* Approvals in past 2 years "cause for optimism" -FDA head
* Scientific progress, better diagnostics help productivity
* Pick-up follows lean period for drug industry R&D labs
By Ben Hirschler
DAVOS, Switzerland, Jan 25 Pharmaceutical
industry productivity is improving as a more targeted approach
to drug development yields dividends and regulators offer
speedier decisions on medicines that make a real difference to
That is the view of both the head of the U.S. Food and Drug
Administration and drug company CEOs meeting in Davos this week
at the World Economic Forum.
"The products that we have approved in the last two years do
give us real cause for optimism," FDA Commissioner Margaret
Hamburg told Reuters.
A total of 39 new drugs won approval last year - a record
only beaten in 1996 - up from 30 in 2011, which itself was a
marked improvement on the 21 cleared in 2010.
The industry badly needs a winning streak after delivering
poor returns for several years due to a wave of patent expiries
on older products and a notable failure to bring enough new
drugs to market to replace them.
The advance reflects progress in understanding the basic
science of many diseases - notably some types of cancer - as
well as smarter use of tests to target treatments to specific
patient groups based on genetic profile.
"Not only have we been able to approve more new drugs that
have real benefits for patients but also classes of drugs that
signal where we are going in areas like personalised medicine,
where we've been able to use diagnostics to target
sub-populations of responders," Hamburg said.
The attitude of the FDA has also helped, according to
Novartis CEO Joe Jimenez.
"The FDA has really shifted back to a very disciplined
scientific approach to drug approvals, so we are starting to see
more drug approvals come through," he said.
These days, however, winning approval for a new medicine is
not the whole story. Drug manufacturers also have to fight hard
to win a place for their usually pricey new products on lists of
treatments covered by insurers or state health services.
The rigour of having to prove the value, as well as clinical
effectiveness, of new medicines is helping to make companies
more targeted in developing drugs that have a clear edge - even
is this involves zeroing in on small, niche markets, said Sanofi
Discovering new medicines and progressing them through the
three required stages of clinical development remains, however,
a complex business with a fair dose of serendipity.
"It's not like engineering where the iPhone 5 follows on
from the iPhone 4. Coming up with a new drug requires skill,
insight and luck," said Merck & Co Ken Frazier.
"But we are on the verge, potentially, of a new wave of
pharmaceutical innovation - and I think Merck stands to be at
the forefront of that new wave."