InterMune ($ITMN) has succeeded in Europe where it failed in the U.S. A European panel of experts has backed the company's lung drug Esbriet (pirfenidone) for the treatment of idiopathic pulmonary fibrosis--and they handed down their decision a month earlier than anticipated. No other treatments are available for the fatal disease, which causes inflammation and scarring of the lungs. The company must now wait two to three months for the European Commission to ratify the CHMP's opinion.
In a conference call, InterMune CEO Dan Welch noted that there are about 110,000 patients who suffer from IPF in Europe--slightly more than in the U.S. The developer initially plans to focus its marketing efforts in German, France, Italy, Spain and the UK, where about 75 percent of IPF sufferers reside. Welch anticipates a mid-2012 launch of Esbriet.
In the U.S., InterMune suffered a serious setback when the FDA ruled that the developer would need to conduct a new clinical trial for the drug before approval. That decision came despite an expert panel's nine to three ruling in favor of the drug. The company has bet everything on the drug, selling all rights to hepatitis C drug danoprevir to Roche in order to stay solvent while it waited for an EMA decision. To gain FDA approval for pirfenidone, InterMune must conduct a three year, $40 million trial of the drug.
"We are very pleased by the positive opinion adopted by the CHMP, particularly because it was achieved earlier in the regulatory process than is typical," said Dan Welch. "We are now focusing our efforts on completing our commercial launch preparations to bring Esbriet to European patients as soon as possible."