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FDA Approvals of 2012

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Last year turned out to be a record-setter for new drug approvals in the U.S. The FDA blessed 39 new molecular entities (NMEs) in 2012, the most in 16 years and even more than the 35 racked up in 2011. And some experts are heralding a new era of productivity for biopharma R&D.

We'll see. Analysts at McKinsey predict that 35 approvals a year will become standard news in the industry through 2016. Compare that with the first decade of the new millennium, when an average of 24 drugs per year won FDA approval. It even beats out the 31-per-year average in the 1990s.

A new era of productivity would be--at the risk of stating the obvious--an extremely important development. The patent cliff has taken a toll on some of the industry's biggest drugs. Revenues continue to fall on those products to generic competition; governments are cranking back reimbursements; and development costs continue to rise. And while the worst of the patent cliff may be past for many companies, expirations will still take their toll. EvaluatePharma forecasts that $290 billion in sales are at risk from patent expirations between 2012 and 2018. Overall, branded drug sales were expected to fall 3.5% for 2012, according to a report from IBISWorld, and to recede about 2.6% a year for several years more. Jobs in the industry are expected to decline as sales do.

So, a stepped-up pace of new drug launches would give drugmakers more products and more sales to make up for their losses elsewhere. But is that predicted productivity a promise--or merely a hope? Development costs are way up, and pipelines are still lacking. Deloitte said last year that the cost of developing a drug had climbed 23% to more than $1 billion, while the average number of late-stage compounds in development fell to 18 from 23. And some of the industry's most anticipated products proved this year to be big disappointments, from the hepatitis C drug Bristol-Myers Squibb ($BMY) scrapped after patients died during a trial, to the very recent failure of Merck's ($MRK) cholesterol fighter Tredaptive, the third blood-lipid remedy it abandoned last year.

In fact, Tim Anderson at Bernstein Research recently reported that the Phase II success rate for experimental drugs cratered to 22% for the 5-year period ending in 2011. The success rate for the previous 5 years--2003 to 2007--amounted to 34%. Phase III was better, but that rate still fell to 65% from 70%. At the same time, the number of preclinical programs needed to produce a single new drug grew from 12 to 30.

Some experts point out that blunt numbers are only part of the picture. The big question is, how much money do all of these drugs generate? Despite its optimism about raw approval figures, McKinsey expects less on the sales side. The firm predicts "average peak-year sales of innovative products" will track down from about $900 million for the long list of products launched last year, to around $600 million for products launched in 2015.

It would be great if companies could generate more money from fewer drugs. But there are many signs that returns on investment will continue to get squeezed--and so the industry needs to not only bring costs down but also to generate even more new drugs to make up for lower per-product returns. The strategies for doing so are as varied as the drugs on this new approvals list.

The 2012 FDA approvals list runs the gamut. It includes everything from a new erectile dysfunction drug to a treatment for overactive bladder to one for weight-loss. There are nearly a dozen cancer drugs. There's one used in a test to rule out Alzheimer's disease, although none to actually treat that condition. And this is just a sampling.

There were only 4 companies that got more than one drug approved out of the 39. Forest Laboratories ($FRX), Roche's ($RHHBY) Genentech unit, and Sanofi ($SNY) got two FDA approvals in 2012. Industry leader Pfizer ($PFE), grabbed 5 of the approvals. 

As always, we welcome comments about what this list might say about the biopharma industry today--and about its future. -- Eric Palmer (email | Twitter)

Related Articles:
Special Report: Top 15 drug patent losses for 2013
New cancer drugs help spur drug approvals to 16-year high 
Deloitte: The price of R&D success soars as investment returns shrivel 
U.S. branded sales to end 2012 with 3.5% decline

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