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Biotech
Vs. Bacteria
A Better
Antibiotic?
Matthew Herper, 07.09.03, 7:00 AM ET
NEW YORK -
Francis P. Tally, the chief scientific officer of Lexington,
Mass.-based Cubist Pharmaceuticals, has watched antibiotic
research become eclipsed by sexier fields in drug development. Now
he is watching anti-bacterial drugs make a bit of a comeback, and
may even be leading the way with Cubist's Cidecin. If the Food and
Drug Administration OKs the drug, it will be only the second new
class of antibiotic approved in 35 years.
Tally, 63, has been an antibiotics
researcher for a quarter of a century. For nine years, beginning in
1986, he headed antibiotic research at Lederle Laboratories, a
division of what is now Wyeth (nyse:
WYE -
news -
people ), where he launched the drug Zosyn in 1993. Before that,
he was conducting antibacterial research at the Tufts School of
Medicine. But even toward the end of his tenure at Lederle, big
pharmaceutical companies were starting to pare back on antibiotics,
opting for more lucrative cancer and heart drugs. In 1995, he joined
Cubist (nasdaq:
CBST -
news -
people ), saying he hoped to design a new generation of
antibiotics to combat "super bugs"--deadly pathogens that are
resistant to just about every drug in the antibiotic arsenal.
Bacterial resistance is a serious problem.
Tens of thousands of people die each year as a result of resistant
infections. Of particular concern is a bacteria called
Staphylococcus aureus. Like other bacteria, S. aureus
mutates at random, and through trial-and-error it will eventually
find a way to outsmart any drug. But when it comes to resisting
antibiotics, it is at the head of its class. Over 70% of the
bacteria that cause hospital-acquired infections are resistant to at
least one of the drugs used to fight them.
Cubist's injectible antibiotic Cidecin
targets S. aureus and similarly resistant bugs in hospitals.
Right now, Thomas Dietz at Pacific Growth Equities predicts 2006
Cidecin sales of at least $275 million to treat skin and soft-tissue
infections in hospitals. But Dietz, who owns Cubist shares, sees
sales of at least $600 million if clinical trials testing the drug
against endocarditis, a bacterial infection of the heart, pan out.
When caused by S. aureus, the endocarditis is fatal at least
one-third of the time. "Physicians feel if you can treat
endocarditis," says Tally, "then you can treat any infection. And
there's a tremendous halo effect around that."
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Staphylococcus aureus
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But Cidecin itself is evidence of how
difficult it is to develop a new antibiotic. Tally didn't find it
using the drug technology Cubist was working on when he came aboard.
Cubist licensed the drug, generically known as daptomycin, from
Eli Lilly (nyse:
LLY -
news -
people ). Lilly will receive a complex royalty on the drug that
analysts estimate at about 14%. "Daptomycin looks to me like a very
nice drug," says Peter Appelbaum, a pathologist at Penn State
University who spends a lot of time testing drugs against resistant
strains of bacteria.
Cidecin is absolutely unique, but there
have been development snags. It failed to work well enough against
community-acquired pneumonia to be approved, apparently because the
drug it was being compared with performed much better than it
normally does. And Cidecin hit a snag at the FDA that was apparently
a result of a clerical issue. A regulatory decision was originally
expected last month, but some empty fields in the new drug
application--one of the first filed electronically--confused the
FDA's computers. A final regulatory decision will come during the
next three months, but approval is expected.
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Francis P. Tally
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Even at $600 million, the potential
market for Cidecin is small by the standards of many drug companies,
which rely on drugs with sales of well over $1 billion. And new
antibiotics have had trouble gaining a foothold, or getting onto the
market at all. Aventis' (nyse:
AVE -
news -
people ) Ketek has been held up by more than two years of
regulatory delays in the U.S. Eli Lilly and Roche seem to be
doing little if any research in the area. In the past five years,
new antibiotics from Pfizer (nyse:
PFE -
news -
people ) and Bristol-Myers (nyse:
BMY -
news -
people ) turned into major disappointments. Pfizer research
chief
Peter Corr says his company is committed to inventing new
antibiotics, pointing to a recently licensed an experimental pill
from Tokyo-based Daiichi, still in the early stages of human tests.
Other candidates are in even earlier stages of testing.
"This is an ongoing issue; this is not a
phase," says
Michael Bonney, Cubist's CEO. "In another ten or 15 years,
we're going to have the same problems. If you lose the ability to do
basic discovery research on resistant organisms, you're going to
have a major public health problem."
New incentives to help drive both small
biotechs and big pharmaceutical companies into developing bug
killers would help, but they won't come easily. "That could take an
act of Congress," Tally says. He expresses optimism that regulators
may be wising up to the fact that they've made it too difficult to
approve new antibiotics that fight dangerous infections. One
antibiotic, Factive, has already made it through the FDA this year
under the sponsorship of GeneSoft, a small company run by former
Affymetrix (nasdaq:
AFFX -
news -
people ) chief executive
David Singer. Regulatory sensitivity alone may be enough to
spur the development of more antibiotics. One way or another there
will be more resistant bugs ahead. |
