Germany's Federal Joint Committee (G-BA) has decided to grant the additional benefit of InterMune Inc.'s, 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.

This 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, CEO 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.

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 per cent, compared to placebo (p=0.005). Considering the poor prognosis of IPF, the reversible side effects of pirfenidone are viewed as acceptable.

Esbriet (pirfenidone) is an orally active drug, indicated in adults for the treatment of mild-to-moderate idiopathic pulmonary fibrosis (IPF). The anti-fibrotic acting pirfenidone inhibits the synthesis of TGF-beta, a chemical mediator that controls many cell functions including proliferation and differentiation, and plays a key role in fibrosis. It also inhibits the synthesis of TNF-alpha, a cytokine that is known to have an active role in inflammation.

On February 28, 2011, the European Commission (EC) granted marketing authorization for Esbriet in adults for the treatment of mild to moderate IPF.  The approval authorizes marketing of Esbriet in all 27 EU member states.  Esbriet has since been approved for marketing in Norway and Iceland. In addition to Germany, Esbriet is commercially available in Austria, Norway, Denmark and Luxembourg.

Since 2008, pirfenidone has been marketed in Japan as Pirespa by Shionogi & Co. Ltd. In the United States, pirfenidone is currently being evaluated for the treatment of IPF in another clinical trial and is not yet approved by the FDA for this indication.

Idiopathic Pulmonary Fibrosis (IPF) is a progressive, debilitating and ultimately fatal disease characterized predominantly by fibrosis (scarring) in the lungs, hindering the ability for gas exchange in the lungs. IPF is a progressive disease, meaning that over time, lung scarring and symptoms increase in severity. The median survival time from diagnosis is two to five years, which makes IPF more rapidly lethal than many cancers, including breast, ovarian and colorectal.

InterMune is a biotechnology company focused on the research, development and commercialization of innovative therapies in pulmonology and fibrotic diseases.