itmn (nasdaq)

[globalequitygroup]

This stock will require some deeper pockets,
but I believe there is some real potential for some decent short term gains here as the stock continues to move up in anticipation of the FDA Meeting. Do your own DD.

BRISBANE, Calif., Feb. 1 /PRNewswire-FirstCall/ -- InterMune, Inc. (Nasdaq: ITMN) announced today that the U.S. Food and Drug Administration's (FDA) Pulmonary-Allergy Drugs Advisory Committee (PADAC) is scheduled to discuss the company's New Drug Application (NDA) for pirfenidone on March 9, 2010. Pirfenidone is InterMune's investigational drug candidate for the treatment of patients with idiopathic pulmonary fibrosis (IPF).


"There is an urgent unmet need for approved medicines for patients with IPF, a uniformly fatal disease that affects approximately 100,000 Americans, with more than 30,000 new cases diagnosed annually," said Dan Welch, Chairman, Chief Executive Officer and President of InterMune. "Despite the chronic, fatal nature of this disease, which has a higher mortality rate than that of colorectal cancer, breast cancer or prostate cancer, there are currently no approved medicines to treat IPF. We are looking forward to discussing with the Committee the data supporting the safety and efficacy of pirfenidone in IPF patients."


InterMune announced on January 4, 2010 that the FDA granted Priority Review designation for its NDA for pirfenidone for the treatment of IPF. Priority Review designation may be granted by the FDA to an NDA for drugs that have the potential to offer major advances in treatment, or provide a treatment where no adequate therapy exists. Based on the Prescription Drug User Fee Act (PDUFA), the FDA has set an action date for the NDA of May 4, 2010.


About Pirfenidone

Preclinical and in-vitro evidence has shown that pirfenidone has both anti-fibrotic and anti-inflammatory effects. In February 2009, InterMune announced the results of the company's two global Phase 3 clinical trials evaluating pirfenidone for the treatment of IPF, known as the CAPACITY trials. InterMune believes that these data support the safety and efficacy of pirfenidone in IPF patients on a number of clinical measures. Prior to initiating the CAPACITY trials, data were previously presented from one Phase 3 study and four Phase 2 clinical trials in more than 400 patients which suggested that pirfenidone may positively affect lung function and disease progression in patients with IPF. In those clinical studies, pirfenidone was safe and generally well tolerated, with the most frequent side effects reported being photosensitivity rash and gastrointestinal symptoms. In October of 2008, pirfenidone was approved for use in IPF patients in Japan and is marketed as Pirespa® by Shionogi & Co. Ltd. in that country.


About IPF

Idiopathic pulmonary fibrosis (IPF) is a disabling and ultimately fatal disease that affects approximately 200,000 people 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 the treatment of IPF.