* FDA seeks new trial to support efficacy of drug
* InterMune to meet FDA to explore options
* Shares down 80 pct in extended trade
(Adds analyst's comment, background, dateline)
NEW YORK, May 4 InterMune Inc ITMN.O said
U.S. health regulators refused to approve its drug to treat
lung scarring and asked for a new clinical trial to prove it
works, sending its shares down 80 percent.
A new clinical trial could keep the drug off the market for
InterMune was seeking approval from the Food and Drug
Administration for its experimental medicine pirfenidone to
treat idiopathic pulmonary fibrosis, a rare, fatal condition in
which the lungs suffer scarring due to unknown causes.
"It's pretty serious negative for the company," said
ThinkEquity analyst Brian Skorney. "They're going to need to
get more information from the FDA, but it looks like it will be
a very significant several years delay."
Investors had been expecting approval after a U.S. panel of
expert advisors to the FDA in March voted to back the drug
despite some reservations about side effects, sending InterMune
shares up some 60 percent at the time.
But Tuesday's setback sent the shares crashing back to
$9.45 in after hours trading from their Nasdaq close at
"After the positive FDA advisory committee meeting of March
9 at which the committee recommended the approval of the
pirfenidone (new drug application) by a 9-3 margin, we are
disappointed by this outcome," Chief Executive Dan Welch said
in a statement.
The company said it planned to meet with the FDA as soon as
possible to discuss the agency's concerns and pathways to
Had it been approved, pirfenidone, which was to be sold
under the proposed brand name Esbriet, would have been the
first drug to treat idiopathic pulmonary fibrosis, the
condition that killed actor Marlon Brando, daredevil Evel
Knievel and entertainer Robert Goulet.
Without treatment, pulmonary fibrosis causes breathing
difficulty and coughing that gets progressively worse over
time. Patients with the disease tend to live two to five years,
according to the company.
While the drug does not cure pulmonary fibrosis, experts
have called it an important step in helping to slow down
patients' worsening lung function.
Approval of pirfenidone is seen as critical to the small
biotechnology company. Its one marketed product, Actimmune, has
no meaningful sales.
(Reporting by Bill Berkrot; Additional reporting by Susan
Heavey in Washington and Anand Basu in Bangalore)