Interesting news - found on Huff n'Puff

[Guest guest]

BRISBANE, Calif., Nov. 4 /PRNewswire-FirstCall/ -- InterMune, Inc. (Nasdaq:

ITMN) today announced that it has submitted an electronic New Drug Application

(NDA) with the U.S. Food and Drug Administration (FDA) seeking approval to

market pirfenidone for the treatment of patients with idiopathic pulmonary

fibrosis (IPF). Pirfenidone has been granted Orphan Drug and Fast Track

designation by the FDA, and also has been granted Orphan Drug status in Europe.

" IPF is a rapidly and uniformly fatal disease. Sadly, there are no medicines

approved for the approximately 100,000 Americans who suffer from this terrible

disease, " said Dan Welch, Chairman, Chief Executive Officer and President of

InterMune. " InterMune has dedicated almost ten years to the development of new

medicines for patients with IPF. We are very proud to have submitted the first

NDA ever submitted to the FDA for a medicine to treat IPF patients. "

About Pirfenidone

Preclinical and in-vitro evidence had shown that pirfenidone has both

anti-fibrotic and anti-inflammatory effects. Results from three adequate and

well-controlled Phase 3 studies have shown evidence of a treatment effect in IPF

patients and the compound has been safe and generally well tolerated, with side

effects including photosensitivity rash and gastrointestinal symptoms.

InterMune licensed pirfenidone from Marnac, Inc. and its co-licensor, KDL GmbH,

in 2002 and in 2007 purchased from Marnac and KDL the rights to sell the

compound in the United States, Europe and other territories except in Japan,

Taiwan and South Korea where rights to the molecule were licensed by Marnac and

KDL to Shionogi & Co. Ltd. of Japan. In October of 2008, pirfenidone was

approved for use in IPF patients in Japan and is marketed as Pirespa® by

Shionogi in that country.

About IPF

Idiopathic pulmonary fibrosis (IPF) is a disabling and ultimately fatal disease

that affects approximately 200,000 patients in the United States and Europe

combined, with approximately 30,000 new cases reported per year in each of the

United States and Europe.

IPF is characterized by inflammation and scarring (fibrosis) in the lungs,

hindering the ability to process oxygen and causing shortness of breath

(dyspnea) and cough and is a progressive disease, meaning that over time, lung

scarring and symptoms increase in severity. The median survival time from

diagnosis is two to five years, with a five-year survival rate of approximately

20%. Patients diagnosed with IPF are usually between the ages of 40 and 70, with

a median age of 63 years and the disease tends to affect slightly more men than

women. There are no medicines approved in the United States or Europe for IPF.

Kathy...fl

PF....4/07

Wtg for TX call

_________________