InterMune to Provide Overview of Corporate Strategy, Update on Esbriet Commercialization Plans in the EU and Details of Phase 3 ASCEND Study
BRISBANE, Calif., May 25, 2011 /PRNewswire/ -- InterMune (NASDAQ: ITMN) will outline the company's corporate strategy and vision for 2015, including an update on its ongoing plans to commercialize Esbriet® (pirfenidone) in Europe, as well as details on ASCEND, a new Phase 3 pirfenidone study, during a meeting with analysts in New York tomorrow, May 26. InterMune will conduct a live webcast of the presentations beginning at 8:30 a.m. EDT.
Dan Welch, chairman, CEO and president will open the meeting by discussing key elements of the Company's Vision for 2015 and the five Key Success Factors to realize this Vision:
- The timely and successful launch of Esbriet in Europe
- The successful completion of ASCEND and the successful launch of Esbriet in the U.S. in 1H 2014
- The marketing of Esbriet in territories beyond the EU and U.S.
- The successful implementation of an aggressive Esbriet Life Cycle Management Strategy
- The successful implementation of a comprehensive internal and external program to establish an attractive and balanced pipeline
"We have a clear vision of where we expect to be in 2015, and an effective strategy to realize that vision," says Mr. Welch. "We believe our 'Vision 2015' is exciting and realistic and will be realized by successfully executing on the five Key Success Factors that will be detailed tomorrow."
Esbriet in Europe
On February 28, 2011, the European Commission (EC) granted marketing authorization for Esbriet (pirfenidone) in adults for the treatment of mild to moderate IPF, a progressive and fatal lung disease. Esbriet is now authorized for marketing in all 27 EU member states, as well as in Norway and Iceland.
Based on anticipated EU country reimbursement timelines, InterMune currently plans to launch Esbriet as follows: Germany in September of 2011; France, Spain and Italy during the first half of 2012 and the United Kingdom by mid-2012. InterMune plans to have a focused organization in Europe of approximately 125 full-time personnel by the end of 2012, supported by expert consultants and third-party service providers. InterMune will provide an update at the meeting and on the webcast on the company's launch preparations for Esbriet in Europe.
ASCEND: New Phase 3 Trial
During the meeting, Bill Bradford, Senior Vice President of Clinical Science and Biometrics, will provide an update on InterMune's new Phase 3 study named ASCEND (Assessment of Pirfenidone to Confirm Efficacy and Safety in IPF). ASCEND will add to pirfenidone's body of clinical evidence and support a future submission for FDA approval.
ASCEND will be a randomized, 52-week placebo-controlled trial with a primary endpoint of change in forced vital capacity (FVC), a key measure of lung function, between baseline and Week 52. The trial will enroll approximately 500 IPF patients with mild-to-moderate impairment in lung function who will be randomly assigned to receive oral pirfenidone (2403 mg/day) or placebo. More details will be provided at the meeting and on the webcast.
Primary enrollment will take place in the U.S. with additional centers in Mexico, South America, Australia and New Zealand, across more than 140 investigational sites in total. InterMune expects to begin enrollment in ASCEND in June 2011, with all trial participants fully enrolled by the first half of 2012. InterMune anticipates a New Drug Application (NDA) resubmission for pirfenidone in the second half of 2013 and an FDA action in the first half of 2014.
Guidance for 2011 Expenses
InterMune also will discuss at the Analyst Day its 2011 financial guidance for operating expenses. The company today provided its forward-looking expense guidance for 2011 as follows:
- R&D expense: anticipated to be in a range of approximately $85 to $95 million.
- SG&A expense: anticipated to be in a range of approximately $65 to $75 million.
Webcast Information – May 26, 8:30 a.m. EDT
To access the webcast of the Analyst Day presentations, investors and other interested parties may log on to the investor relations page of InterMune's corporate website at 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.
Pirfenidone is an orally active, small molecule drug that 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.
On February 28, 2011, the European Commission (EC) granted marketing authorization for Esbriet® (pirfenidone) for the treatment of adults with 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.
Since 2008, pirfenidone has been marketed in Japan as Pirespa® by Shionogi & Co. Ltd. Pirfenidone is still under investigation for the treatment of IPF in the United States and has not been approved by the U.S. Food and Drug Administration for this use. InterMune currently plans to conduct ASCEND, a new Phase 3 study, toward the goal of bringing pirfenidone to IPF patients in the United States, and currently expects to enroll the first patient in ASCEND in June 2011.
Idiopathic pulmonary fibrosis (IPF) is a progressive, debilitating and ultimately fatal disease that affects approximately 235,000 people in Europe and the United States combined. IPF is characterized by inflammation and scarring (fibrosis) in the lungs, hindering the ability to process oxygen and 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 percent. Patients diagnosed with IPF are usually between the ages of 40 and 70, with a median age of 63 years and 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 hepatology. InterMune has an R&D portfolio addressing idiopathic pulmonary fibrosis (IPF) and hepatitis C virus (HCV) infections. The pulmonology portfolio includes Esbriet® (pirfenidone), which is now approved in the European Union in adults for the treatment of mild to moderate IPF, a progressive and fatal lung disease. The hepatology portfolio includes next-generation HCV protease inhibitor and NS5A research programs. For additional information about InterMune and its R&D pipeline, please visit www.intermune.com.
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 projected operating expenses, commercial launch preparations, anticipated timing of commercial launch and anticipated timing of ASCEND trial enrollment and NDA resubmission for FDA approval. 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 March 9, 2011 (the "Form 10-K"), and other periodic reports filed with the SEC, including but not limited to the following: (i) 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 proposed new 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; 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 www.intermune.com.
Esbriet® is a registered trademark of InterMune, Inc.
SOURCE InterMune, Inc.