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12:00 AM
Feb 16, 2009
 |  BioCentury  |  Product Development


Although InterMune Inc. is compiling a laundry list of potential reasons why one of its Phase III trials of pirfenidone to treat idiopathic pulmonary fibrosis missed the primary endpoint, the company thinks two other Phase III studies that met their endpoints, combined with the urgent need for treatment, will be enough for approval.

InterMune plans to move forward with NDA and MAA submissions to FDA and EMEA quickly, as Phase III trials of three competing compounds are due to complete or release final data this year.

Investors clearly like the company's chances, driving shares up $6.04 (53%) over the past two weeks to close last week at $17.48. InterMune took advantage of the enthusiasm by pricing a follow-on offering of 3.5 million shares on Friday. Although the price was undisclosed, if sold at Thursday's close of $17.96, the company will have raised $62.9 million. UBS is the sole manager for the offering, which is expected to close Feb. 19.

Pulmonary fibrosis is a lung disorder characterized by progressive scarring and deterioration of the lungs. According to the Coalition for Pulmonary Fibrosis, there are about 128,000 patients in the U.S., with about 48,000 new cases each year. InterMune estimates 30,000 of these are idiopathic pulmonary fibrosis (IPF), for which no known cause can be established.

The five-year survival rate for IPF is about 20% - worse than every cancer except lung cancer - and there are no approved drugs. Patients are treated with prednisone, azathioprine and/or n-acetylcysteine or undergo lung transplant.

InterMune's Actimmune interferon gamma-1b has been used off label for the indication, but the drug's use has declined since 2002, when it failed a Phase III trial. Hoping to confirm results of a post hoc analysis showing improved survival in a subset of patients with mild to moderate disease, the company began the...

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