Health Canada Approves Esbriet® as First Treatment for Fatal Lung Disease
- Novel oral therapy slows progression of IPF in mild to moderate patients -
- Esbriet expected to be available on January 1, 2013 -
- Company to provide more details on third quarter earnings call -
BRISBANE, Calif., Oct. 2, 2012 /PRNewswire/ -- InterMune, Inc. (NASDAQ: ITMN) today announced that Health Canada has approved Esbriet® (pirfenidone) for the treatment of mild to moderate idiopathic pulmonary fibrosis (IPF) in adult patients. IPF is a progressive and uniformly fatal disease that affects approximately 5,000 to 8,000 Canadians, is characterized by scarring of lung tissue, and has a similar short life expectancy to that of many forms of cancer, including lung, colorectal and breast cancers. Health Canada designated Esbriet for Priority Review and completed the accelerated review according to target guidelines of 180 days.
"After over a decade of failed clinical trials of multiple innovative drugs for IPF, today's announcement of Health Canada's approval of Esbriet is an exciting one for IPF patients and the larger IPF community," said Charles Chan, M.D., an IPF researcher and Consultant Respirologist at University Health Network, Professor and Vice-Chair of Medicine, University of Toronto. "I am very pleased to finally have a treatment option with proven benefit for patients with this challenging disease."
Pirfenidone is the first and only medicine approved anywhere in the world for the treatment of IPF. In addition to Canada, pirfenidone is approved in 29 European countries under the InterMune trade name Esbriet and in Japan and South Korea where it is marketed by Shionogi & Co. Ltd under the trade name Pirespa®. Under different trade names, pirfenidone is also approved for the treatment of IPF in China, India, and Argentina. InterMune is conducting an additional Phase 3 study, ASCEND, to support the regulatory registration of Esbriet for the treatment of IPF in the United States.
"With the approval of Esbriet by Health Canada we are very pleased to have made another big step toward our objective to bring Esbriet to as many IPF patients as possible – and as soon as possible," said Daniel Welch, Chairman, Chief Executive Officer and President of InterMune.
While Health Canada has now approved Esbriet for the treatment of mild to moderate IPF in adult patients, it is not yet available for sale in Canada. InterMune expects that Esbriet will be available on January 1, 2013. The company is currently working to secure reimbursement of Esbriet from private insurance providers and the public (provincial) drug reimbursement plans in Canada. Approximately one-third of IPF patients in Canada are covered by private insurance and InterMune expects to secure private insurance coverage from some private insurance plans in the first quarter of 2013 and from substantially all of the private insurance plans in the second quarter of 2013. Public (provincial) drug reimbursement plans cover approximately two-thirds of IPF patients in Canada and reimbursement of new medicines from these plans is typically secured within six to 18 months of launch.
Preclinical and in-vitro evidence suggests that Esbriet has both anti-fibrotic and anti-inflammatory effects. In its clinical development program, Esbriet was demonstrated to be effective in decreasing decline in lung function, slowing the progression of the disease and preserving exercise tolerance.
Esbriet was also safe and generally well-tolerated with the most frequent side effects reported being rash and gastrointestinal symptoms. The safety and tolerability of Esbriet in IPF patients is well-characterized based on both clinical studies and the expanding post marketing experience. Safety results from ongoing studies of Esbriet demonstrated that long-term treatment with Esbriet for up to 7.7 years was safe and generally well-tolerated, with a long-term safety profile similar to that observed in Esbriet's original clinical study program.
About Esbriet® (pirfenidone)
Esbriet 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, or scarring, of the lung. It also inhibits the synthesis of TNF-alpha, a cytokine that is known to have an active role in inflammation.
Esbriet 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, or scarring, of the lung. 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 granted marketing authorization for Esbriet in adults for the treatment of mild to moderate IPF. The approval authorized marketing of Esbriet in all 27 EU member states. Esbriet has since also been approved for marketing in Norway and Iceland -- and now, Canada. Esbriet is now commercially available in Austria, Denmark, Germany, Iceland, Luxembourg, Norway and Sweden, and is expected to be made available in France by the end of 2012.
About IPF
Idiopathic pulmonary fibrosis (IPF) is a progressive, debilitating and ultimately fatal disease characterized predominantly by fibrosis (scarring) in the lungs that compromises lung function and hinders gas exchange. Approximately 5,000 to 8,000 patients are estimated to be living with IPF across Canada, of whom 3,500 to 5,000 are estimated to have mild to moderate disease. IPF is a progressive disease, meaning that over time, lung scarring, symptoms, and functional limitations 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 ovarian, colorectal, and breast. 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.
Idiopathic pulmonary fibrosis (IPF) is a progressive, debilitating and ultimately fatal disease characterized predominantly by fibrosis (scarring) in the lungs that compromises lung function and hinders gas exchange. Approximately 5,000 to 8,000 patients are estimated to be living with IPF across Canada, of whom 3,500 to 5,000 are estimated to have mild to moderate disease. IPF is a progressive disease, meaning that over time, lung scarring, symptoms, and functional limitations 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 ovarian, colorectal, and breast. 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 orphan fibrotic diseases. In pulmonology, the company is focused on therapies for the treatment of idiopathic pulmonary fibrosis (IPF), a progressive and fatal lung disease. Pirfenidone, the only medicine approved for IPF anywhere in the world, is approved for marketing by InterMune in 29 European countries and Canada as Esbriet and is currently in an additional Phase 3 clinical trial to support regulatory registration in the United States. Additional information about the study is available at www.ASCENDtrial.com. For additional information about InterMune and its R&D pipeline, please visit www.intermune.com.
InterMune is a biotechnology company focused on the research, development and commercialization of innovative therapies in pulmonology and orphan fibrotic diseases. In pulmonology, the company is focused on therapies for the treatment of idiopathic pulmonary fibrosis (IPF), a progressive and fatal lung disease. Pirfenidone, the only medicine approved for IPF anywhere in the world, is approved for marketing by InterMune in 29 European countries and Canada as Esbriet and is currently in an additional Phase 3 clinical trial to support regulatory registration in the United States. Additional information about the study is available at www.ASCENDtrial.com. For additional information about InterMune and its R&D pipeline, please visit 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 the estimated size of the patient population in Canada suffering from IPF; the number of patients in Canada covered by private insurance and public drug reimbursement plans; InterMune's expectation and the projected timing for making Esbriet available in Canada in January 2013 and in France by the end of 2012, securing private insurance coverage for Esbriet, and securing reimbursement of new medicines from public drug reimbursement plans; the role of Esbriet in the treatment of patients with IPF and InterMune's expectation regarding the timing and nature of full enrollment in the ASCEND study and the prospects of success thereof to support regulatory registration of Esbriet for the treatment of IPF in the United States. 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 February 29, 2012 (the "Form 10-K"), most recent quarterly report on Form 10-Q filed with the SEC on August 8, 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 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 unexpected regulatory actions or delays or government regulation generally; (iv) risks related to the company's manufacturing strategy, which relies on third-party manufacturers; (v) risks related to our ability to successfully launch and commercialize Esbriet; 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, Form 10-Q and InterMune's other periodic reports filed with the SEC, all of which are available via InterMune's web site at 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 the estimated size of the patient population in Canada suffering from IPF; the number of patients in Canada covered by private insurance and public drug reimbursement plans; InterMune's expectation and the projected timing for making Esbriet available in Canada in January 2013 and in France by the end of 2012, securing private insurance coverage for Esbriet, and securing reimbursement of new medicines from public drug reimbursement plans; the role of Esbriet in the treatment of patients with IPF and InterMune's expectation regarding the timing and nature of full enrollment in the ASCEND study and the prospects of success thereof to support regulatory registration of Esbriet for the treatment of IPF in the United States. 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 February 29, 2012 (the "Form 10-K"), most recent quarterly report on Form 10-Q filed with the SEC on August 8, 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 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 unexpected regulatory actions or delays or government regulation generally; (iv) risks related to the company's manufacturing strategy, which relies on third-party manufacturers; (v) risks related to our ability to successfully launch and commercialize Esbriet; 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, Form 10-Q 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.
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