New Boehringer Ingelheim Hepatitis C Data to Be Presented at AASLD

Five abstracts accepted for presentation – including data about interferon-free treatment regimens

INGELHEIM, Germany--(BUSINESS WIRE)--For Non-US Media Only

Boehringer Ingelheim announced today that new data from its hepatitis C virus (HCV) portfolio will be presented in scientific sessions at The Liver Meeting® 2011, the 62^nd Annual Meeting of the American Association for the Study of Liver Diseases (AASLD), taking place November 4 – November 8 in San Francisco, CA. The abstracts are published online at www.aasld.org.

Key data presented will include a week 12 interim analysis of SOUND-C2, a Phase IIb study evaluating an interferon-free combination of its protease inhibitor BI 201335 and its polymerase inhibitor BI 207127 – with and without ribavirin in treatment-naïve HCV infected patients.¹ In addition, SILEN-C1 and SILEN-C3 data will further assess the efficacy and safety of BI 201335 in treatment-naïve HCV-infected patients, in combination with pegylated interferon alfa-2a and ribavirin (PegIFN/RBV).^2,3

SOUND-C2
In SOUND-C2, 362 treatment-naïve patients with chronic genotype-1 HCV infections were randomised into five interferon-free treatment arms, each with 120mg BI 201335 once daily (QD) but with different dosings of BI 207127 and ribavirin as follows:

• 120 mg QD BI 201335 combined with 600 mg TID (thrice daily) BI 207127 and RBV for 16 weeks
• 120 mg QD BI 201335 combined with 600 mg TID BI 207127 and RBV for 28 weeks
• 120 mg QD BI 201335 combined with 600 mg TID BI 207127 and RBV for 40 weeks
• 120 mg QD BI 201335 combined with 600 mg BID (twice daily) BI 207127 and RBV for 28 weeks
• 120 mg QD BI 201335 combined with 600 mg TID BI 207127 for 28 weeks (no RBV)

The interim results will provide early virological response rates for all treatment arms of the novel interferon-free combination of BI 201335/BI 207127/ribavirin and are due to be presented by Stefan Zeuzem, M.D., Chief of the Department of Medicine and Professor of Medicine at the Johann Wolfgang Goethe University Hospital in Frankfurt, Germany and lead investigator of the study.

SILEN-C1
In SILEN-C1, 429 treatment-naïve patients with chronic genotype-1 HCV infections were randomised to the following treatment groups:

• Placebo
• BI 201335 120 mg QD with 3 days lead-in (LI) of PegIFN/RBV
• BI 201335 240 mg QD/LI
• BI 201335 240 mg QD without LI

In each arm, BI 201335 or placebo were given for 24 weeks together with PegIFN/RBV for 24 or 48 weeks. Results presented at AASLD will include an analysis of sustained virological response across different baseline factors, including difficult to treat HCV cases.

SILEN-C3
In SILEN-C3, 159 treatment-naïve genotype-1 patients were randomised to the following treatment groups:

• BI 201335 120mg QD for 12 weeks with 3 days lead-in of PegIFN/RBV
• BI 201335 120mg QD for 24 weeks with 3 days lead-in of PegIFN/RBV

In each arm, PegIFN/RBV was given for 24 or 48 weeks. Results presented at AASLD will provide an analysis of 12 versus 24 weeks of treatment with BI 201335.

Titles for accepted abstracts are below and full results and conclusions for these abstracts will be shared at AASLD at the times specified.

Late breaking poster presentation

• Virologic response to an interferon-free regimen of BI 201335 and BI 207127, with and without ribavirin, in treatment-naïve patients with chronic genotype-1 HCV infection: Week 12 interim results of the SOUND-C2 study ¹
  (Poster LB-15. Zeuzem, et al. November 7, 8:00 a.m. - 5:30 p.m. PT)

Oral presentations

• SILEN-C3: Treatment for 12 or 24 weeks with BI 201335 combined with peginterferon alfa-2a and ribavirin (P/R) in treatment-naïve patients with chronic genotype-1 HCV infection
  (Abstract 39. D. Dieterich, et al. November 6, 4:15 p.m. - 4:30 p.m. PT) ³
• Treatment with the second generation HCV protease inhibitor BI 201335 results in high and consistent SVR rates – results from SILEN-C1 in treatment-naïve patients across different baseline factors
  (Abstract 226. M.S. Sulkowski, et al. November 8, 8:45 a.m. - 9:00 a.m. PT) ²
• High sustained virologic response following interferon-free treatment of chronic HCV GT1 infection for 4 weeks with HCV protease inhibitor BI 201335, polymerase inhibitor BI 207127 and ribavirin, followed by BI 201335 and PegIFN/ribavirin – the SOUND-C1 study
  (Abstract 249. S. Zeuzem, et al. November 8, 11:15 a.m. - 11:30 a.m. PT) ⁴

Poster presentation

• Characterization of HCV NS3 variants that emerged during virologic breakthrough and relapse from BI 201335 phase 2 SILEN-C1 study
  (Poster 1339. G. Kukolj, et al., November 7, 8:00 a.m. - 5:30 p.m. PT) ⁵

The results from the HCV portfolio at AASLD underscore the promise of the company’s pipeline as Boehringer Ingelheim continues to focus on the real-world challenges faced by HCV patients globally. ^1–5

Boehringer Ingelheim is continuing its long heritage in virology and is dedicated to developing new medicines for HCV patients. BI 201335 and BI 207127 are being investigated with the goal of improving cure rates ^{1, 2, 3, 4, 6} for more HCV patients, including those traditionally difficult to treat. ^6–8

For more information on Boehringer Ingelheim’s hepatitis portfolio, please visit www.boehringer-ingelheim.com and follow us on Twitter. www.twitter.com/boehringer.

Boehringer Ingelheim
The Boehringer Ingelheim group is one of the world’s 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 142 affiliates in 50 countries and more than 41,500 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.

Within the company’s global research network, Virology is one of the seven R&D areas with focus on Hepatitis C.

In 2009, Boehringer Ingelheim posted net sales of 12.7 billion euro (US $17.7 billion) while spending 21% of net sales in its largest business segment, Prescription Medicines, on research and development.

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References

1. Zeuzem, Stefan et al. Virologic response to an interferon-free regimen of BI 201335 and BI 207127, with and without ribavirin, in treatment-naive patients with chronic genotype-1 HCV infection: Week 12 interim results of the SOUND-C2 study.
2. Sulkowski, Mark et al. Treatment with the 2nd generation HCV protease inhibitor BI 201335 results in high and consistent SVR rates – results from SILEN-C1 in treatment-naïve patients across different baseline factors.
3. Dieterich, Douglas et al. SILEN-C3: Treatment for 12 or 24 weeks with BI 201335 combined with peginterferon alfa-2a and ribavirin (P/R) in treatment-naïve patients with chronic genotype-1 HCV infection.
4. Zeuzem, Stefan et al. High sustained virologic response following interferon-free treatment of chronic HCV GT1 infection for 4 weeks with HCV protease inhibitor BI 201335, polymerase inhibitor BI 207127 and ribavirin, followed by BI 201335 and PegIFN/ribavirin – the SOUND-C1 study.
5. Kukolj, G. et al. Characterization of HCV NS3 variants that emerged during virologic breakthrough and relapse from BI 201335 phase 2 SILEN-C1 study.
6. Soriano, Vincent et al. Directly acting antivirals against hepatitis C virus. Journal of Antimicrobial Chemotherapy. 2011;66:1673-1686.
7. American Association for the Study of Liver Disease Practice Guidelines: Diagnosis, Management, and Treatment of Hepatitis C: An Update. Hepatology, April 2009.
8. National Institutes of Health Consensus Development Program: Management of Hepatitis C, 2002. http://consensus.nih.gov/2002/2002Hepatitisc2002116html.htm.