Biotechnology company Intermune Inc. (ITMN) cleared the penultimate regulatory hurdle, gaining FDA panel backing for its idiopathic pulmonary fibrosis drug Esbriet on Tuesday.
Idiopathic pulmonary fibrosis, or IPF, which results in a progressive scarring of the lungs with no known cause, is a rare and fatal lung disease. There are no approved drugs in the U.S. or Europe to treat IPF, a disease, which is characterized by shortness of breath. The disease affects about 200,000 people in the U.S. and Europe.
According to the National Heart, Lung, and Blood Institute, most patients are diagnosed with IPF in their 50s and 60s, and many people live only three to five years after being diagnosed. Only lung transplants have been found to be a viable treatment option to improve survival in patients with IPF.
The Pulmonary-Allergy Drugs Advisory Committee of the FDA, which reviewed the New Drug Application for Esbriet voted 9-3 to recommend approval of the drug for the treatment of patients with idiopathic pulmonary fibrosis to reduce decline in lung function. The panelists also voted 7-5 that the drug provides a "clinically meaningful benefit".
The FDA is expected to make a final decision on Esbriet by May 4. The regulatory agency usually follows the recommendations of its panels, though not mandatory. Esbriet is expected to be a blockbuster if approved.
Intermune is also seeking approval to market Esbriet for the treatment of IPF patients in the European Union and the Marketing Authorization Application for the drug was submitted to the European Medicines Agency, or EMA, last week. (March 2, 2010). Esbriet has Orphan Drug status in Europe. InterMune expects the validation process of its application by the EMA to be completed by late March. Validation of the application indicates that InterMune's application is complete and that the review process has begun. A final decision on the company's MAA for Esbriet is expected in the first half of 2011.
The drug is already approved in Japan and is marketed there as Pirespa since October 2008.
Yet another Intermune's drug in development is RG7227/ITMN-191, which is under phase IIb clinical testing for chronic hepatitis C virus infection. RG7227/ITMN-191 is a protease inhibitor and is being developed in collaboration with Swiss drug maker Roche under an agreement signed in October 2006.
Intermune expects to provide both 4-week RVR (rapid virologic response) data and 12-week EVR (early virologic response) data from the phase IIb study of RG7227/ITMN-191 late in the first quarter or early in the second quarter of 2010.
The shares have had a wild run in the past five days - rising nearly 50% to $23.30 as of Tuesday's closing price of $23.30. Trading of the stock was halted Tuesday pending the FDA panel's review of Esbriet. The stock rocketed after it resumed trading at 4.45 p.m, rising as much as 64% to over $38.
Now that Intermune's IPF drug is only a step away from approval, analysts see the company as an attractive acquisition target.
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June 05, 2026 16:18 ET A busy week for economic news flow saw a slew of reports being released that reflected the trends in the U.S. labor market. In Europe, economic growth and inflation data gained attention as the European Central Bank and Bank of England head for policy session later in the month. In Asia, the monetary policy session of the Indian central bank was in focus as the country, a major oil importer, reels under the pressures of a weaker rupee and rising inflation.