INGELHEIM, Germany–(BUSINESSWIRE)–
New data from Boehringer Ingelheim’s interferon-free SOUND-C3 study were
presented during the APASL Liver Week in Singapore. The Phase IIb study
investigated the efficacy and safety of faldaprevir+ and
deleobuvir+ (BI 207127) plus ribavirin in treatment-naïve
patients with genotype-1b (GT-1b) hepatitis C virus (HCV),1
one of the most common types of HCV globally.2

Results showed that 95% of genotype-1b (GT-1b) infected patients (19/20)
who received BI’s interferon-free combination therapy achieved viral
cure after 16 weeks of treatment.1 20% (4/20) of GT-1b
patients in the study had liver cirrhosis (an advanced form of liver
disease), all of whom achieved viral cure.1 Viral cure was
defined as a sustained viral response 12 weeks after completion of
treatment (SVR12).1 In contrast, patients with genotype-1a
(GT-1a) infection and host IL28b type CC (n=12) had a lower viral
response of 17% SVR12 (2/12), suggesting a need for treatment of greater
intensity for this population and confirming the decision to focus on
GT-1b patients in Phase III trials.

Eliminating injectable interferon from treatment regimens is a highly
desirable goal in HCV management as it can be challenging for patients
due to the long treatment duration and often severe side-effects.2
Up to 50% of patients may not be eligible for treatment with interferon
and many patients who are eligible cannot tolerate the side-effects.

“These promising results indicate the potential of our interferon-free
combination treatment to address an unmet medical need, and confirm our
decision to focus on GT-1b patients in our pivotal Phase III
interferon-free HCVerso™ trials,” said Professor Klaus Dugi, Senior Vice
President Medicine at Boehringer Ingelheim. “The inclusion of
difficult-to-cure patients such as those with liver cirrhosis and those
that are interferon ineligible demonstrates the comprehensive nature of
our clinical trial programme and supports our ultimate goal of making an
interferon-free future a reality for HCV patients.”

In SOUND-C3, optimising treatment (by removing a deleobuvir+ first
day loading dose and reducing treatment duration to 16 weeks) for
GT-1b-infected patients resulting in higher efficacy compared with
SOUND-C2.1 The SOUND-C2 study, presented in November 2012 at
the AASLD Congress, showed viral cure rates of up to 85% with different
interferon-free regimens of faldaprevir, deleobuvir+ and
ribavirin in HCV GT-1b infected patients.3

Overall tolerability in the SOUND-C3 trial was good with three patients
(9%) discontinuing treatment due to intolerance, and mild rash or nausea
being the most common side-effects.1 Adverse events of a
moderate or higher intensity were rare, with anaemia (16%), fatigue
(9%), vomiting (9%) and nausea (9%) being the most frequent adverse
events.1

Boehringer Ingelheim‘s pivotal Phase III interferon-free HCVerso™
programme includes three trials aiming to enrol approximately 1,100
treatment-naïve HCV GT-1b patients.4,5,6 The trial programme
includes patients who are interferon ineligible and those with liver
cirrhosis; results are expected in Q2 2014.

Other BI news at APASL

Results from Boehringer Ingelheim’s interferon-based Phase III
STARTVerso™ trials were presented yesterday at the APASL congress by
Professor Masao Omata. A post-hoc sub-analysis of patients from Asia in
the STARTVerso™1 and 2 trials demonstrated that 88% (172/196) of GT-1a
and GT-1b 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.7 In addition, 94% of patients on
faldaprevir were able to stop all treatments after 24 weeks of therapy.7
Currently, interferon treatment without protease inhibitors is still the
standard treatment in most parts of Asia, lasting 48 weeks for GT-1
infected patients.

# # #

+faldaprevir and deleobuvir (BI 207127) are investigational
compound and not yet approved. Their safety and efficacy have not yet
been fully established

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 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.2
Chronic hepatitis C is a major public health issue and one of the most
prevalent infectious diseases worldwide, affecting around 170 million
people,8 with 3-4 million new cases occurring each year.9

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.10 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% will develop liver cirrhosis,
of which 2-5% will die every year.11 Advanced liver disease
due to hepatitis C currently represents the main cause for liver
transplantation in the western world.11

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. Zeuzem, S. et al. Interferon-Free Treatment with
Faldaprevir, BI207127 and Ribavirin in SOUND-C3: 95% SVR12 in HCV-GT1b.
Presented at APASL Liver Week, 6-10 June, 2013

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

3. Zeuzem S. et al Interferon (IFN)-free combination
treatment with the HCV NS3/4A protease inhibitor BI 201335 and the
nonnucleoside NS5B inhibitor BI 207127 ± ribavirin (R): Final results of
SOUND-C2 and predictors of response. Abstract#232 presented at the 63rd
Annual Meeting of the American Association for the Study of Liver
Diseases (AASLD), 9 – 13 November

4. ClinicalTrials.gov. IFN-free Combination Therapy in
HCV-infected Patients Treatment-naive:HCVerso1. http://clinicaltrial.gov/ct2/show/NCT01732796?term=faldaprevir+bi+207127rank=3
[Last accessed 06/06/13]

5. ClinicalTrials.gov. Phase 3 Study of BI 207127 in
Combination With Faldaprevir and Ribavirin for Treatment of Patients
With Hepatitis C Infection, Including Patients Who Are Not Eligible to
Receive Peginterferon: HCVerso2. http://clinicaltrial.gov/ct2/show/NCT01728324?term=faldaprevir+bi+207127rank=2
[Last accessed 06/06/13]

6. ClinicalTrials.gov. BI 207127 / Faldaprevir Combination
Therapy in Hepatic Impairment (Child-Pugh B) Patients With Genotype 1b
Chronic Hepatitis C Infection: HCVerso3 http://clinicaltrial.gov/ct2/show/NCT01830127?term=hcverso3rank=1
[Last accessed 06/06/13]

7. 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

8. 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]

9. 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]

10. 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]

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