Boehringer Ingelheim will announce pivotal Phase III hepatitis C data at the International Liver Congress (ILC / EASL)

For media outside of the U.S.A., UK and Canada only

Results from Boehringer Ingelheim´s pivotal STARTVerso TM1 Phase III hepatitis C clinical trial have been accepted for oral presentation at the International Liver Congress TM (ILC*) 2013, 24-28 April, Amsterdam. The data have also been selected for inclusion in the official ILC Press Conference on 24 April at 11:00 CEST. The abstract will be published online on 23 April at 12:00 CEST when the embargo is lifted.

The STARTVerso TM1 trial assessed faldaprevir+ (BI 201335), an investigational NS3/4A protease inhibitor that is taken orally once-daily in combination with pegylated interferon and ribavirin (PegIFN/RBV) versus placebo with PegIFN/RBV. The study was conducted in treatment-naïve genotype-1 patients, the most common and one of the most challenging HCV patient populations to cure.1 Faldaprevir was tested at two doses, 120mg and 240mg once daily, the primary endpoint was sustained virological response 12 weeks after planned end of treatment (SVR 12).

This faldaprevir based treatment regimen has the potential to improve viral cure rates and tolerability for the patient. Boehringer Ingelheim is developing faldaprevir, an optimised second generation protease inhibitor, as the core component for both interferon-based and interferon-free hepatitis C treatment regimens.

Three additional sub-analyses from the Phase IIb SOUND-C2 study will also be presented at the congress. The SOUND-C2 trial investigated the interferon-free combination of faldaprevir and BI 207127+, a potent investigational non-nucleoside NS5B polymerase inhibitor, with ribavirin. These data result from Boehringer Ingelheim´s comprehensive clinical trial program which includes a diverse population of hepatitis C patients. The company is dedicated to develop effective and well tolerated treatments recognising the high unmet need for more patient centric approaches in HCV.

Boehringer Ingelheim´s data due to be presented in poster form can be accessed through the congress website today: http://www.sessionplan.com/EASL2013/

Oral Presentations

First data from the
Phase III STARTVersoTM1 clinical trial;
investigating
faldaprevir (BI 201335) in combination with
pegylated interferon and ribavirin, in TN,
GT-1 HCV patients

24 April @ 11 CET
(as part of the
official ILC TM Press
Conference)

27 April @ 15:30 CET
(as part of the ILC TM
scientific programme)

Poster Presentations

An analysis of response
rates by fibrosis stage in patients treated
with faldaprevir, BI 207127 and ribavirin in
the SOUND-C2 study2

Abstract number 1227

27 April 09:00-18:00

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-C23

 Abstract number 1186

27 April 09:00-18:00

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-C24

Abstract number 1212

27 April 09:00-18:00

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

*International Liver Congress TM 2013: 48th Annual Meeting of the European Association for the Study of the Liver

+faldaprevir and BI 207127 are investigational compounds and not yet approved. Their safety and efficacy have not yet been fully established

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NOTES TO EDITORS

The Boehringer Ingelheim NewsHome: An innovative resource for journalists

The Boehringer Ingelheim hepatitis C www.NewsHome.com is now available and is the one-stop-shop for clear, concise and easy to understand information about hepatitis C.

Boehringer Ingelheim

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 44,000 employees. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel medications of high therapeutic value for human and veterinary medicine.

As a central element of its culture, Boehringer Ingelheim pledges to act socially responsibly. 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 endeavours.

In 2011, Boehringer Ingelheim achieved net sales of about 13.2 billion euro. R&D expenditure in the business area Prescription Medicines corresponds to 23.5% of its net sales. Updated 2012 data will be provided at Boehringer Ingelheim´s Annual Press Conference on 24 April 2013. If you are interested in attending please email: press@boehringer-ingelheim.com

For more information please visit www.boehringer-ingelheim.com

References:

1. Ferenci P. et al. STARTVersoTM1 data. To be presented at EASL 2013

2. Zeuzem S. et al. An analysis of response rates by fibrosis stage in patients treated with faldaprevir, BI 207127 and ribavirin in the SOUND-C2 study. To be presented at EASL 2013

3. Asselah T. et al. 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. To be presented at EASL 2013

4. Olsen. S. et al. Pharmacokinetic modelling of the relationship between sustained virological response and plasma concentrations of faldaprevir or BI 207127 in HCV GT1-infected patients in SOUND-C2. To be presented at EASL 2013