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The
Half-Full Economy
Big Pharma's
Research Drought Ends
Matthew Herper, 05.28.03, 12:00 PM ET
NEW YORK - First the bad news: Last year
the Food and Drug Administration approved only 17 new molecules for
use as medicines--the lowest count in more than a decade, and down
from a high of 53 new medicines approved in 1996. The paucity of new
medicines has been costly as older drugs lose their patent
protection faster than new ones can fill their shoes. Earnings for
big-cap drug firms followed by First Albany, an Albany, N.Y.-based
investment bank, dropped 6%. "It was the worst year in a long time,"
says First Albany analyst Adam Greene.
Now the good news: Last year may have
been a low-water mark. Already new drug approvals this year are
slightly up over last year's low. Six drugs were approved by May 15,
putting 2003 two weeks ahead of 2002. Several more important
approvals could come in June, which was a completely dry month last
year. And the numbers are more impressive when protein-based drugs
such as Johnson & Johnson's (nyse:
JNJ -
news -
people ) Procrit for anemia and Amgen's (nasdaq:
AMGN -
news -
people ) Neulasta for chemotherapy-related infections are thrown
in (until recently such medicines were handled by a different part
of the FDA). In 2002, nine such drugs were approved--up from eight
the previous year.
Even better, some of the industry's biggest
names think that their research efforts may be budding.
GlaxoSmithKline (nyse:
GSK -
news -
people ) Chief Executive
Jean-Pierre Garnier says his company--long used as evidence
that mergers don't bring more productive science--is finally
starting to reap rewards from its laboratories. Pfizer (nyse:
PFE -
news -
people ) Chief Executive
Henry McKinnell thinks the industry's research laboratories
have turned the corner, promising that, "The number of new drugs
approved is going to zoom up this decade."
Pfizer plans on filing 20 new drugs with
regulators over the next five years, equaling its output during the
early-90s research boom. Among them: treatments for asthma, sexual
dysfunction, and heart disease. Glaxo, meanwhile, has tried to
revitalize its research laboratories by separating them into six
Centers for Excellence in Drug Development that compete against one
another like individual biotechs. The result: more than 45 compounds
in early clinical trials, up from 35 last year. The London-based
giant will give an overview of its most promising research later
this year.
Already, Glaxo is raising hopes for a new
kind of targeted cancer therapy. Drugs like AstraZeneca's
(nyse:
AZN -
news -
people ) Iressa and ImClone's (nasdaq:
IMCL -
news -
people ) Erbitux work by picking a single molecule and disabling
it. Glaxo's new drug hits two such targets--in theory increasing
efficacy.
Other one-time research sad sacks have
bought or invented their own lines of new drugs. Roche has
new treatments for urinary incontinence, osteoporosis, and
rheumatoid arthritis. Bristol-Myers Squibb (nyse:
BMY -
news -
people ), which spent years between drug approvals, last year
had a promising new schizophrenia medicine approved and may get an
AIDS drug onto the market this year. However, the company still gets
most of its drugs through licensing, not through its own science.
But the new drugs have not come cheaply. In
1987, drug companies spent $231 million for each new drug developed.
Now, that number is close to $900 million per drug. A decade ago,
pharmaceutical companies' combined spending on research and
development was a little more than $10 billion. Now, they spend $30
billion. Pfizer, the largest drug firm in the world, spends $5
billion by itself. Glaxo, the second-biggest, spent nearly $4
billion on R&D last year. The $130 billion poured into drug R&D
between 1996 and 2001 was more than the industry spent in the
previous 25 years.
Those stratospheric price tags make
blockbusters all the more important, and one worry is that some of
the new drugs may be only moderate hits. For instance, analysts
expect Merck's (nyse:
MRK -
news -
people ) anti-nausea drug Emend to garner well less than $500
million in sales--a market many big drug companies might have walked
away from. (It is possible the same compound could someday become a
blockbuster depression treatment.) What the drug industry needs is
another big hit like the statins--a class of cholesterol pills that
alone accounted for more than $12 billion in U.S. sales, most of it
to Merck, Pfizer and Bristol.
But finding hits first requires getting new
medicines approved. And an end to the research drought can only be
good for patients and drug companies, and the economy as a whole.
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