InterMune Investors Eager for Lung-Drug Data
InterMune investors are anxiously awaiting findings from two clinical trials that may yield the first blockbuster drug in the company's history.
Within the next week or two, the Brisbane, Calif.-based drug maker is expected to release results from two phase III studies that are testing the drug pirfenidone in patients with idiopathic pulmonary fibrosis, a progressive and fatal lung disease.
The two studies represent high stakes for InterMune and its shareholders. If successful, pirfenidone is likely to become the first drug for idiopathic pulmonary fibrosis (IPF) approved by the U.S. Food and Drug Administration. With well over 200,000 IPF patients in the U.S. and Europe, InterMune could easily transform pirfenidone into a highly profitable drug with more than $1 billion in peak sales.
A failure of the pirfenidone studies would obviously dash those blockbuster dreams and would be the second time that InterMune tried and failed to make a lasting dent in IPF. Without pirfenidone, InterMune loses its best and nearest-term shot at becoming a profitable drug company, forcing shareholders to wait years more to see if the company's nascent hepatitis C drug program pans out.
InterMune shares were up 2.3% to $11.25 in recent trading. The stock is up about almost 30% since the middle of January.
IPF is a disease marked by scarring of the lungs caused by the gradual buildup of fibrous tissue. As the fibrotic scar tissue accumulates, air sacs in the lungs lose their ability to transfer oxygen into the bloodstream. There are no effective treatments for IPF, and unless patients can undergo a successful lung transplant, they eventual die of the disease.
In 2002 and 2003, InterMune was on track to generate around $200 million annually in sales from another drug, Actimmune, which was FDA-approved as a treatment for two rare genetic diseases but garnered nearly all its sales from doctors who used the drug "off label" to treat IPF patients.
A phase III study of Actimmune in IPF patients failed in 2002, yet doctors, at InterMune's urging, continued to prescribe the drug to IPF patients. In 2006, InterMune settled a federal lawsuit that alleged the company illegally marketed Actimmune as an IPF treatment. In 2008, InterMune's CEO at the time, Scott Harkonen, was indicted for wire fraud and criminal violations of FDA law.
Today, the IPF community has largely abandoned Actimmune. The drug's sales to InterMune totaled just $27 million through the first nine months of 2008.
Enter pirfenidone. InterMune has greater confidence this time around because there is more clinical evidence to support pirfenidone as an effective treatment against IPF.
The drug is approved for IPF in Japan. Last year, Japanese drug maker Shionogi & Co. won pirfenidone's approval there based on two successful clinical studies, including one pivotal phase III study in which pirfenidone was shown to significantly slow the decline in lung function and disease progression of IPF patients compared to patients treated with a placebo. Read the full alert with links to stock quotes, etc: TheStreet.com
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