Positive Phase 2 results reported with Boehringer Ingelheim’s investigational HCV protease inhibitor in both previously treated and untreated patients

BI 201335 once-daily at 240mg plus SOC provided positive Phase 2 results in this very difficult-to-treat patient population. As is seen in SILEN-C1, a three-day LI with SOC was associated with decreased viral response. Phase 3 trials of BI 201335 are in preparation.

The most frequent dose-dependent AEs in BI 201335 treatment groups were gastrointestinal disorders, jaundice resulting from unconjugated hyperbilirubinemia, and mild to moderate rash or photosensitivity. Serious or severe AEs were reported more frequently in the BI 201335 240mg BID with LI group. Discontinuations due to adverse events ranged from 4 percent in the BI 201335 240mg QD without LI group to 23 percent in the BI 201335 240mg BID with LI group.

Additional HCV Studies to be Presented at EASL

• SVR and pharmacokinetics of the HCV protease inhibitor BI 201335 with PegIFN/RBV in HCV genotype-1 patients with compensated liver cirrhosis and non-response to previous PegIFN/RBV
  (Poster #1231. S. Pol, et al., April 2, 9:00 a.m.-6:00 p.m. CET)
• Mechanisms of isolated unconjugated hyperbilirubinemia induced by the HCV NS3/4A protease inhibitor BI 201335
  (Poster #1236. R. Sane, et al., April 2, 9:00 a.m.-6:00 p.m. CET)
• BI 201335 pharmacokinetics and early effect on viral load in HCV genotype-1 patients
  (Poster #1249. C. Yong, et al., April 2, 9:00 a.m.-6:00 p.m. CET)
• Preclinical characterization of the hepatitis C virus NS5B polymerase non-nucleoside inhibitor BILB 1941
  (Poster #1215. G. Kukolj, et al., April 2, 9:00 a.m.-6:00 p.m. CET)

About Hepatitis C Virus (HCV)
HCV is an infectious disease of the liver and is a leading cause of chronic liver disease and liver transplant. The number of individuals chronically infected with HCV globally has been estimated at 170 million, with three to four million new infections occurring each year. Only about 20-45 percent of patients clear the virus in the acute phase. Of the remaining chronically infected patients, 20 percent will develop cirrhosis within a mean of 20 years. The mortality rate after cirrhosis has developed is two to five percent per year. End-stage liver disease due to HCV infection currently represents the major cause for liver transplantation in the Western world.

About Boehringer Ingelheim in Virology
Boehringer Ingelheim has more than 6,900 scientists working in cross disciplinary teams within our global R&D network in six large therapeutic areas, including virology. In addition to its ongoing research program for HCV, Boehringer Ingelheim has a long-standing history in virology drug development, including compounds for the treatment of HIV. The company has a well established research center in Laval, Canada, dedicated to virology research since the early 1990's, and is committed to developing new therapies for virologic diseases with a high unmet medical need.

Boehringer Ingelheim in Hepatitis C Virus (HCV)
BI 201335 is an investigational oral HCV NS3/4A protease inhibitor, discovered from Boehringer Ingelheim's own research and development, which has completed clinical trials through Phase 2b (SILEN-C studies). This Phase 2 program supports the investigation of BI 201335 in Phase 3 trials. Boehringer Ingelheim is also developing BI 207127, an NS5B RNA-dependent polymerase inhibitor that has completed Phase 1 clinical trials. Phase 2 trials evaluating BI 207127 with BI 201335 in interferon-sparing regimens, both with and without ribavirin, are currently underway.

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 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.

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

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