Esbriet® (pirfenidone) Benefit Granted by German Federal Joint Committee (G-BA)
Decision applies to all adult patients with mild-to-moderate IPF - InterMune to conduct conference call and webcast at 4:00 PM EDT on 3/15/2012
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.
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. Published epidemiology studies suggest there is a range of between 85,000 and 141,000 IPF patients in Europe, with approximately 113,000 being the median estimate. Patients diagnosed with IPF are primarily between the ages of 40 and 80, with a median age of 63 years. The disease tends to affect slightly more men than women.
InterMune is a biotechnology company focused on the research, development and commercialization of innovative therapies in pulmonology and fibrotic diseases. In pulmonology, InterMune is focused on therapies for the treatment of idiopathic pulmonary fibrosis (IPF), a progressive and fatal lung disease. Pirfenidone, the only medicine approved for IPF anywhere in the world, is approved for marketing by InterMune in the EU as Esbriet® and is currently in a Phase 3 clinical trial in the United States. Pirfenidone is also approved for the treatment of IPF in Japan, where it is marketed by Shionogi & Co. Ltd. under the trade name Pirespa®. InterMune's research programs are focused on the discovery of targeted, small-molecule therapeutics and biomarkers to treat and monitor serious pulmonary and orphan fibrotic diseases. For additional information about InterMune and its R&D pipeline, please visit www.intermune.com.
This news release contains forward-looking statements within the meaning of section 21E of the Securities Exchange Act of 1934, as amended, that reflect InterMune's judgment and involve risks and uncertainties as of the date of this release, including without limitation the statements related to InterMune's expectations of continued reimbursement for Esbriet in Germany, its anticipated next steps of entering into price negotiation with Statutory Health Insurance, its expectations that the current price of Esbriet in Germany will remain in effect until pricing review is complete and the expected timing of the completion of price review for Esbriet in Germany by September 15, 2012. All forward-looking statements and other information included in this press release are based on information available to InterMune as of the date hereof, and InterMune assumes no obligation to update any such forward-looking statements or information. InterMune's actual results could differ materially from those described in InterMune's forward-looking statements.
Other factors that could cause or contribute to such differences include, but are not limited to, those discussed in detail under the heading "Risk Factors" in InterMune's most recent annual report on Form 10-K filed with the Securities and Exchange Commission (SEC) on February 29, 2012 (the "Form 10-K"), and other periodic reports filed with the SEC, including but not limited to the following: (i) risks related to unexpected regulatory actions or delays or government regulation generally; (ii) risks related to the company's manufacturing strategy, which relies on third-party manufacturers and which exposes InterMune to additional risks where it may lose potential revenue; (iii) risks related to government, industry and general public pricing pressures; (iv) risks related to our ability to successfully launch and commercialize Esbriet in the EU, including successfully establishing a commercial operation in the EU and receiving favorable governmental pricing and reimbursement approvals in each EU country; and (v) InterMune's ability to obtain or maintain patent or other proprietary intellectual property protections. The risks and other factors discussed above should be considered only in connection with the fully discussed risks and other factors discussed in detail in the Form 10-K and InterMune's other periodic reports filed with the SEC, all of which are available via InterMune's web site at www.intermune.com.
Esbriet® is a registered trademark of InterMune, Inc.
SOURCE InterMune, Inc.