Reuters Health Information: ANALYSIS-InterMune drug may offer big upside to Roche if aimed at liver
ANALYSIS-InterMune drug may offer big upside to Roche if aimed at liver
Last Updated: 2014-08-27
By Ransdell Pierson and Bill Berkrot
(Reuters) - Roche Holding AG's planned $8 billion purchase
of InterMune Inc is centered around hopes for blockbuster sales
of its lung drug, but the smaller company's development pipeline
may end up giving the Swiss drugmaker a far bigger bang for its
Industry analysts have forecast annual sales of about $2
billion for the pulmonary fibrosis treatment, pirfenidone, once
it gains U.S. approval, giving Roche a valuable addition to its
But the company is expected next year to begin clinical
trials of ten-fold more potent next-generation drugs that could
also treat similar damage to the liver and kidneys as well as
Success there could be a game-changer, given the unmet
medical need to treat liver and kidney scarring that can be
caused by factors such as obesity, diabetes and alcohol and drug
"Liver fibrosis is a huge, multibillion-dollar market that's
far bigger than the lung fibrosis market," said Katherine Xu, an
analyst with William Blair & Co. "It involves millions of
patients in the United States, versus 100,000."
Pirfenidone, a pill with annual sales of about $150 million
in Europe and Canada, treats a progressive scarring condition of
the lungs called idiopathic pulmonary fibrosis that typically
kills patients within a few years.
Roche announced its proposed $8.3 billion cash purchase of
InterMune on Sunday.
The two companies have barely mentioned the liver potential
of the newer formulations as they focus on unlocking the value
of pirfenidone by winning U.S. approval of the drug for lung
fibrosis. The Food and Drug Administration awarded the medicine
its "breakthrough" designation - a signal the agency sees it as
a potentially important new therapy.
The FDA approval is expected this year following large
trials that showed it prolonged patient lives. A rival drug from
privately held Boehringer Ingelheim is also expected to gain
U.S. approval this year.
While the focus has been on the potential of pirfenidone to
treat lung damage, Dr Talmadge King, chairman of the Department
of Medicine at the University of California, San Francisco, said
fibrosis is believed to occur in a similar way throughout the
body, including the heart.
"If you can get the drug to the site and slow or prevent the
process from occurring ... it has the potential to have a
positive effect in a number of organ systems, so I would assume
that that's where it's going to head in time," said King, a lung
specialist who led the large late-stage trial of pirfenidone
upon which InterMune based its U.S. marketing application.
InterMune's research chief, Scott Seiwert, said animal
studies suggest that the newer formulations of pirfenidone have
"a much milder side-effect profile."
InterMune has said trials of its potent next-generation
pirfenidone analogues could involve patients with lung, liver or
kidney fibrosis. Seiwert declined to predict what the Roche
strategy will be.
Many analysts have yet to delve into the InterMune
pipeline's potential of treating liver and kidney fibrosis.
"It's not something we've included in our valuation" of
InterMune, said Morningstar analyst Karen Andersen, given the
many failures of other drugs that have attempted to treat liver
fibrosis, and InterMune's focus on preparing for the U.S. launch
She noted that huge sales of new drugs for hepatitis C,
especially Gilead Sciences Inc's Sovaldi, "have drawn a lot more
attention to liver-related diseases."
Gilead and Biogen Idec Inc are developing injectable drugs
against pulmonary fibrosis, with Gilead also testing its drug
against liver fibrosis. But they are a few years away from
seeking approval, and Andersen predicted InterMune will be the