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InterMune Still Has Lingering Questions

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Investors were pleased about the data for a new drug but they may be overlooking key questions.

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InterMune (ITMN) claims that it's all set for the meeting of the Pulmonary-Allergy Drugs Advisory Committee scheduled for Tuesday, March 9, but briefing documents released on the FDA website on Friday show that committee members have some questions.

But shareholders aren't taking those questions very seriously.

Shares of the Brisbane, California-based biotech jumped more than 60% in trading on Friday to linger near $24 after documents about its treatment for a fatal lung disease were released by the FDA prior to an expected advisory panel. The stock has been trading between $10.48 and $25.37 over the last 52 weeks. The FDA will likely make a decision on the approval of the drug by May 4; the agency usually follows the recommendation of the committees, but isn't required to.

The drug, pirfenidone, is a treatment for a fatal lung disease that affects about 200,000 people in the US and Europe who are between the ages of 50 and 75. There are currently no drugs on the market available to treat the disease, which causes shortness of breath, coughing, scarring of the lungs, and eventually leads to death.

Due to the lack of treatments available, the FDA fast-tracked InterMune's drug and gave it a Orphan Drug designation -- a status given to certain drugs undergoing development in the pharmaceutical industry.

The data released from two studies last year were of a somewhat mixed bag -- the first trial, 004, showed clear effectiveness of the drug, while the second trial, 006, wasn't quite as clear. Members of the advisory panel questioned whether the reasons the company gave for the lack of clear evidence in trial 006 were substantial and meaningful.

Committee member Banu A. Karimi-Shah, MD said, "When the analysis is conducted without imputation of data for either missing values or death, there is a decrease in the magnitude of the treatment effect size." Karimi-Shah added, "Although several earlier timepoints demonstrated that pirfenidone was statistically better than placebo, the insignificant difference at week 72 calls into question the durability of the efficacy response in trial 006."

Karimi-Shah went on to question the soundness of the secondary endpoints since the primary endpoints weren't met. Karimi-Shah wasn't the only member of the committee to have questions about the drug.

Yet, analysts and shareholders were pleased that the documents weren't quite as negative as they expected them to be.

Leerink Swann analyst Howard Liang called the briefing "relatively benign," but he seemed uncertain which way the committee would go when voting for approval. Liang wrote in a note to investors on Friday:

The FDA also makes it clear that "The Agency usually requires more than one trial to provide independent substantiation of efficacy" and it also notes that the requirements of orphan diseases are no different. The FDA appears to be leaving the decision of relevance of endpoints and "substantial evidence of efficacy" to the committee but it remains to be seen during the committee meeting how strongly the Agency will push the requirement of two positive trials.


Pirfenidone is already approved in Japan and is marketed there by Shinogi under the brand name Pirespa. InterMune also submitted an application for approval in Europe with the European Medicines Agency.

Investors will have to wait until Tuesday to see if the panel will offer further rays of hope for this drug.

No positions in stocks mentioned.

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