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. Esbriet is commercially available in Germany, Austria, Norway, Denmark and Luxembourg.
Since 2008, pirfenidone has been marketed in
as Pirespa® by Shionogi & Co. Ltd.
InterMune is conducting a Phase 3 study, ASCEND, to pursue the registration of Esbriet for the treatment of IPF in
the United States
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, with a five-year survival rate of approximately 20-40 percent, 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
, 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
(ASCEND). Pirfenidone is also approved for the treatment of IPF in
, 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
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 our expectation that IPF patients in
will be reimbursed at a 100% level for drugs with an SMR rating other than "Insufficient", statements related to the anticipated timing of commercial launch for Esbriet® (pirfenidone) in
, statements related to anticipated pricing and reimbursement of Esbriet in
and statements related to our ASCEND trial, including projected timing for completion of enrollment of the trial and expectations for improved probability of the results of such trial based in part on refined enrollment criteria. 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.
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
, 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; (v) risks related to the timing of enrollment of our ASCEND clinical trial, the results of such trial and the prospects for FDA approval of Esbriet in
the United States
; and (vi) 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
Esbriet® is a registered trademark of InterMune, Inc.