Navigation Links
Boehringer Ingelheim to Announce Pivotal Phase 3 Hepatitis C Data at the International Liver Congress

RIDGEFIELD, Conn., April 8, 2013 /PRNewswire/ -- Boehringer Ingelheim today announced that data from its pivotal STARTVerso™ 1 Phase 3 hepatitis C clinical trial have been accepted for oral presentation as a late-breaker at the International Liver Congress™ 2013: 48th Annual Meeting of the European Association for the Study of the Liver (EASL), taking place from April 24-28 in Amsterdam, The Netherlands.

The STARTVerso™ 1 trial evaluated faldaprevir (BI 201335), an investigational oral protease inhibitor specifically designed to target and inhibit viral replication in the liver, in combination with pegylated interferon and ribavirin (PegIFN/RBV). The study was conducted in treatment-naïve patients with genotype-1 infection, the most common and one of the most challenging types of hepatitis C to cure.

Further sub-analyses from Boehringer Ingelheim's interferon-free Phase 2b SOUND-C2 study will also be presented at the Congress. The SOUND-C2 trial evaluated the interferon-free combination of faldaprevir and BI 207127, an investigational non-nucleoside NS5B polymerase inhibitor, plus ribavirin.

Boehringer Ingelheim is developing faldaprevir as a core component of both interferon-based and interferon-free hepatitis C treatment regimens. Through robust science, Boehringer Ingelheim's goal is to find answers to the ongoing challenges faced by a diverse population of patients with hepatitis C.

The STARTVerso™ 1 abstract can be accessed through the Congress website beginning on April 23 and the SOUND-C2 abstracts can be accessed today. Oral PresentationStudyLead AuthorPresentation DetailsSTARTVerso™ 1

P. Ferenci

Embargoed until April 23 at 12:00PM CET (6:00AM ET)Poster PresentationsTitleLead Author Presentation Details An analysis of response rates 

by fibrosis stage in patients

treated with faldaprevir,

BI 207127 and ribavirin in the SOUND-C2 study

S. ZeuzemAbstract number 1227

Date: Sat. April 27
Time: 9:00 AM – 6:00 PM CET (3:00 AM – 12:00 PM ET)

Poster Session: P03-08d, Category 08d: Viral Hepatitis C: Clinical (new compounds, resistance) ITPA gene variants predict

haemolytic ribavirin induced

anaemia in patients treated

with the interferon-free
regimen of faldaprevir,
BI 207127 and ribavirin in 

T. AsselahAbstract number 1186

Date: Sat. April 27
Time: 9:00 AM – 6:00 PM CET (3:00 AM – 12:00 PM ET)

Poster Session: P03-08d, Category 08d: Viral Hepatitis C: Clinical (new compounds, resistance) The relationship between
sustained virological response
and plasma concentrations of
faldaprevir or BI 207127 in HCV 
GT1-infected patients in

S. OlsonAbstract number 1212

Date: Sat. April 27
Time: 9:00 AM – 6:00 PM CET (3:00 AM – 12:00 PM ET)

Poster Session: P03-08d, Category 08d: Viral Hepatitis C: Clinical (new compounds, resistance) About Boehringer Ingelheim in Hepatitis C Virus (HCV)In partnership with the scientific community, our clinical trial program is rigorously designed to find answers to the challenges that HCV patients face, including those who are the most difficult to treat. Our pivotal HCV clinical trials for faldaprevir and BI 207127 are comprised of two multi-trial programs, STARTVerso™ and HCVerso™.

Faldaprevir, also known as BI 201335, is an investigational, oral protease inhibitor that is specifically designed to target viral replication in the liver. STARTVerso™ 1 is the first of an ongoing multi-study Phase 3 trial program that is evaluating faldaprevir combined with PegIFN/RBV. Three additional STARTVerso™ trials in treatment-naïve, treatment-experienced and HIV co-infected patients with chronic genotype-1 HCV are near clinical completion. BI 207127 is an investigational NS5B non-nucleoside polymerase inhibitor that has shown the potential to eliminate interferon from HCV treatment when combined in a regimen with faldaprevir and RBV. Phase 2 trials of this interferon-free regimen have been completed and Phase 3 HCVerso™ trials are now underway. As part of our long-term commitment to HCV, the company is exploring other combinations of investigational HCV compounds that work in different ways. The recent collaboration of Boehringer Ingelheim with Presidio Pharmaceuticals, Inc. for a Phase 2 clinical study investigating an interferon-free, all-oral combination is part of the company's continued commitment to discover and develop innovative options for the treatment of HCV.

Faldaprevir and BI 207127 are investigational compounds and not approved by the FDA. Their safety and efficacy have not been established.

Hepatitis C is a blood-born infectious disease and a leading cause of chronic liver disease, transplant and failure that affects as many as 150 million people globally. In the United States, an estimated 4.1 million Americans have been infected with HCV, of which approximately 3.2 million have chronic HCV infection. Since 1999 there has been a significant increase in deaths due to chronic HCV, accounting for 15,000 deaths in the United States in 2007.

About Boehringer Ingelheim Pharmaceuticals, Inc.
Boehringer Ingelheim Pharmaceuticals, Inc., based in Ridgefield, CT, is the largest U.S. subsidiary of Boehringer Ingelheim Corporation (Ridgefield, CT) and a member of the Boehringer Ingelheim group of companies.

The Boehringer Ingelheim group is one of the world's 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 145 affiliates and more than 42,000 employees. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel products of high therapeutic value for human and veterinary medicine.

As a central element of its culture, Boehringer Ingelheim pledges to act socially responsible. Involvement in social projects, caring for employees and their families, and providing equal opportunities for all employees form the foundation of the global operations. Mutual cooperation and respect as well as environmental protection and sustainability are intrinsic factors in all of Boehringer Ingelheim's endeavors.

For more information, please visit and follow us on Twitter at

SOURCE Boehringer Ingelheim Pharmaceuticals, Inc.
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. European Medicines Agency accepts marketing authorization application for Boehringer Ingelheim and Eli Lilly and Companys empagliflozin*, an investigational type 2 diabetes treatment
2. Boehringer Ingelheim and Eli Lilly and Company submit new drug application to FDA for empagliflozin, an investigational type 2 diabetes treatment
3. Boehringer Ingelheim Announces Interim Results Evaluating Virologic Response Rates in HCV/HIV Co-Infected Patients Treated with Faldaprevir
4. Boehringer Ingelheim Cares Foundation Launches Online Giving Report
5. Boehringer Ingelheim Presents Efficacy Data for Tiotropium in Symptomatic Asthma Patients in Relation to Allergic Status
6. Pharmaceutical Leader Boehringer Ingelheim Selects Republica as Cross-Cultural Marketing Agency
7. Boehringer Ingelheim Selects ChemAxon to Power Next-Generation Global Cheminformatics Platform
8. FDA Advisory Committee Recommends Approval for Boehringer Ingelheims Olodaterol for Maintenance Treatment of COPD
9. Boehringer Ingelheim and Ashoka Changemakers Launch Competition to Find Business Models that Transform Health Systems
10. Boehringer Ingelheim Enrolls First Patients in Pivotal Phase 3 Interferon-Free Hepatitis C Trial Program
11. Boehringer Ingelheim Presents New Phase II Data for Volasertib in Adult Patients with AML
Post Your Comments:
(Date:11/26/2015)... 2015 Research and Markets ( ) ... Care Market by Type (Dressings, Therapy Devices, Active Wound ... Out-Patient Facility), and Geography - Global Forecast to 2020" ... --> --> The purpose of this ... of the global advanced wound care market. It involves ...
(Date:11/26/2015)... DUBLIN , Nov. 26, 2015 ... the addition of the "2016 Future Horizons ... Monitoring (TDM) Market: Supplier Shares, Country Segment Forecasts, ... offering. --> ... comprehensive analysis of the Italian therapeutic drug monitoring ...
(Date:11/25/2015)... SYDNEY , Nov. 26, 2015  The total global ... nearly 7% over 2015-2016. Latin America ... Asia , (excluding Japan ), is ... continues to face increased healthcare expenditure. In 2013-2014, ... expenditure declined from 43.5% in 2008-2009 to 41.2% in 2013-2014. ...
Breaking Medicine Technology:
(Date:11/28/2015)... , ... November 28, 2015 , ... Beginning November 30th at 6:00 a.m. EST until ... most savings. , With possible savings of up to 20% off orders $80 or more ... of the website every few hours. , As a competitive e-commerce website for skin care ...
(Date:11/27/2015)... CO (PRWEB) , ... November 27, 2015 , ... According ... cities are not changing the way that they are handling security in light of ... police and security presence in an attempt to stop an attack from reaching U.S. ...
(Date:11/27/2015)... County, CA (PRWEB) , ... November 27, 2015 , ... ... season , The company is offering customers 10% off of their purchase of lice ... any treatment at full price. According to a company spokesperson. “Finding lice is a ...
(Date:11/27/2015)... ... November 27, 2015 , ... ... well-respected Microsoft Dynamics SL User Group (MSDSLUG). Recognized as Microsoft’s official group for ... of Microsoft Dynamics SL software users, partners, industry experts and representatives. Intellitec Solutions’ ...
(Date:11/27/2015)... ... November 27, 2015 , ... The men and women on ... organizations in the country. They have overseen financial turnarounds, shown commitment to their ... healthcare industry as a whole through their advocacy and professional efforts. , Becker's ...
Breaking Medicine News(10 mins):