InterMune Announces Launch of Esbriet® (pirfenidone) in Germany
Launches in other European countries to follow in 2012
Conference call and webcast scheduled today at 8:30 a.m. EDT
BRISBANE, Calif., Sept. 12, 2011 /PRNewswire/ -- InterMune, Inc. (NASDAQ: ITMN) today announced that Esbriet® (pirfenidone) will be offered to patients in Germany beginning September 15, 2011. This will mark the first time Esbriet will be commercially available in Europe since it was approved by the European Commission in adults for the treatment of mild to moderate idiopathic pulmonary fibrosis (IPF), a devastating and fatal lung disease. Details on the launch of Esbriet in Germanywill be discussed today during a conference call and webcast hosted by InterMune.
"This first launch of Esbriet is an important occasion for patients in Germany and for InterMune," said Dan Welch, Chairman, Chief Executive Officer and President of InterMune. "For the first time, German patients with IPF will have access to a medicine proven to reduce the decline in lung function, offering a treatment where none existed previously. Our team in Germany is well staffed and trained, and fully committed to making Esbriet available to all appropriate patients as rapidly as possible and our entire organization is actively preparing to launch Esbriet throughout Europe beginning in the first half of 2012."
Conference Call and Webcast Details
InterMune will host a conference call and webcast to provide details on the launch of Esbriet in Germany, including, but not limited to information on the size and structure of the German team, the targeting of the sales force, the commercial and medical education strategy for Esbriet and the pricing of Esbriet in Germany. The company will also provide an update on other aspects of its business beyond the German launch.
Investors, analysts and other interested parties may participate in the conference call at 8:30 a.m. EDT today by dialing 888-567-5125 (U.S.) or 706-643-9223 (international), conference ID# 98768414. A replay of the webcast and teleconference will be available on the company's website approximately three hours after the call.
To access the live webcast of the conference call, please log on to the company's website at www.intermune.com at least 15 minutes prior to the start of the call to ensure adequate time for any software downloads that may be required.
A telephonic replay will be available for 10 business days following the call and can be accessed by dialing 855-859-2056 (U.S.) or 404-537-3406 (international), and entering the conference ID# 98768414.
About Esbriet® (pirfenidone)
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 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. It will soon be available in Germany on September 15, 2011 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, Esbriet has been marketed in Japan as Pirespa® by Shionogi & Co. Ltd.
InterMune is currently enrolling patients in a multinational Phase 3 clinical trial of pirfenidone in IPF (ASCEND), the results of which will supplement the existing Phase 3 clinical study data from InterMune's CAPACITY clinical trials to support the potential registration of pirfenidone to treat IPF patients in the United States. At this time pirfenidone is not approved for use in the United States.
Idiopathic pulmonary fibrosis (IPF) is a progressive, debilitating and ultimately fatal disease characterized by inflammation and scarring (fibrosis) in the lungs, hindering the ability to process oxygen. 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.
InterMune is a biotechnology company focused on the research, development and commercialization of innovative therapies in pulmonology and fibrotic diseases. In pulmonology, InterMune is 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 visitwww.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 the commercial launch for Esbriet® (pirfenidone) in Germany and other countries in the EU, and statements regarding timing of the ASCEND trial enrollment. 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.
Esbriet® is a registered trademark of InterMune, Inc.
SOURCE InterMune, Inc.