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Intermune Up 17% After German Agency Says Esbriet Offers Benefit


Intermune (NASDAQ: ITMN) is up 17% after a German agency said that Esbriet offered medical benefits.

The company today reported that Germany's Federal Joint Committee has announced its decision granting the additional benefit of Esbriet in adults for the treatment of mild-to-moderate idiopathic pulmonary fibrosis. Esbriet's additional benefit was classified as stage 4 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 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."

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