Shares of InterMune Inc. (ITMN) surged 134 percent in mid-morning Friday trading on news that European regulators have recommended the co.’s experimental lung drug Esbriet, something the biotech failed to accomplish in the U.S. in May, when the U.S. Food and Drug Administration [FDA] declined to approve the drug that afflicts about 100,000 Americans. Shares of InterMune lost nearly 80% of their value after the FDA made its decision, trading AH to $9.47 p/sh, after finishing regular trading at $45.44.
Esbriet, a treatment for mild to moderate idiopathic pulmonary fibrosis, a fatal lung-scarring disease, has been granted Orphan Drug designation in all 27 European Union countries by the European Medicines Agency’s Committee for Medicinal Products for Human Use [CHMP], which provides 10 years of marketing exclusivity. InterMune said it could win patent protection until 2030.
“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 InterMune 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 from adoption of the CHMP opinion.
Shares of ITMN, which are currently up 130.48% to $32.88 p/sh, printed Friday the biggest rally in the R2K Index. Nearly 21 million shares have exchanged hand in less than 90 minutes into the session, compared with an average daily trading volume of 944, 000.
ITMN’s day’s range: $27.23 – $34.33. Previous close: $14.27.