InterMune is a biotechnology company focused on the research, development and commercialization of innovative therapies in pulmonology and orphan fibrotic diseases. In pulmonology, the Company 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 and
as Esbriet® and is currently in a Phase 3 clinical trial to support regulatory approval in the United States. InterMune's research programs are focused on the discovery of targeted, small-molecule therapeutics and biomarkers to treat and monitor serious pulmonary and fibrotic diseases. For additional information about InterMune, 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 regarding InterMune's expectations that Esbriet will show consistent growth and become a very meaningful brand in
in the coming years; its anticipated full-year 2012 operating expenses; its anticipated timing of concluding pricing and reimbursement discussions and/or initiating commercial launches for Esbriet in various European countries; its expectations regarding the size of its European commercial infrastructure; InterMune's expectations regarding the timing of building its U.S. commercial infrastructure and preparations for a pre-launch of Esbriet in the U.S.; InterMune's projected revenue from sales of Esbriet and operating expenses for 2013; and its expectation regarding the timing and nature of enrollment in, and results of, the ASCEND study and the prospects of success thereof. 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"), most recent quarterly report on Form 10-Q filed with the SEC on
November 9, 2012
(the "Form 10-Q") and other periodic reports filed with the SEC, including but not limited to the following: (i) the risks related to the uncertain, lengthy and expensive clinical development process for the Company's product candidates, including having no unexpected safety, toxicology, clinical or other issues and having no unexpected clinical trial results such as unexpected new clinical data and unexpected additional analysis of existing clinical data; (ii) risks related to the regulatory process for the Company's product candidates, including the possibility that the results of the 52-week Phase 3 clinical trial (ASCEND) having an FVC endpoint may not be satisfactory to the FDA for InterMune to receive regulatory approval for pirfenidone in
the United States
; (iii) risks related to unexpected regulatory actions or delays or government regulation generally; (iv) 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; (v) government, industry and general public pricing pressures; (vi) risks related to our ability to successfully launch and commercialize Esbriet in the EU and
, including successfully establishing a commercial operation in the EU and
and receiving favorable governmental pricing and reimbursement approvals in each EU country and securing coverage from private insurance plans and reimbursement from public (provincial) drug reimbursement plans in
; and (vii) 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, Form 10-Q and InterMune's other periodic reports filed with the SEC, all of which are available via InterMune's web site at
SOURCE InterMune, Inc.