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.
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
and Iceland. In addition to
, Esbriet® is commercially available in
Since 2008, pirfenidone has been marketed in
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
, 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
, 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 InterMune's expectations of continued reimbursement for Esbriet in
, its anticipated next steps of entering into price negotiation with Statutory Health Insurance, its expectations that the current price of Esbriet in
will remain in effect until pricing review is complete and the expected timing of the completion of price review for Esbriet in
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
Esbriet® is a registered trademark of InterMune, Inc.