift in focus from new therapies for mass markets in favor of drugs for smaller populations of patients with a rare or "undertreated" ailment. Industrial biotech, in which whole slates of drug candidates are run through early-stage trials in hope of an occasional hit, has been replaced by a new system in which even the biggest companies are getting far more choosy about what they invest time and money on.
"There has clearly been a downward trend in R&D efficiency in the past but what we are seeing now are some indicators that may be reversing," Chris McKenna, vice president for professional services at Thomson Reuters Life Sciences, tells Hirschler. "New molecular entity output is improving and the number of projects going into clinical development is declining, which indicates the industry is moving away from a numbers game and is focusing on better-quality candidates ... we probably need a couple more years to see if it is a sustained pattern."
- here's the article from Reuters
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