InterMune Inc. (ITMN) announced that it received marketing authorization from the European Commission (EC) for its idiopathic pulmonary fibrosis (IPF) drug Esbriet in the European Union (EU), making it the first company to offer an IPF medicine in Europe. The approval of Esbriet in the European Union would give the company a major shot in the arm.
InterMune plans to launch the drug in the top five European countries first, beginning with Germany in September 2011, followed by France, Spain and Italy in the first half of 2012 and in the United Kingdom in mid-2012. It is expected to be launched in almost all the 10 important European nations by mid-2012.
Management provided an update on the Esbriet label. The label provides a broad indication for treatment of mild-to-moderate IPF, with no restriction on the mild-to-moderate qualifier, thus encouraging broad usage. It also includes in addition to the regular safety information, a risk summary of the efficacy results from two phase III trials. The label also stated that liver function tests (LFT) are recommended during the first six months of treatment at monthly intervals, which, we believe, is fairly routine.
Following the approval, InterMune made certain post-approval commitments like conducting a routine safety surveillance of spontaneous adverse drug reactions (ADRs) and a drug-drug interaction study. The company would also implement a risk management plan (RMP) to help ensure the safe use of Esbriet.
Esbriet has been granted orphan drug status in Europe, which provides exclusivity for 10 years leading to loss of protection only in early 2021. Management claims that patents covering formulation and safe use could extend protection till 2030.
Idiopathic pulmonary fibrosis is a fatal lung disease with an estimated survival rate of a meager 20%. Approximately 1,10,000 patients are diagnosed with the disease in the 10 most important European countries, including about 70,000 patients having mild-to-moderate IPF and are thus eligible to take Esbriet.
As regards Esbriet approval in the US, InterMune received a complete response letter (CRL) from the FDA in early May 2010, requesting data from an additional clinical trial before considering the regulatory approval of Esbriet. In January 2011, InterMune announced that it will conduct an additional study (phase III) as requested by the FDA and will meet with the agency later this month to discuss the details of the study. InterMune expects to commence enrollment for the study in June 2011 and provide an update on the US plans in the second quarter following the meeting with the FDA.
Our Recommendation
We currently have a Neutral recommendation on InterMune which is supported by a Zacks #3 Rank (short term hold). We consider the EU approval of Esbriet as well as the impressive product labeling as a major positive for InterMune. However, we prefer to remain Neutral until visibility improves on US approval.
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