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Boehringer Ingelheim Pharmaceuticals, Inc. to Announce Pivotal Phase 3 Hepatitis C Data at the International Liver Congress


4/8/2013 7:21:57 AM

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 Presentation

Study

Lead Author

Presentation Details

STARTVerso 1

P. Ferenci

Embargoed until April 23 at 12:00PM CET (6:00AM ET)


Poster Presentations

Title

Lead 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. Zeuzem

Abstract 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

SOUND-C2

T. Asselah

Abstract 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
SOUND-C2

S. Olson

Abstract 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 http://us.boehringer-ingelheim.com and follow us on Twitter at http://twitter.com/boehringerus.

SOURCE Boehringer Ingelheim Pharmaceuticals, Inc.


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