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Quotes & Info
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| ITMN > SEC Filings for ITMN > Form 8-K on 29-Nov-2012 | All Recent SEC Filings |
29-Nov-2012
Other Events
On November 29, 2012, the National Institute for Health and Clinical Excellence
(NICE), a special health authority of the English National Health Service (NHS)
responsible for providing guidance to the NHS in England and Wales on what
represents the standards of care that local providers are expected to deliver,
issued its provisional recommendations on the use of Esbriet ® (pirfenidone) for
the treatment of Idiopathic Pulmonary Fibrosis (IPF). NICE's provisional
recommendation is not to recommend pirfenidone for use on the NHS in England and
Wales. This provisional recommendation is consistent with InterMune's previously
announced expectations described in its third quarter 2012 earnings call on
November 7, 2012 regarding the likely outcome of the NICE provisional
recommendation concerning the use of Esbriet for the treatment of IPF.
This recommendation is not NICE's final guidance on pirfenidone, and the recommendation is only provisional at this stage and may change after further consultation. A second committee meeting will be held on January 29, 2013 where a second round of draft guidance may be published ahead of final guidance from NICE. InterMune expects this second assessment process to be completed in March 2013.
This Report 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 expectation regarding its potential success in receiving a positive recommendation from NICE with regard to the use of pirfenidone to treat IPF and the second round of draft guidance from NICE, including the timing of the second assessment process. All forward-looking statements and other information included in this Report 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 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
unexpected regulatory actions or delays or government regulation generally; and
(iii) risks related to our ability to successfully commercialize Esbriet in the
EU. 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.
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