Here's another peice of exciting news about Pirfenidone just out. It means that if the trials show that the drug is working, the FDA will work to get the approval process underway quickly.
InterMune Announces Receipt of Fast Track Designation for Pirfenidone From FDA
- Conference call scheduled to discuss Shionogi Phase 3 results on pirfenidone -
BRISBANE, Calif., May 19 /PRNewswire-FirstCall/ -- InterMune, Inc. (Nasdaq: ITMN) today announced that its program for the development of pirfenidone for the treatment of idiopathic pulmonary fibrosis (IPF) has received "Fast Track" designation from the U.S. Food and Drug Administration (FDA). Fast Track is a designation that the FDA reserves for a drug intended to treat a serious or life threatening condition and one that demonstrates the potential to address an unmet medical need for the condition. The FDA takes appropriate actions to facilitate the development and expedite the review of the approval applications for fast track products.
Dan Welch, Chairman and Chief Executive Officer of InterMune, said, "There are no approved medicines to treat patients who suffer from IPF, a uniformly fatal disease characterized by scarring and inflammation of the lungs. The FDA's action in granting fast track designation is an indication of pirfenidone's potential to address this serious, unmet medical need. We look forward to reporting top-line results of our Phase 3 CAPACITY program of pirfenidone in IPF, in January of 2009."
Webcast and Conference Call on May 20, 5:00 p.m. EDT
InterMune additionally announced that it will conduct a live webcast and conference call on May 20, 2008 at 5:00 p.m. EDT to discuss its Phase 3 CAPACITY program in the context of data that will be presented by Shionogi & Co., Ltd. regarding its Phase 3 trial of pirfenidone in Japan. The Shionogi Phase 3 results are scheduled to be reported in an oral presentation at the meeting of the American Thoracic Society in Toronto at 2:15 p.m. EDT on May 20.
Interested investors and others may participate in the InterMune conference call by dialing 888-799-0528 (U.S.) or 706-634-0154 (international), conference ID# 48122233. A replay of the webcast and teleconference will be available approximately three hours after the call.
The teleconference replay will be available for 10 business days following the call and can be accessed by dialing 800-642-1687 (U.S.) or 706-645-9291 (international), and entering the conference ID# 48122233.
To access a live audio webcast of the conference call, investors and other interested parties may log on to the investor relations page of InterMune's corporate website at http://www.intermune.com. The company recommends logging on to the site 15 minutes prior to the start of the presentation in order to register or download any necessary software.
About InterMune
InterMune is a biotechnology company focused on the research, development and commercialization of innovative therapies in pulmonology and hepatology. InterMune has a research and development portfolio addressing idiopathic pulmonary fibrosis (IPF) and hepatitis C virus (HCV) infections. The pulmonology portfolio includes the Phase 3 program, CAPACITY, which is evaluating pirfenidone for the treatment of patients with IPF and a research program focused on small molecules for pulmonary disease. The hepatology portfolio includes the HCV protease inhibitor compound ITMN-191 (referred to as R7227 at Roche) in Phase 1b, a second-generation HCV protease inhibitor research program, and a research program evaluating a new target in hepatology. For additional information about InterMune and its R&D pipeline, please visit http://www.intermune.com/.
Forward-Looking Statements
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 anticipated future financial results and product development. 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 SEC on March 14, 2008 (the "Form 10-K") and other periodic reports filed with the SEC, including the following: (i) risks related to the uncertain, lengthy and expensive clinical development and regulatory process, including having no unexpected safety, toxicology, clinical or other issues; (ii) risks related to achieving positive clinical trial results; (iii) the results of the InterMune CAPACITY trials of pirfenidone may differ materially from those of the Shionogi & Co., Ltd. Phase 3 trial of pirfenidone in Japan; (iv) the designation of pirfenidone for Fast Track status by the FDA does not guarantee that the FDA will grant Priority Review of the NDA filed by InterMune in connection with the approval of pirfenidone for the treatment of IPF in the United States. 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 http://www.intermune.com.
SOURCE InterMune, Inc. - 05/19/2008
InterMune Announces Receipt of Fast Track Designation for Pirfenidone From FDA
- Conference call scheduled to discuss Shionogi Phase 3 results on pirfenidone -
BRISBANE, Calif., May 19 /PRNewswire-FirstCall/ -- InterMune, Inc. (Nasdaq: ITMN) today announced that its program for the development of pirfenidone for the treatment of idiopathic pulmonary fibrosis (IPF) has received "Fast Track" designation from the U.S. Food and Drug Administration (FDA). Fast Track is a designation that the FDA reserves for a drug intended to treat a serious or life threatening condition and one that demonstrates the potential to address an unmet medical need for the condition. The FDA takes appropriate actions to facilitate the development and expedite the review of the approval applications for fast track products.
Dan Welch, Chairman and Chief Executive Officer of InterMune, said, "There are no approved medicines to treat patients who suffer from IPF, a uniformly fatal disease characterized by scarring and inflammation of the lungs. The FDA's action in granting fast track designation is an indication of pirfenidone's potential to address this serious, unmet medical need. We look forward to reporting top-line results of our Phase 3 CAPACITY program of pirfenidone in IPF, in January of 2009."
Webcast and Conference Call on May 20, 5:00 p.m. EDT
InterMune additionally announced that it will conduct a live webcast and conference call on May 20, 2008 at 5:00 p.m. EDT to discuss its Phase 3 CAPACITY program in the context of data that will be presented by Shionogi & Co., Ltd. regarding its Phase 3 trial of pirfenidone in Japan. The Shionogi Phase 3 results are scheduled to be reported in an oral presentation at the meeting of the American Thoracic Society in Toronto at 2:15 p.m. EDT on May 20.
Interested investors and others may participate in the InterMune conference call by dialing 888-799-0528 (U.S.) or 706-634-0154 (international), conference ID# 48122233. A replay of the webcast and teleconference will be available approximately three hours after the call.
The teleconference replay will be available for 10 business days following the call and can be accessed by dialing 800-642-1687 (U.S.) or 706-645-9291 (international), and entering the conference ID# 48122233.
To access a live audio webcast of the conference call, investors and other interested parties may log on to the investor relations page of InterMune's corporate website at http://www.intermune.com. The company recommends logging on to the site 15 minutes prior to the start of the presentation in order to register or download any necessary software.
About InterMune
InterMune is a biotechnology company focused on the research, development and commercialization of innovative therapies in pulmonology and hepatology. InterMune has a research and development portfolio addressing idiopathic pulmonary fibrosis (IPF) and hepatitis C virus (HCV) infections. The pulmonology portfolio includes the Phase 3 program, CAPACITY, which is evaluating pirfenidone for the treatment of patients with IPF and a research program focused on small molecules for pulmonary disease. The hepatology portfolio includes the HCV protease inhibitor compound ITMN-191 (referred to as R7227 at Roche) in Phase 1b, a second-generation HCV protease inhibitor research program, and a research program evaluating a new target in hepatology. For additional information about InterMune and its R&D pipeline, please visit http://www.intermune.com/.
Forward-Looking Statements
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 anticipated future financial results and product development. 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 SEC on March 14, 2008 (the "Form 10-K") and other periodic reports filed with the SEC, including the following: (i) risks related to the uncertain, lengthy and expensive clinical development and regulatory process, including having no unexpected safety, toxicology, clinical or other issues; (ii) risks related to achieving positive clinical trial results; (iii) the results of the InterMune CAPACITY trials of pirfenidone may differ materially from those of the Shionogi & Co., Ltd. Phase 3 trial of pirfenidone in Japan; (iv) the designation of pirfenidone for Fast Track status by the FDA does not guarantee that the FDA will grant Priority Review of the NDA filed by InterMune in connection with the approval of pirfenidone for the treatment of IPF in the United States. 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 http://www.intermune.com.
SOURCE InterMune, Inc. - 05/19/2008
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