USANews版 - WSJ: Hepatitis C Drug Derailed by Deal |
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发帖数: 29846 | 1 By JONATHAN D. ROCKOFF
Earlier this year, researchers reported impressive results for a treatment
that offered a potential cure for intractable cases of hepatitis C. But now,
millions of patients waiting for such a breakthrough may never get it.
The story of how the promising therapy got stalled despite positive research
illustrates a little-acknowledged truism in the pharmaceutical industry:
Sometimes drugs die not because they don't work or are unsafe, but because
they don't make business sense.
The hepatitis C treatment paired a pill from Bristol-Myers Squibb Co. BMY -2
.22% with another from a biotech called Pharmasset under an agreement struck
last year. After the successful early research, Bristol was "very keen" to
quickly move into final testing, according to Douglas Manion, a Bristol drug
-development official. But by that time, things had changed: Pharmasset had
been bought by Bristol's rival Gilead Sciences Inc. GILD +0.47% And Gilead "
declined to collaborate," said Dr. Manion.
Instead, Gilead is working on a drug regimen that pairs a pill of its own
with Pharmasset's drug. Results from a study presented Tuesday at a meeting
of liver specialists in Boston showed Gilead's combo plus a third drug cured
all 25 previously untreated hepatitis C patients a month after receiving 12
weeks of treatment.
But some doctors worry about the health of patients who are waiting for
regimens from Gilead and other companies to catch up to the therapy Bristol
and Pharmasset were working on.
"What we hope is that as quickly as possible all these therapies and
combinations can move forward because there is a large population out there"
in need of new therapies, said Paul Kwo, medical director of liver
transplantation at Indiana University School of Medicine.
Dr. Kwo, who has consulted for Bristol, Gilead and other drug makers
involved in hepatitis C research, said he wasn't taking sides. He also said
early study data for other combinations are showing cure rates comparable to
the Bristol-Gilead pairing.
Gilead said it puts the needs of patients first when evaluating drugs in
development. The drug maker declined to discuss why it wouldn't agree to a
final-stage trial with Bristol. The company said its own two-pill
combination has entered late-stage, or phase 3, testing in the most
difficult-to-treat hepatitis C patients.
"Our priority is to advance an all-oral regimen for patients as quickly as
possible, and we believe this combination allows us to rapidly move forward
toward that goal," Gilead said in a statement.
The uncertain fate of the Bristol pairing illustrates a downside of the
industry's shift toward collaboration. Companies say they are looking to
partner more, as a way to spread risks and share increasing drug-development
costs.
Drug makers agreed to partner on 72 compounds in development—in deals worth
$4 billion—during the first half of this year, according to EvaluatePharma
. But the same business reasons that foster these alliances can thwart
promising therapies as the spread of collaborations create conflicting
interests.
"We should put patients before financial interests," said Donald Jensen,
director of the Center for Liver Diseases at the University of Chicago, who
is doing clinical trial research for both Bristol and Gilead. "But this is
still a business."
Often, drug makers keep pursuing compounds in joint development despite
shifting alliances. Bristol and MerckMRK -0.81% & Co. are still developing
an anti-infective agent even though Bristol acquired Merck's partner Medarex
. Likewise, Bristol and Eli LillyLLY -0.87% & Co. successfully pursued two
additional cancer indications for the drug Erbitux after Lilly beat out
Bristol and bought ImClone Systems.
Yet promising drugs have also suffered due to changing commercial interests.
Napo Pharmaceuticals Inc. has sued Salix Pharmaceuticals Ltd., SLXP -1.98%
alleging that Salix breached an agreement to help develop a diarrhea drug
because the company has a competing treatment.
Napo alleges Salix is reneging on the deal because it would make more money
selling its own drug, rather than having to share revenue by selling the
Napo molecule. A lawyer for Salix said the allegations were "utterly without
merit, and Salix looks forward to proving that in court."
For Gilead, of Foster City, Calif., total ownership of a new hepatitis C
treatment could mean the company keeps billions of dollars in sales all to
itself. Financially, it makes sense for Gilead to avoid sharing revenue,
said Rachel McMinn, an analyst at Bank of America BAC +0.59% Merrill Lynch,
who estimates that Gilead's wholly owned combination could exceed $4.5
billion in global yearly sales. Gilead shares rose 11% this week on news
from the meeting of liver specialists.
Hepatitis C has been a subject of intense industry interest because the $5
billion global market is growing rapidly as millions of people discover they
're infected. Some 3.2 million Americans are currently affected.
Treatment consists of a weekly injection along with two different pills
taken several times a day. The yearlong regimen can be grueling, with side
effects like fever, depression and anemia. And current drugs don't work in
or can't be tolerated by about 30% of patients, doctors say.
Bristol and Gilead were among the companies looking into stronger, safer
treatments.
Both drug makers were working on a new kind of antiviral agent that tries to
prevent hepatitis C from multiplying by stopping a protein called NS5A. But
a cure is still thought to require attack with multiple drugs.
In January 2011, Bristol reached a deal to test its daclatasvir pill with
one from Pharmasset. By June, researchers were enrolling patients in a phase
2 trial.
Yet before the trial could finish, Gilead agreed in November 2011 to pay
about $11 billion for Pharmasset, beating out Bristol.
Early trial results, presented in April 2012, showed that 24 weeks' use of
the combination eliminated the virus in all 44 patients with the most
difficult-to-treat form of hepatitis C, four weeks after treatment had
stopped.
"We had never, ever imagined—even in our wildest dreams—we could treat"
hepatitis C so quickly, effectively and without serious side effects, said
Paul Thuluvath, a doctor at Mercy Medical Center in Baltimore who had six
patients test the new treatment. "I think the pharmaceutical companies have
a moral responsibility to work together and bring it to market instead of [
following] their own vested interests."
Gilead's decision to not pursue the Bristol combination has frustrated
doctors who fret the health of patients like Franco Fieramosca could
deteriorate while waiting for other treatments.
"I keep praying that these things come out pretty soon," said Mr. Fieramosca
, 73, of Dana Point, Calif. Three rounds of current drugs have failed, and
his doctors had wanted to get him in a final-stage trial of the Bristol
combo for him.
"Our hope would have been to get him into the trial rather than wait as we
are racing against the clock to get him cured," said Ponni Perumalswami, his
doctor at Mount Sinai Hospital. Doctors hope to find another trial to
enroll Mr. Fieramosca in soon.
Write to Jonathan D. Rockoff at j**************[email protected] |
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