Healthcare Industry News: pirfenidone
News Release - November 5, 2009
InterMune Announces Appointments of Senior Leadership to Prepare for Potential Launch of PirfenidoneBRISBANE, Calif., Nov. 5 (Healthcare Sales & Marketing Network) -- InterMune, Inc. (Nasdaq: ITMN ) today announced additions to its senior leadership team to prepare for the potential commercialization of pirfenidone in the United States and Europe.
The company announced yesterday that it had submitted a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market pirfenidone for the treatment of IPF. The company expects to submit a Marketing Authorization Application (MAA) to the European Medicines Agency (EMEA) in the first quarter of 2010. pirfenidone has been granted Orphan Drug and Fast Track designation by the FDA, and also has been granted Orphan Drug status in Europe.
Dan Welch, Chairman, Chief Executive Officer and President of InterMune, said, "Today's announcement underscores our commitment to be prepared to bring pirfenidone to patients, should our NDA and/or MAA be granted approval by the regulatory authorities in the United States and Europe, respectively. We are very pleased to have recruited such a high quality team of senior level commercial professionals. Further expansion of our commercial infrastructure will be driven by the outcome of key regulatory events expected in 2010."
US and EU Commercial Leadership Appointments
InterMune announced the following additions to its leadership team:
- Vice President, Sales - Ms. Terri Shoemaker has held senior commercial leadership positions at Du Pont Pharmaceuticals, Bristol-Myers Squibb, Pharmion and Celgene. Most recently at Pharmion (acquired by Celgene), Ms. Shoemaker was responsible for creating the commercial organization and the successful launch of Vidaza®, a chemotherapeutic agent for treating myelodysplastic syndrome and some types of leukemia. She later was promoted to Executive Director, Strategic Commercial Operations at Celgene.
- Vice President, Marketing - Mr. Erik Harris has held senior positions in marketing and sales management at Bristol-Myers Squibb, Genentech and Elan. At Genentech, he held sales and marketing management positions, notably as Group Brand Manager for Rituxan® and Tarceva®. Most recently at Elan, he was a Senior Director of Marketing and Sales in Gastroenterology prior to becoming Senior Director of Strategic Brand Management for Gastroenterology and Neurology. Mr. Harris will assume his responsibilities with InterMune on November 16, 2009.
- Vice President, Managed Care and Access - Mr. Darren Cline has held senior sales, marketing and managed care roles at Schering-Plough, Amgen, InterMune and most recently, Alexion. At Alexion, he served as Executive Director of Sales and played an integral role in the successful launch of Soliris®. While at Amgen, Mr. Cline led a managed care team during the launches of Aranesp® and Neulasta® and was the Reimbursement and Access Marketing Director for Enbrel®.
- These three executives will report to Barrett McGrath, who was announced as InterMune's Vice President of Sales and Marketing on August 6, 2009. With nearly 30 years of experience in the industry, Mr. McGrath has held leadership positions in sales, marketing and business development at Genentech, Du Pont Pharmaceuticals, American Hospital Supply Corporation (now Baxter) and Quintiles Transnational.
- The company also announced today that Mr. Giacomo di Nepi has been appointed to the newly created position of Senior Vice President and General Manager, Europe. Mr. di Nepi held senior roles at the global and country management levels with Novartis. After Novartis, Mr. di Nepi was the EU General Manager for Takeda where he led EU operations and geographic expansion. Prior to Takeda and Novartis, he was a partner at McKinsey & Co., specializing in healthcare. Mr. di Nepi will report to Mr. Welch.
Preclinical and in-vitro evidence had shown that pirfenidone has both anti-fibrotic and anti-inflammatory effects. Results from three adequate and well-controlled Phase 3 studies have shown evidence of a treatment effect in IPF patients and the compound has been safe and generally well tolerated, with side effects including photosensitivity rash and gastrointestinal symptoms.
InterMune licensed pirfenidone from Marnac, Inc. and its co-licensor, KDL GmbH, in 2002 and in 2007 purchased from Marnac and KDL the rights to sell the compound in the United States, Europe and other territories except in Japan, Taiwan and South Korea where rights to the molecule were licensed by Marnac and KDL to Shionogi & Co. Ltd. of Japan. In October of 2008, pirfenidone was approved for use in IPF patients in Japan and is marketed as Pirespa® by Shionogi in that country.
Idiopathic pulmonary fibrosis (IPF) is a disabling and ultimately fatal disease that affects approximately 200,000 patients in the United States and Europe combined, with approximately 30,000 new cases reported per year in each of the United States and Europe.
IPF is characterized by inflammation and scarring (fibrosis) in the lungs, hindering the ability to process oxygen and causing shortness of breath (dyspnea) and cough 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%. 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. There are no medicines approved in the United States or Europe for IPF.
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 pirfenidone for which InterMune has completed a Phase 3 program in patients with IPF (CAPACITY) and has submitted a New Drug Application (NDA) to the FDA. The hepatology portfolio includes the HCV protease inhibitor compound ITMN-191 (RG7227) which entered Phase 2b in August of 2009 and a second-generation HCV protease inhibitor research program. 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 anticipated product development timelines, the interpretation of the CAPACITY clinical data, including certain exploratory analyses conducted by the company with respect to such data and the likelihood of regulatory success. 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. pirfenidone failed to achieve statistical significance on the primary endpoint in one of its two pivotal clinical trials and there can be no assurance that the regulatory authorities in either the United States or Europe will grant regulatory approval based upon these data, in combination with the other efficacy analyses and safety results the company currently intends to submit in support of its NDA and MAA filings. 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 16, 2009 (the "Form 10-K") and other periodic reports filed with the SEC, including the following: (i) risks related to the long, expensive and uncertain clinical development and regulatory process, including having no unexpected safety, toxicology, clinical or other issues or delays in anticipated timing of the regulatory approval process; (ii) risks related to failure to achieve the clinical trial results required to commercialize our product candidates; and (iii) risks related to timely patient enrollment and retention in clinical trials. 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.
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