INGELHEIM, Germany–(BUSINESSWIRE)–
New findings presented today during the APASL Liver Week in Singapore,
highlighted the efficacy and safety of faldaprevir+ plus
pegylated interferon and ribavirin (PegIFN/RBV) in treatment-naïve
patients with genotype-1 hepatitis C virus (HCV) in Asia.1
This post-hoc sub-analysis of the Phase III STARTVerso™1 and 2 trials
showed that both doses of faldaprevir were associated with high viral
cure rates and a shorter treatment duration in this particular patient
group.1 The STARTVerso™1 and 2 trials are part of the global
STARTVerso™ trial programme which includes four Phase III trials with
more than 2,200 treatment-naïve, treatment-experienced and HIV
co-infected patients with HCV.2,3,4,5

The prevalence of HCV infection is particularly high in Asia and there
remains a significant unmet need for effective treatment options.6 This
post-hoc sub-analysis included 243 patients with HCV from three Asian
countries (Japan, Korea and Taiwan). The primary end point was viral
cure 12 weeks after completion of treatment (SVR12). Key findings reveal
that 88% (172/196) of patients treated with faldaprevir (FDV 120mg or
240mg) plus PegIFN/RBV achieved viral cure compared with 62% (29/47)
treated with placebo plus PegIFN/RBV.1 Even at the lower
dose, 100% of patients from Taiwan (18/18) achieved viral cure when
treated with faldaprevir (120mg) plus PegIFN/RBV.1 Patients
from Japan and Korea also achieved high viral cure rates of 85% (44/52)
and 86% (25/29) respectively, with the 120mg dose. High efficacy was
also seen with the higher 240mg dose of faldaprevir.1

“These data are very encouraging for physicians and patients in Asia as
there is a large population of treatment-naïve patients in this region
in need of more effective treatment options,” said Professor Masao
Omata, Yamanashi Central and Kita Hospitals, Yamanashi, Japan and lead
author of the STARTVerso™ sub-analysis in Asia. “The results are
particularly relevant given that HCV presents a huge health burden in
Asia. The viral cure rates of close to 90% in patients infected with the
difficult-to-cure genotype-1 HCV highlight the potential of faldaprevir
to address this unmet medical need.”

Findings also showed 95% and 93% of patients who received faldaprevir+120mg
and 240mg respectively plus PegIFN/RBV achieved Early Treatment Success
(ETS) and were eligible for shorter total treatment duration of only 24
weeks.1 ETS was determined by sufficiently low virus levels
at week 4 and week 8 of treatment (as defined in the protocol*).Of
those patients who achieved ETS, 91% (120mg) and 92% (240mg) of patients
went on to achieve viral cure (SVR12).1

In addition, both faldaprevir+ doses were well tolerated and
adverse events that led to discontinuation of all study medications was
5% for 240mg faldaprevir+-treated patients and 3% for 120mg
versus 2% for placebo-treated patients.1 Rash (9%, 8%, 13%)
and gastrointestinal side-effects (4%, 8%, 21%) were the most common
Grade 2-4 adverse events in the placebo, faldaprevir+ 120mg
and faldaprevir+ 240mg arms respectively.1 Elevations
in unconjugated bilirubin were observed in all faldaprevir+
dose groups, but these were reversible and not accompanied by increases
in liver enzymes. No incremental reduction in haemoglobin was observed
compared with PegINF/RBV alone.1

“These data add to the growing body of evidence for faldaprevir and
reinforce the comprehensive nature of the STARTVerso™ clinical trial
programme,” said Professor Klaus Dugi, Senior Vice President Medicine at
Boehringer Ingelheim. “Addressing the diversity of HCV patients
worldwide is essential to drug development and individualised patient
management in this field. We look forward to adding to our robust
clinical data for faldaprevir with results from the STARTVerso™2, 3 and
4 studies.”

Overall results of the STARTVerso™1 study, which include patients from
Europe and Japan, were presented at the International Liver Congress
(ILC/EASL) in April 2013. Results show up to 80% of patients treated
with faldaprevir+ and PegIFN/RBV achieved viral cure compared
with 52% of patients treated with placebo plus PegIFN/RBV.7
At both doses (120mg and 240mg), 87% to 89% of patients met criteria to
stop all treatment after 24 weeks and 86% to 89% of these patients went
on to achieve SVR12.7 Faldaprevir+ was well
tolerated at both doses; at the lower dose, side-effect related
treatment discontinuation was similar to placebo.7

Additional results from the STARTVersoTM programme are
expected to be presented at large international meetings in 2013 and
2014; data from STARTVerso™2, which include patients from USA, Canada,
Taiwan and Korea, and data from STARTVerso™3 and 4, investigating
treatment-experienced and HIV co-infected HCV patients.3,4,5

# # #

+faldaprevir is an investigational compound and not yet
approved. Its safety and efficacy have not yet been fully established

*Criteria for shortened treatment duration is early treatment success =
week 4 HCV below limit of quantification [BLQ] and week 8 HCV below
limit of detection [BLD]

NOTES TO EDITORS

The Boehringer Ingelheim NewsHome: An innovative resource for
journalists

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

About STARTVerso™1 and 2

STARTVerso™1 and 2 are double-blind, placebo-controlled Phase III trials
of faldaprevir+ in combination with PegIFN/RBV. The
studies enroled and treated 1,310 (652 in STARTVerso™1 and 658 in
STARTVerso™2) treatment-naïve patients who were infected with chronic
genotype-1 hepatitis C. STARTVerso™1 included patients from Europe and
Japan; STARTVerso™2 included patients from USA, Canada, Taiwan and
Korea. Patients were randomised to receive a once-daily dose of 120mg
faldaprevir+, 240mg faldaprevir+ or
placebo in addition to PegIFN and RBV.

Treatment duration depended on whether patients met criteria for
protocol-defined early treatment success (ETS) (week 4 below limit of
quantification [BLQ] and week 8 below limit of detection [BLD]). All
patients who met these criteria received 12 weeks of faldaprevir+
with 24 weeks of PegIFN/RBV. Patients who did not meet the criteria were
re-randomised to receive 24 weeks of faldaprevir+
or 12 weeks of faldaprevir+ followed by 12 weeks of
placebo in the 120mg dose group or 12 weeks of faldaprevir+
in the 240mg dose group; both groups received 48 weeks of PegIFN/RBV.
Patients in the control arm received 24 weeks of placebo with 48 weeks
of PegIFN/RBV.

About Hepatitis C

Hepatitis C is a blood-borne infectious disease caused by the hepatitis
C virus which lives and replicates in the liver. Hepatitis C is a
leading cause of chronic liver disease, liver cancer and transplantation.8
Chronic hepatitis C is a major public health issue and one of the most
prevalent infectious diseases worldwide, affecting around 170 million
people,9 with 3-4 million new cases occurring each year.10

It is common for hepatitis C patients to remain undiagnosed due to the
initial unspecific symptoms of the disease.Consequently, a
large number of patients first present to their physician when they
experience symptoms or already have liver disease.11 Patients
with advanced liver disease are challenging to cure, yet have the
greatest need for more effective and better tolerated treatments.

Of patients with chronic hepatitis C, 20 percent will develop liver
cirrhosis, of which 2-5 percent will die every year.12
Advanced liver disease due to hepatitis C currently represents the main
cause for liver transplantation in the western world.12

About Boehringer Ingelheim in hepatitis C

Through pioneering science, Boehringer Ingelheim is striving to find
answers to the pressing challenges still faced by the diverse population
of hepatitis C patients. The company’s comprehensively designed
hepatitis C clinical trial programme includes a broad range of patients,
including the challenging to cure, that clinicians see every day in
clinical practice.

Boehringer Ingelheim is developing faldaprevir+, an
optimised second generation protease inhibitor, as the core component
for both interferon-based and interferon-free treatment regimens.

Interferon-based therapy with faldaprevir+ has the
potential to improve cure rates with the added convenience of once-daily
dosing and no dietary requirements for intake. Faldaprevir+
has proven efficacy in a broad range of genotype-1a and 1b hepatitis C
patients. The STARTVersoTM trial programme, which includes
treatment-naïve, treatment-experienced and HIV co-infected patients with
hepatitis C virus, is nearly complete.

Deleobuvir (BI 207127) is a potent investigational non-nucleoside NS5B
polymerase inhibitor, specifically optimised to treat patients with
genotype-1b hepatitis C virus. Phase III HCVersoTM trials,
investigating the interferon-free regimen of deleobuvir in combination
with faldaprevir+ and ribavirin, are well underway.

As part of Boehringer Ingelheim’s long-term commitment to hepatitis C,
the company is also evaluating other combinations of investigational
hepatitis C compounds that work in different ways. Boehringer
Ingelheim’s recent collaboration with Presidio Pharmaceuticals, Inc. for
a Phase II clinical study investigating an interferon-free, all-oral
combination is part of the company’s continued exploration to discover
and develop innovative options for the treatment of HCV.

Boehringer Ingelheim

The Boehringer Ingelheim group is one of the world’s 20 leading
pharmaceutical companies. Headquartered in Ingelheim, Germany, it
operates globally with 140 affiliates and more than 46,000 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.

Social responsibility is a central element of Boehringer Ingelheim’s
culture. 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.

In 2012, Boehringer Ingelheim achieved net sales of about 14.7 billion
euro. RD expenditure in the business area Prescription Medicines
corresponds to 22.5% of its net sales.

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

References

1. Omata, M. et al. Faldaprevir plus pegylated-interferon and ribavirin
in chronic HCV genotype-1 treatment-naïve patients: subanalysis of
patients from Japan, Taiwan and South Korea. Presented at APASL Liver
Week, 6-10 June, 2013

2. ClinicalTrials.gov. Efficacy and Safety of BI 201335 in Combination
With Pegylated Interferon-alpha and Ribavirin in Treatment-naïve
Genotype 1 Hepatitis C Infected Patients. http://clinicaltrials.gov/ct2/show/NCT01343888?term=bi+201335rank=4
[Last accessed 28/05/13]

3. ClinicalTrials.gov. BI 201335 Used in Treatment Naive Patients
Infected With Genotype 1 Chronic Hepatitis C Infection. http://clinicaltrials.gov/ct2/show/NCT01297270?term=bi+201335rank=5
[Last accessed 28/05/13]

4. ClinicalTrials.gov. Pivotal Trial Treatment Experienced Patient
Infected With Hepatitis C Virus (HCV) Genotype 1 (GT1). http://clinicaltrials.gov/ct2/show/NCT01358864?term=bi+201335rank=14
[Last accessed 28/05/13]

5. ClinicalTrials.gov. Phase III Trial of BI 201335 in Treatment Naive
(TN) and Relapser Hepatitis C Virus (HCV)- Human Immunodeficiency Virus
(HIV) Coinfected Patients. http://clinicaltrials.gov/ct2/show/NCT01399619?term=bi+201335+HIVrank=1
[Last accessed 28/05/13]

6. Sievert W, et al. A systematic review of hepatitis C virus
epidemiology in Asia, Australia and Egypt. Liver Int 2011; 31(Suppl.
2):61-80

7. Ferenci, P. et al. Faldaprevir plus pegylated interferon alfa-2A and
ribavirin in chronic HCV genotype-1 treatment-naïve patients: final
results from STARTVerso1, a randomised, double blind, placebo-controlled
Phase III trial. Presented at the International Liver CongressTM (ILC),
The 48th Annual Meeting of the European Association for the Study of the
Liver (EASL), 24-28 April, 2013

8. World Health Organisation. Hepatitis C. 2002 http://www.who.int/csr/disease/hepatitis/Hepc.pdf
[Last accessed on 28/05/13]

9. Centers for Disease Control and Prevention (2012) Hepatitis C
available at: http://wwwnc.cdc.gov/travel/yellowbook/2012/chapter-3-infectious-diseases-related-to-travel/hepatitis-c.htm
[Last accessed on 28/05/13]

10. World Health Organisation. Hepatitis C Fact Sheet. Updated July 2012 http://www.who.int/mediacentre/factsheets/fs164/en/index.html
[Last accessed on 28/05/13]

11. Chen S.L., Morgan T.R. The Natural History of Hepatitis C Virus
(HCV) Infection. Int J Med Sci 2006; 3:47-52. Available from http://www.medsci.org/v03p0047.htm
[Last accessed on 28/05/13]

12. Soriano, Vincent et al. New Therapies for Hepatitis C Virus
Infection. Clinical Infectious Disease, February 2009