New Data Demonstrate Longer-Term Safety Profile of Esbriet®

AMSTERDAM, Sept. 26, 2011 /PRNewswire/ -- InterMune, Inc. (NASDAQ:ITMN) today reported that new data(1) was presented at the European Respiratory Society (ERS) Annual Congress supporting the longer-term safety and tolerability of Esbriet^® (pirfenidone) in patients with idiopathic pulmonary fibrosis (IPF), a devastating lung disease.  Approximately 30,000-35,000 new IPF patients are diagnosed in Europe each year, with an estimated median survival of only two to five years. The announcement follows the recent marketing authorization of Esbriet in Europe and its first launch in Germany on 15 September.

Professor Ulrich Costabel, from the Department of Pneumology/Allergy at the Ruhrlandklinik, University of Duisburg-Essen, Essen, Germany who presented the data, said: "These new data from the RECAP study show that the safety profile of pirfenidone remains consistent, even when pirfenidone treatment continued beyond three years, thereby adding to the growing body of evidence that supports the treatment of IPF with pirfenidone. This news should be welcomed by European clinicians who will soon have the opportunity to treat their mild to moderate IPF patients with this new medicine."

The RECAP extension study data, presented on 25 September at ERS, highlighted the positive longer-term safety and tolerability of Esbriet in patients with IPF. RECAP is an open-label extension study for patients who participated in the Phase 3 program for Esbriet, known as CAPACITY.  The CAPACITY program (studies 004 and 006) was designed to evaluate the treatment effect of Esbriet in IPF patients. In the CAPACITY studies, 779 patients were randomized to treatment with Esbriet or placebo and 626 patients completed the study. Of these, 603 (96 percent) were enrolled in RECAP.  

"IPF is a devastating condition with no proven management options other than lung transplantation, so we hope that this new longer-term safety data will reinforce the known safety and importance of Esbriet as the future standard of care for patients living with IPF," said Giacomo Di Nepi, InterMune's Senior Vice President and Managing Director, Europe.  "Germany is the first country in Europe where Esbriet is now available to patients, and we are glad to be able to offer now this new treatment opportunity to patients with mild to moderate IPF."

RECAP Study Results

At Week 72 in RECAP, mean exposure to pirfenidone 2403 mg/d across both studies was 2.9 years (range, 1-4); 114 patients had received Esbriet 2403 mg/d for at least three years.  The favorable safety and tolerability profile observed in CAPACITY and other prior clinical trials was confirmed in RECAP.

In RECAP, treatment-emergent adverse events (TEAE) and common adverse events (AEs) were very similar to those reported in CAPACITY:

• 98 percent of RECAP patients reported at least one TEAE compared to 99 percent in the treatment arm and 98 percent in the placebo arm of the CAPACITY program.
• In RECAP, 33 percent of patients had a serious TEAE compared to 33 percent in the treatment arm and 31 percent in the placebo arm during CAPACITY.
• The incidence of common AEs in RECAP was very similar to that observed in CAPACITY and these AEs were generally mild to moderate in severity.  The type and frequency of adverse events were generally consistent with observations from the Phase 3 clinical trials; no new safety signals or trends were observed.
• The overall incidence of photosensitivity or rash was lower in RECAP than in CAPACITY (20 percent of patients vs. 44 percent). Rash and photosensitivity reactions were more common among patients newly initiating treatment with pirfenidone compared with those who were continuing treatment (28 percent vs. 12 percent); however, the incidence was similar to that observed among pirfenidone-treated patients in the CAPACITY studies.

About CAPACITY

The CAPACITY program was comprised of two multinational, double-blind, placebo-controlled Phase 3 studies (Study 004 and Study 006) that were conducted simultaneously with 779 IPF patients (aged 40-80 years) across 110 centers in Australia, Europe and North America. Patients were randomly assigned to receive oral Esbriet (1197 or 2403 mg/day) or placebo for a minimum of 72 weeks to evaluate the impact of Esbriet in reducing lung function deterioration in IPF patients.

CAPACITY results demonstrated that treatment with Esbriet:

• Positively impacted key measures of lung function in IPF patients, including a significant reduction in the decline of Forced Vital Capacity (FVC).
• Led to a significant reduction in the decline of Six-Minute Walk Test (6MWT) distance, an indication of improved pulmonary function.
• In addition, an independent meta-analysis of progression free survival suggested a 30 percent lower risk of death or disease progression.(2)

About Esbriet

Esbriet (pirfenidone) is an orally active 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 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 Norway and Iceland. It is now available in Germany and is scheduled to be available in France, Italy and Spain during the first half of 2012 and in the United Kingdom during the third quarter of 2012.

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.

About IPF

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, with a five-year survival rate of approximately 20-40 percent, which makes IPF more rapidly lethal than many cancers, including breast, ovarian and colorectal. An estimated 30,000-35,000 new cases of IPF are diagnosed in Europe each year. 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.

About InterMune

InterMune is a biotechnology company focused on the research, development and commercialization of innovative therapies in pulmonology and fibrotic diseases. In pulmonology, we are focused on therapies for the treatment of idiopathic pulmonary fibrosis (IPF), a progressive and fatal lung disease. Pirfenidone, the only medicine approved worldwide for IPF, 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 Japan, 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 fibrotic diseases. For additional information about InterMune, please visit www.intermune.com.

Esbriet^® is a registered trademark of InterMune, Inc.

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 the commercial launches of Esbriet® (pirfenidone) in the EU.  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) (the "Form 10-K"), and other periodic reports filed with the SEC, including but not limited to the following: (i) 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; (ii) risks related to the regulatory process for the company's product candidates, including the possibility that the results of the 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 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; (iv) risks related to unexpected regulatory actions or delays or government regulation generally; (v) risks related to the company's manufacturing and product distribution strategy, which relies on third-parties and which exposes InterMune to additional risks where it may lose potential revenue; (vi) government, industry and general public pricing pressures; 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 and InterMune's other periodic reports filed with the SEC, all of which are available via InterMune's web site at www.intermune.com.    

(1) Costabel U, Albera C, Cohen A, Bradford WZ, King TE Jr, Noble PW, Sahn SA, Valeyre D, du Bois RM: The long-term safety of pirfenidone in patients with idiopathic pulmonary fibrosis (IPF): Interim data from the RECAP extension study. European Respiratory Society Annual Congress; Abstract number 855888: Presented at 09:00 on Sunday 25 September 2011.

(2) Spagnolo P, Del Giovane C, Luppi F, Cerri S, Balduzzi S, Walters EH, D'Amico R, Richeldi L: Non-steroid agents for idiopathic pulmonary fibrosis (Review). The Cochrane Library 2010, Issue 9.

SOURCE InterMune, Inc.