Pirfenidone will make or break InterMune

Brisbane, CA-based InterMune (ITMN) has sold all rights to its promising hepatitis C drug danoprevir to Roche for $175 million in cash and dissolved the collaboration agreement they signed in 2006. In April, InterMune announced encouraging Phase II results from the drug.

Essentially, Adam Feuerstein of TheStreet notes, InterMune is betting the farm on receiving EMA and FDA approval of its idiopathic pulmonary fibrosis treatment Esbriet (pirfenidone). IPF is a rare and fatal lung disease that affects approximately 200,000 people in the U.S. and Europe. Earlier this year, an expert panel voted 9-3 in favor or approving the drug. While not all the panelists were convinced of the drug's efficacy, most though the potential benefits of the drug outweighed their concerns. The FDA, however, didn't see it that way. The agency rejected the drug, requesting a new trial before it would consider approving the treatment. InterMune cut costs, laying off 60 people as it hunkered down for the lean times to come.

With the Roche deal, InterMune says it now expects to have a cash balance of approximately $290 million at the end of 2010. The money will be used to keep the company afloat while it awaits a European decision on the drug. That news is expected in the first quarter of 2011. If European regulators reject the drug, InterMune will be faced with the daunting task of having to launch a new $40 million trial of pirfenidone that could take up to three years to complete.

"After conducting a careful review of our strategy and financial position, we have decided to divest our rights to danoprevir to Roche. This transaction provides a very substantial non-dilutive cash infusion that allows us to continue to independently and aggressively pursue the registration and commercialization of pirfenidone in the US and EU, and eliminates our obligation to make significant ongoing investments related to the further development and commercialization of danoprevir," says InterMune CEO Dan Welch, in a statement. He adds that Roche and InterMune are exploring ways to continue their ongoing work together on other HCV research programs.

- see InterMune's release on the deal
- here's TheStreet article for more

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