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 "Their lives, in short, will be transformed,"
Pharmaceutical Research and Manufacturers of America (PhRMA)
President John Castellani said at the group's annual meeting in
Washington. "The value to these patients, and to their loved ones
and society — you can't put a price tag on it."
Gilead's Sovaldi costs about $84,000 for a 12-week course of
treatment, or $1,000 a day.
That has drawn fire from health insurers, including state Medicaid
programs, as well as U.S. lawmakers who are investigating Sovaldi's
hefty price tag. This week, the World Health Organization joined the
chorus of those seeking affordability for such drugs.
While Gilead has said it is working to offer lower prices in dozens
of developing countries, critics say such treatments should cost
hundreds of dollars, rather than tens of thousands. Another
treatment from Johnson & Johnson that some doctors have been
combining with Sovaldi as other new medicines advance toward
approval, costs about $66,000.
Sovaldi, which was approved by the U.S. Food and Drug Administration
late last year, is well on track to post record-breaking sales in
its first year on the market.
Analysts with Capital Alpha have said 2014 sales of the drug could
reach up to $15 billion, a figure that would top peak sales of
Pfizer Inc's cholesterol fighter Lipitor, which had been the world's
top-selling medicine before its patent protection lapsed.
As many as 150 million people worldwide, including about 3.2 million
in the United States, have hepatitis C, which is caused by contact
with contaminated blood, often through shared needles by drug
abusers or, prior to routine blood screening, from blood and organ
transplants.
Many people can carry the virus for decades before symptoms appear.
But if untreated, it can cause serious liver damage and lead to
cirrhosis, liver cancer, the need for a liver transplant or death.
"For the first time, 150 million people who are chronically infected
with hepatitis C can be treated and cured of this terrible disease,"
Castellani said.
He said debate over the price of new anti-viral drugs to treat the
chronic condition, and the value they bring to patients, has gone
"askew," and warned that researching and developing them comes at a
high cost to manufacturers.
Defenders of the new medicines point out that older current
multi-drug regimens cost at least as much, cure about 75 percent of
patients, require 24 or 48 weeks of treatment and have miserable
side effects that lead many to delay or discontinue treatment.
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The newer medicines being developed by several companies have
demonstrated in clinical trials cure rates well in excess of 90
percent with minimal side effects and will require 12 weeks or fewer
of treatment.
Those companies, including AbbVie Inc, Merck & Co and Bristol-Myers
Squibb Co, are likely to be drawn into the pricing controversy as
their new medicines edge closer to approval amid fears that millions
of patients will now come forward to seek treatment, causing a
massive cost burden to insurers and governments.
Merck and Bristol-Myers presented new hepatitis C data on
Thursday at a major liver disease meeting in London. Gilead, AbbVie and others will also present
clinical trial data at the meeting.
"Policymakers ... need to value innovation and stop implying that
it comes cheap," Castellani said.
Foster City, California-based Gilead, which paid $11 billion to
acquire the company that had the rights to Sovaldi, has said it is
working with government officials and others to help create a
globally tiered pricing structure.
That plan includes licensing the drug to three or four Indian
generic manufacturers to allow sale of the medicine at lower prices
in some 60 developing nations.
Separately on Thursday, Indian generic drugmaker Natco Pharma Ltd
called on the government to deny Sovaldi a patent in India, a source
with knowledge of the matter said, potentially clearing the way to
launch a much cheaper version of the drug.
(Additional reporting by Bill Berkrot in New York; editing by
Matthew Lewis)
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