Navigation Links
InterMune to Provide Overview of Corporate Strategy, Update on Esbriet Commercialization Plans in the EU and Details of Phase 3 ASCEND Study
Date:5/25/2011

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 fo
'/>"/>

SOURCE InterMune, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6

Related medicine technology :

1. InterMune Receives European Union Approval for Esbriet® (pirfenidone)
2. InterMune Reports Fourth Quarter and Full Year 2010 Financial Results and Business Highlights
3. InterMune to Present at J.P. Morgan Healthcare Conference
4. InterMune Reports Third Quarter 2010 Financial Results
5. InterMune Announces Four Oral Presentations on Pirfenidone and IPF at the Annual Congress of the European Respiratory Society (ERS)
6. InterMune to Release Second Quarter Financial Results on July 27
7. InterMune Announces Conference Call and Webcast to Discuss Outcome of FDA Advisory Committee
8. FDA Advisory Committee Recommends Approval of InterMunes Esbriet(R) (pirfenidone) for Idiopathic Pulmonary Fibrosis
9. InterMune Announces Posting of Briefing Documents for FDA Advisory Committee Meeting on Pirfenidone
10. InterMune Reports Fourth Quarter and Full Year 2009 Financial Results and Business Highlights
11. InterMune to Participate in Pulmonary-Allergy Drugs Advisory Committee Meeting on March 9, 2010
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:9/2/2014)... , Sept. 2, 2014  Sinovac Biotech Ltd. (NASDAQ: ... in China , today announced that the ... September: , Morgan Stanley Global Healthcare Conference, to ... 9 and 10, 2014. , Morgan Stanley Asia Pacific ... on September 11, 2014. , Aegis Healthcare & Technology ...
(Date:9/2/2014)... , Sept. 2, 2014 /PRNewswire-iReach/ -- WCCT ... recognized as one of the fastest growing companies ... few years, the company has undergone significant growth ... late phase global clinical development, anti-viral and vaccine ... years, WCCT Global has successfully participated in over ...
(Date:9/1/2014)... LONDON , Sept. 1, 2014 /PRNewswire/ ... research report: Rigid Transparent Plastics: ... https://www.reportbuyer.com/product/1941931/Rigid-Transparent-Plastics-Global-Markets-Outside-North-America.html INTRODUCTION ... this report, describing the study goals and ... audience, scope, methodology, information sources and analyst ...
Breaking Medicine Technology:Sinovac to Participate in Upcoming Investor Conferences 2Contract Research Organization WCCT Global Celebrates Being Named as One of the Fastest Growing Companies in America 2Rigid Transparent Plastics: Global Markets Outside North America 2Rigid Transparent Plastics: Global Markets Outside North America 3Rigid Transparent Plastics: Global Markets Outside North America 4Rigid Transparent Plastics: Global Markets Outside North America 5Rigid Transparent Plastics: Global Markets Outside North America 6Rigid Transparent Plastics: Global Markets Outside North America 7Rigid Transparent Plastics: Global Markets Outside North America 8Rigid Transparent Plastics: Global Markets Outside North America 9Rigid Transparent Plastics: Global Markets Outside North America 10Rigid Transparent Plastics: Global Markets Outside North America 11Rigid Transparent Plastics: Global Markets Outside North America 12Rigid Transparent Plastics: Global Markets Outside North America 13Rigid Transparent Plastics: Global Markets Outside North America 14Rigid Transparent Plastics: Global Markets Outside North America 15Rigid Transparent Plastics: Global Markets Outside North America 16Rigid Transparent Plastics: Global Markets Outside North America 17Rigid Transparent Plastics: Global Markets Outside North America 18Rigid Transparent Plastics: Global Markets Outside North America 19Rigid Transparent Plastics: Global Markets Outside North America 20Rigid Transparent Plastics: Global Markets Outside North America 21Rigid Transparent Plastics: Global Markets Outside North America 22Rigid Transparent Plastics: Global Markets Outside North America 23
... ABBOTT PARK, Ill., April 21 Abbott (NYSE: ... strengthening its pharmaceutical pipeline in immunology and oncology. , ... The acquisition provides Abbott with ... that complement its existing diverse oncology program.  The new Abbott compounds ...
... Magellan Biosciences, Inc., an emerging leader in clinical ... first to offer minocycline and telavancin on IVD-labeled microbroth ... (FDA) has cleared TREK-brand Sensititre MIC plates for testing ... as well as telavancin against Gram positive bacterial isolates ...
Cached Medicine Technology:Abbott Completes Acquisition of Facet Biotech 2FDA Clears Three Additional Antimicrobials for Use on TREK Sensititre(R) In Vitro Diagnostic (IVD) MIC Susceptibility Plates: Minocycline and Telavancin Used to Treat MRSA and Other Infections; and Tigecycline, Now Cleared for Streptococcus Pneumoni 2FDA Clears Three Additional Antimicrobials for Use on TREK Sensititre(R) In Vitro Diagnostic (IVD) MIC Susceptibility Plates: Minocycline and Telavancin Used to Treat MRSA and Other Infections; and Tigecycline, Now Cleared for Streptococcus Pneumoni 3FDA Clears Three Additional Antimicrobials for Use on TREK Sensititre(R) In Vitro Diagnostic (IVD) MIC Susceptibility Plates: Minocycline and Telavancin Used to Treat MRSA and Other Infections; and Tigecycline, Now Cleared for Streptococcus Pneumoni 4
(Date:9/2/2014)... Smile Squared, a well-known Buy One, Give One company, ... toothbrush. For every toothbrush purchased, Smile Squared gives one ... created by my wife and me after volunteering at ... of Smile Squared. “There, we saw children who had ... the same children didn't own a toothbrush. We wanted ...
(Date:9/2/2014)... Tuesday 2 September 2014: Health structures explain nearly ... according to the results of a joint ESC-OECD ... Aldo Maggioni. Clinical variables explained more than 80% ... a unique evaluation which combines clinical data and ... a fuller picture of the reasons some patients ...
(Date:9/2/2014)... Aeroflow Healthcare, an industry leader and ... the opening of its new office to be located ... Business Parkway, Suite D, Greer, SC 29651. This new ... a more convenient location in the Greenville area. , ... the physicians, hospitals and patients we serve, to ensure ...
(Date:9/2/2014)... FL (PRWEB) September 02, 2014 ... for about a decade, primarily to help people ... time, there are three developed systems,” says Dana ... approaches substantively differ, the goals are much the ... support of some type of harmonica.” , The ...
(Date:9/2/2014)... During the fall season, before the ... winter months to prevent costly damage later on. Pasquali ... company, suggests these fall preventative home maintenance tips. , ... throughout fall to prevent build up of leaves and ... problems, pest infestations, wet basements, foundation damage and many ...
Breaking Medicine News(10 mins):Health News:Smile Squared's Colorful Buy One, Give One Toothbrush Now Available in Schnucks Stores 2Health News:Health structures explain nearly 20 percent of non-adherence to heart failure guidelines 2Health News:Aeroflow Healthcare Opens Office In Greer, SC To Service Greenville & Spartanburg Patients 2Health News:Harmonica Techs, Inventor of the Pulmonica Pulmonary Harmonica, Outlines New Uses for Harmonicas in Healthcare 2Health News:Harmonica Techs, Inventor of the Pulmonica Pulmonary Harmonica, Outlines New Uses for Harmonicas in Healthcare 3Health News:Northern Virginia Real Estate Company Pasquali Realty Group Suggests These Maintenance Tips for Homeowners This Fall 2
... Largest Increase In Hispanics, Up 18%, New ASPS Plastic ... Tough economic times may have caused ... procedures among ethnic patients are up. According to statistics ... (ASPS), ethnic cosmetic procedures increased 11 percent in 2008, ...
... March 25 An amazing medical discovery that provides ... is in the US and looking to make the ... Release, go to: http://www.prnewswire.com/mnr/bathmateus/37601/ Developed by engineers, originally ... US at www.bathmateus.com , the Bathmate Hydropump reverses ...
... and Accountability Act (HIPAA) consists of a quick glance ... by signing a form stating that we have reviewed ... law that was enacted by Congress to promote health ... protecting the confidentiality, integrity and availability of the information. ...
... heart disease should avoid consuming energy drinks, according to a ... the Annals of Pharmacotherapy . , Researchers found ... a popular energy drink experienced an increase in their blood ... were reported. , The increases in blood pressure and heart ...
... for America,s Health (TFAH) and the Robert Wood Johnson ... America,s Food Safe: A Blueprint for Fixing the Food ... Human Services , which examines problems with the fragmented ... the food safety functions at the U.S. Department of ...
... March 25 Letter Carriers union President William H. Young ... U.S. Postal Service, endangered by the greed and recklessness of ... enacts bipartisan legislation that would save the Postal Service billions ... are not here today to ask for a taxpayer bailout, ...
Cached Medicine News:Health News:Video: Cosmetic Procedures Up In All Ethnic Groups Except Caucasians In 2008 2Health News:Video: Bathmate Hydropump Poised to Replace Cialis, Levitra, and Viagra 2Health News:Conference on safeguarding health information, May 18-19 2Health News:Energy drinks may be harmful to people with hypertension, heart disease 2Health News:New Report Calls Food Safety System Antiquated, Calls for Reform 2Health News:New Report Calls Food Safety System Antiquated, Calls for Reform 3Health News:New Report Calls Food Safety System Antiquated, Calls for Reform 4Health News:Young Tells Congress Survival of Postal Service Could Depend on Passage of Relief Legislation 2
Liquichek Whole Blood Volatiles Control is an assayed liquid control for monitoring volatile compounds. This product is available in 2 levels....
qUAntify Control is designed to monitor the performance of urine dipstick testing. The control is available in 12 mL ready-to-use dropper bottles....
Lyphochek Urine Bone Markers Control is a bilevel human urine based control designed to monitor tests for urinary markers of osteoporosis management and bone resorption....
Lyphochek Tumor Marker Control is a comprehensive, bilevel product designed to assess the performance of various cancer antigen tests, including esoteric tumor markers....
Medicine Products: