InterMune Needs Breath Of The outdoors After FDA Rejection
The FDA has been busy this week approving Provenge for use and taking Tylenol to task, it has given InterMune a cold shot. InterMune previously had submitted a drug to treat pulmonary fibrosis for approval, and also the FDA has turned InterMune down. The drug, which is called pirfenidone, was denied by the Food and Drug Administration because it had failed to live up to expectations in a second clinical trial. To get back on board, investors had to get unsecured loans since InterMune stock went plummeting.
InterMune wonder drug is deflated by the FDA
The InterMune corporation had previously had soaring stock prices. Prices went plummeting as the FDA did not see enough evidence of efficacy in a second trial. In the last few months, the company stock had been on a high, and earlier this week had been trading at $45.44 a share, according the New York Times. After the word from the FDA, InterMune stock, designated ITMN, was sent plummeting to the bottom, losing 80 percent of its value or $36 per share.
Wonder drug to treat Pulmonary Fibrosis
This drug, pirfenidone, would treat symptoms of pulmonary fibroses, which consists of idiopathic pulmonary fibrosis. Pulmonary fibrosis is a disease which causes scarring and hardening of lung tissue. (Idiopathic means there is no known cause.) The disease is typically fatal and those who have it generally live only a couple of years after diagnosis. Esbriet would have been the trade name the drug would are sold under. The Times article indicated that the drug merely postponed death for a short period, without slowing any symptoms. Therefore, there would be dubious benefit.
Back to the drawing board
Considering the vicious nature of the disease, there were numerous who felt the FDA should are more lenient. This is not entirely bad news, as it means that InterMune will likely return to work on the drug. This may very well lead to a a lot more effective treatment than pirfenidone, which had only undergone the second round of clinical trials. Even within the first, it did not reverse the disease or damage caused by it.
Resources for the article
New York Times
http://www.nytimes.com/2010/05/05/business/05lung.html?src=busln








