BERLIN, March 15, 2012 /PRNewswire/ -- InterMune, Inc. (NADSAQ: ITMN) today reported that Germany's Federal Joint Committee (G-BA) has announced its decision granting the additional benefit of Esbriet® (pirfenidone) in adults for the treatment of mild-to-moderate idiopathic pulmonary fibrosis (IPF). Esbriet's additional benefit was classified as stage 4 (not quantifiable benefit) in the rating system established under Germany's AMNOG pharmaceutical law. A non-quantifiable benefit means that the drug has an additional benefit, which will be defined in the future via experience in daily clinical use or clinical studies. Based on this, a stage of 1-3 will be assigned. G-BA is the highest decision-making body of the self-governing healthcare system in Germany.
Today's final assessment of Esbriet's added benefit by the G-BA is improved from the preliminary assessment of the benefits of Esbriet issued by the Institute for Quality and Efficiency in Healthcare (IQWiG) in December 2011. In its preliminary assessment, IQWiG did not determine an additional benefit of Esbriet.
"We are pleased that the G-BA has recognized the additional benefit of Esbriet for patients with IPF," said Dan Welch, Chairman, Chief Executive Officer and President of InterMune. "Esbriet is the first orphan drug to be evaluated under the new German system for assessing the additional benefit to patients of a new medicine. As the only therapy approved for IPF, G-BA determined that there is no appropriate comparator treatment to Esbriet. Today's decision applies to all adult patients with mild-to-moderate IPF and ensures continued reimbursement in Germany for the first drug shown to be efficacious, safe and generally well-tolerated in this relentless and uniformly fatal disease."Dr. Markus Leyck Dieken, InterMune's Senior Vice President and Country Manager for Germany, said, "We appreciate the input of those who helped to inform G-BA in making its decision, including patients, physicians, the pharmaceutical association and the German pulmonology society. We believe their comments were constructive in helping G-BA to arrive at today's final and positive assessment, and we thank them for their contributions on behalf of IPF patients." InterMune's next step is to enter price negotiations with the Statutory Health Insurance, the umbrella organization which represents Germany's sickness funds. Sickness funds are the health insurance providers that reimburse the cost of pharmaceutical products in Germany. Under Germany's AMNOG law, the price charged by a manufacturer for a new pharmaceutical product is reviewed during the 12 months following the medicine's launch. The current price for Esbriet in Germany will remain in effect until the pricing review is completed, which is expected by September 15, 2012. Esbriet ® (pirfenidone) Demonstrates Benefit for Patients In its written and oral comments to G-BA during the review process, InterMune noted that pirfenidone slows both disease progression and the decline of physical performance. Compared to placebo, the results of a pooled analysis of pivotal trials showed that pirfenidone achieved a 31% relative reduction in the decrease in walking distance from the 6-minute walk test (6MWT) (p<0.001). In addition, a pooled analysis showed that pirfenidone significantly reduced the relative decrease in percent predicted forced vital capacity (FVC) by approximately 23%, compared to placebo (p=0.005). Considering the poor prognosis of IPF, the reversible side effects of pirfenidone are viewed as acceptable. Conference Call and Webcast Details InterMune will host a live webcast of a conference call today at 4:00 p.m. EDT to discuss the G-BA's final assessment of Esbriet's additional benefit. 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# 21582928. 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# 21582928.
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