InterMune (ITMN) shares more than doubled in premarket trading after a European advisory panel backed the company's experimental lung drug Esbriet (pirfenidone), something the biotech failed to accomplish in the U.S.
The Committee for Medicinal Products for Human Use of the European Medicines Agency said it "adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Esbriet . . . for treatment of idiopathic pulmonary fibrosis (IPF)." Idiopathic pulmonary fibrosis is a rare, progressive and fatal lung disease.
This is a real shot in the arm for the company, which has seen its shares drop some 70% after a serious setback in May when the U.S. Food and Drug Administration declined to approve the drug. Esbriet has been granted Orphan Drug designation in Europe, which provides 10 years of marketing exclusivity.
"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 Chairman, President and CEO Dan Welch in a statement.
The committee's positive opinion will now be forwarded to the European Commission for ratification, which typically occurs within two to three months, InterMune said. Ratification results in approval for marketing in all 27 member countries of the European Union.
"IPF is among the most urgent of unmet medical needs in respiratory medicine, with no approved therapies in the EU and with survival rates as poor as many forms of cancer," said Dr. Roland du Bois, Professor of Respiratory Medicine, National Heart & Lung Institute, Imperial College, London and co-chair of the trial program. More than 100,000 Europeans suffer from IPF.
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