[Ip-health] Fiercebiotech on the 39 new NMEs approved by the FDA in 2012

Jamie Love james.love at keionline.org
Thu Jan 3 10:38:05 PST 2013

2012 was a bumper year for new drug approvals at the FDA.  Eric Palmer
takes a quick look at the drugs.  Jamie


Eric Palmer

FDA Approvals of 2012

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 two
weight-loss drugs. 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 5 companies that got more than one drug approved out of the
39. Forest Laboratories ($FRX), Roche's ($RHHBY) Genentech unit, and Sanofi
($SNY) got two FDA approvals in 2012. GlaxoSmithKline ($GSK) got 3
approvals in 2012; Industry revenue leader, Pfizer ($PFE), grabbed 5 of the

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

Read more: FDA Approvals of 2012 - FierceBiotech

James Love.  Knowledge Ecology International
http://www.keionline.org, +1.202.332.2670, US Mobile: +1.202.361.3040,
Geneva Mobile: +41.76.413.6584, efax: +1.888.245.3140.

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