InterMune - The Black Knight of Biotech?

Fans of Monty Python no doubt recall the exchange between King Arthur and the Black Knight early in the movie, where the Black Knight refused to back down and concede defeat no matter what damage King Arthur managed to inflict. While the FDA inflicted far more than a flesh wound on InterMune's (Nasdaq:ITMN) stock price when the agency went against its own panel's recommendation and rejected the application to market pirfenidone (Esbriet) for idiopathic pulmonary fibrosis (IBF), the company may yet win this battle. 

Europe Comes To The Defense ... Maybe
InterMune's shares soared last week on the news that the Committee for Medicinal Products for Human Use (known by the very unfortunate acronym of CHMP) recommended approval of Esbriet within the European Union. Similar to the how the U.S. system works, the CHMP serves as a buffer between the company's application and final approval, and provides recommendations to the European Medicines Agency (like panels do for the FDA).

Like in the U.S., though, a favorable opinion/recommendation does not guarantee final approval, nor the possibility of restrictive labeling. Nevertheless, it is notable that this process moved along quite quickly - CHMP could have come back to the company with a further list of questions/issues, but instead decided it had enough information to issue its recommendation. At this point, then, a final decision will come within 60 calendar days. (For more, see Measuring The Medicine Makers.)


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