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France's Transparency Commission (CT) Issues Favorable Opinion For Reimbursement Of Esbriet® (pirfenidone)

Stocks in this article: ITMN

ASMR I:          Major therapeutic advance

ASMR II:         Important improvement as far as effectiveness and/or reduction of side effects are concerned

ASMR III:        Moderate improvement as far as effectiveness and/or reduction of side effects are concerned

ASMR IV:       Minor improvement as far as effectiveness and/or clinical or pharmacokinetics usefulness are concerned

ASMR V:        Absence of improvement but favorable opinion for registration on the reimbursed drugs list

Since the beginning of 2011, with its significantly more challenging reimbursement process, benefit ratings of new medicines have trended significantly lower.  Based on information published on the HAS website, since early 2011 the CT has granted an ASMR rating of IV in 23% of applications.  A rating of V (absence of improvement) was granted in 33%, no ASMR rating was given (due to an SMR of "Insufficient") in about 32% of applications, and only 11% of applications were granted an ASMR rating higher than IV (I, II or III).

About ALD

In France, diseases requiring a long-term, expensive treatment are defined as ALD (Affection de Longue Duree – Long Term Diseases) and patients are fully reimbursed by the National Social Security for all the costs related to this disease (hospitalizations, lab tests, medicines, etc.).  More than 8 million French citizens are reimbursed under this scheme.  There are 30 broad disease categories – including cancer, several cardiovascular diseases and others – as well as smaller diseases grouped in a separate category.  Most orphan diseases fall into this scheme.

Conference Call and Webcast Details

InterMune will host a live webcast of a conference call today at 4:30 p.m. EDT to discuss the CT's assessment of Esbriet in France, and the ASCEND Phase 3 clinical trial of Esbriet in IPF patients in the United States and other territories.  Interested investors and others may participate in the conference call by dialing 800-891-8257 (U.S.) or +1-212-271-4651 (international), conference ID# 21587875.  A replay of the webcast and teleconference will be available approximately three hours after the call.

To access the webcast, please log on to the company's website at www.intermune.com at least 15 minutes prior to the start of the call to ensure adequate time for any software downloads that may be required.

A telephonic replay will be available for 10 business days following the call and can be accessed by dialing 800-633-8284 (U.S.) or +1 402-977-9140 (international), and entering the conference ID# 21587875.

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