A run-up of new drug approvals in the last two weeks of the year pushed the FDA's record to 39 new drug sanctions in 2012, almost twice the number approved just two years ago and the highest figure the agency has seen since 1996, when 53 new molecular entities crossed the finish line.
Regulatory OKs represent a crucial industry metric, underscoring whether an industry that spends tens of billions of dollars on R&D while racking up a terrible productivity rate over more than a decade can reform itself in time to counter the loss of tens of billions of dollars in revenue from old products now facing generic competition. Two years of encouraging improvement, though, aren't enough to satisfy some longtime industry observers who want to see whether these new drugs can live up to their peak sales estimates.
"The patent exposure will be less going forward, but where there is still a little bit of uncertainty is how much better the pipelines have become and how strong the recently approved products are," Damien Conover, Morningstar's director of pharmaceutical research, tells Reuters' Ben Hirschler.
Two big trends leap out of the numbers. One-third of these new drugs approved in the last 12 months are for cancer, underscoring the big investment being made in oncology as an improved understanding of the genetics involved in the disease is opening the door to new treatments--some of which are coming down the pipeline at a relatively rapid pace.
Another big trend: New drugs for rare diseases are also making their debut, underscoring the industry's eagerness to advance high-priced therapies for small patient populations as they follow a playbook written by pioneers like Genzyme.
The approvals we're seeing now are the result of strategic shifts at Big Pharma as well as biotech dating back 5 years or more, with some smaller companies like Ariad and Ironwood going all the way through to an approval without giving up primary marketing rights. And there could be some real momentum building up as developers start making smarter choices.
"The sheer number I think support the correctness in some of the strategy shift of the pharmaceutical companies over the last number of years," Rick Edmunds, a senior partner at Booz & Co., tells Bloomberg. The rate "implies pharma growth potential to 2015 and beyond."
Slideshows: FDA approvals of 2011 | FDA Approvals of 2012
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