By Bill Berkrot
NEW YORK, May 27 (Reuters) - Drugmakers are renewing efforts
to develop medicines to fight emerging antibiotic-resistant
bacteria, but creating new classes of drugs on the scale needed
is unlikely to happen without new financial incentives to make
the effort worth the investment, companies and industry experts
said.
American military researchers on Thursday announced the
first U.S. case of a patient with an infection found to be
resistant to the antibiotic colistin, the drug often held in
reserve for when all else fails. ID:nL2N18N1VN
That put a spotlight on the urgent need for new medicines
that can combat what health officials have called "nightmare
bacteria."
Drugmakers on Friday acknowledged that in the absence of a
new way of compensating them, it simply does not make economic
sense to pour serious resources into work on new antibiotics.
"The return on investment based on the current commercial
model is not really commensurate with the amount of effort you
have to put into it," said David Payne, who heads
GlaxoSmithKline PLC's GSK.L antibiotics drug group.
Other pharmaceutical companies expressed a similar
sentiment.
In January, some 80 drugmakers and diagnostics companies,
including Pfizer Inc (NYSE:PFE) PFE.N , Merck (NYSE:MRK) & Co MRK.N , Johnson &
Johnson JNJ.N and Glaxo, signed a declaration calling for
cooperation among governments and companies to create incentives
to revitalize research and development of new antibiotics.
It proposed a new business model in which profit would not
be linked to higher sales. For example, governments and health
organizations could offer lump-sum rewards for development of a
successful new antibiotic. A British government panel suggested
this month that drug companies be offered up to $1.5 billion for
successful development of a new antibiotic.
In the United States alone, antibiotic-resistant bacteria
causes 2 million serious infections and 23,000 deaths annually,
according to U.S. health officials.
Unrestrained overuse of current antibiotics by doctors and
hospitals, often when they are not needed, and widespread
antibiotic use in food livestock have contributed to the
evolution of antibiotic-resistant bacteria.
But in recent years, major drugmakers have poured most of
their research dollars into highly profitable medicines to fight
cancer, rare diseases and hepatitis C. These drugs not only
command high prices, they also are typically used far longer
than antibiotics.
And the companies, which have come under intense criticism
in recent months for continually raising prices on popular
drugs, say it costs about as much to develop a new antibiotic as
it does to bring to market new cancer drugs that can command
more than $100,000 a year per patient.
"Drug companies can't make an economic case for investing in
superbug drugs," said Erik Gordon, a professor at the University
of Michigan's Ross School of Business.
Gordon said governments and foundations need to get more
involved in research and funding to spearhead efforts to combat
the problem.
To critics who argue that U.S. companies have enormous cash
reserves that could be used to address a public health crisis,
drugmakers say they have a fiduciary duty to shareholders to
maximize profits.
ON THE R&D FRONT LINES
One reason companies are calling for alternative
compensation is that aggressive sales and use of new antibiotics
could help create ever more dangerous bacteria that develop
resistance to the new medicines.
Glaxo and Merck are among the large pharmaceutical companies
developing new antibiotics they hope can beat back resistant
bugs, while Pfizer is working on vaccines aimed at reducing the
need for their use.
Industry experts said small, lesser-known companies with
promising approaches to tackling resistant superbugs included:
Entasis Therapeutics, an AstraZeneca PLC spinoff, Tetraphase
Pharmaceuticals Inc TTPH.O ; and Achaogen Inc AKAO.O .
"We believe plazomicin, our lead drug in late-stage
development, has the potential to play an important role in
treating this dreaded superbug," Achaogen Chief Executive
Kenneth Hillan said.
Allan Coukell, an antibiotics expert at the Pew Charitable
Trusts nonprofit research and policy organization, said what is
needed is a wave of new drugs based on new chemistry or that
work in new ways.
"Most of what's being developed are variations on drugs that
we've had for decades," Coukell said.
Pew has outlined what its calls a scientific roadmap to
create a body of work around new drug discovery that companies
and academic researchers could draw upon to help jumpstart the
process of finding new antibiotics.
Glaxo said its experimental antibiotic gepotidacin, in
midstage testing, belongs to an entirely new class of
antibacterials.
"Based on that, we're predicting it would work against
infections that could be caused by bacteria that are resistant
to available antibiotics," Payne said.
Other companies with late-stage studies underway for
antibiotics include: Cempra Inc CEMP.O , whose drug was
recently validated in a Japanese trial; Medicines Co MDCO.O ;
and Paratek Pharmaceuticals Inc PRTK.O . J&J is also putting
money into battling antibiotic resistance.
"If there is a bright side, it is that the world
policymakers and health leaders have focused on this issue like
never before," Coukell said. "But we've got a long way to go."