Boehringer Ingelheim completes patient entry for Phase III trial programme in Hepatitis C

Boehringer Ingelheim completes patient entry for Phase III trial programme in Hepatitis C

For media outside the U.S.
INGELHEIM, Germany, December 9th, 2011 - Boehringer Ingelheim today announced that the final patient has been randomised to treatment in the large-scale Phase III clinical trial programme for BI 201335, its investigational, oral protease inhibitor for the treatment of chronic hepatitis C virus (HCV).

The extensive study programme is underway at more than 350 sites in 15 countries and together encompasses nearly 2,000 treatment-experienced as well as treatment-naïve patients. Key regions in the programme include the European Union, Japan, U.S., Canada, Taiwan, Korea and Russia.
The programme consists of three Phase III trials, that will be conducted to evaluate BI 201335 plus the standard backbone treatment, pegylated interferon (pegIFN) and ribavirin (RBV) in patients with chronic genotype-1 HCV. Most HCV patients are infected with genotype-1 virus and belong to the most challenging HCV group to treat. The study programme evaluates "sustained viral response" (SVR) as the primary clinical endpoint, which is considered viral cure. Results from the Phase III studies are expected in the first half of 2013.

The U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the entire BI 201335 programme. Fast Track is a process designed to facilitate the development and expedite the review of drugs to treat serious diseases and fill an unmet medical need. The purpose is to get important new drugs to patients earlier.
"We are progressing our BI 201335 programme with a high priority to leverage its potential to improve cure rates in HCV treatment," said Professor Klaus Dugi, Corporate Senior Vice President Medicine at Boehringer Ingelheim. "We believe our HCV-pipeline may become an important tool to fight a chronic disease that affects over 170 million people worldwide."

Phase IIb results presented last month showed that the interferon-free combination of BI 201335, with Boehringer Ingelheim's polymerase inhibitor BI 207127 (SOUND-C2), led to 76% of patients achieving a virological response at week 12, with 63% achieving SVR12 (undetectable virus, 12 weeks post-treatment) with 16 weeks treatment. These results were presented at the American Association for the Study of Liver Diseases (AASLD) 2011 Liver Meeting in San Francisco, USA, alongside SILEN-C1 and SILEN-C3 study results which showed the potential for BI 201335/ PegIFN/RBV to shorten treatment duration and improve the likelihood of viral cure (SVR). These Phase IIb results provide a strong basis for further development as BI 201335 progresses through Phase III.


SOUND-C2 is an open-label, randomised, Phase IIb study where 362 treatment-naïve GT1 HCV patients were randomised into five interferon-free treatment groups, each with 120mg BI 201335 once daily but with different dosing of BI 207127 and treatment durations as follows:

BI 201335 120mg QD + BI 207127 600mg TID + RBV for 16 weeks;
BI 201335 120mg QD + BI 207127 600mg TID + RBV for 28 weeks;
BI 201335 120mg QD + BI 207127 600mg TID + RBV for 40 weeks;
BI 201335 120mg QD + BI 207127 600mg BID + RBV for 28 weeks; or
BI 201335 120mg QD + BI 207127 600mg TID without RBV for 28 weeks.
SILEN-C1 is a double-blind, placebo-controlled trial, that randomised 429 treatment-naïve GT1 HCV patients (1:1:2:2) to receive either placebo or
BI 201335 120 mg with three days Lead-in (LI) of PegIFN/RBV, BI 201335 240 mg QD with three days LI or BI 201335 mg 240mg QD without LI. In each treatment group, BI 201335 was given for 24 weeks together with PegIFN/RBV for 24 or 48 weeks. Patients were evaluated for SVR according to various baseline characteristics.

In this open-label Phase II trial, 159 treatment-naïve GT1 HCV patients were randomised to receive 120 mg QD BI 201335 for 12 or 24 weeks, each after three days lead-in (LI) with pegylated interferon and ribavirin (PegIFN/RBV). In both groups, PegIFN/RBV was given for 24 weeks. Patients who did not achieve an eRVR, continued PegIFN/RBV to week 48. eRVR was defined as viral load less than 25 IU/mL at week 4 and undetectable at weeks 8-18.
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 3-4 million new infections occurring each year. Only about 20-45% of patients clear the virus in the acute phase. Of the remaining chronically infected patients, 20% will develop cirrhosis within a mean of 20 years. The mortality rate after cirrhosis has developed is 2-5% 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 7,500 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 longstanding history in virology drug development, including compounds for the treatment of HIV (VIRAMUNE® (nevirapine) tablets/oral suspension, the first approved HIV non-nucleoside reverse transcriptase inhibitor (NNRTI) and Aptivus®, an HIV protease inhibitor). The company has a well established research centre in Laval, Canada, dedicated to virology research since the early 1990's, and is committed to developing new therapies for virological diseases with a high unmet medical need.
Boehringer Ingelheim in Hepatitis C Virus (HCV)
Boehringer Ingelheim has a dedicated HCV treatment development programme, called HCVersoTM, which at its core, aims to reverse the existing HCV paradigm. The ultimate aim of this programme is to deliver improved HCV treatment outcomes for patients whilst breaking down the barriers of current treatment regimens.

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 IIb (SILEN-C studies). This Phase II programme supports the investigation of BI 201335 in Phase III trials currently ongoing. Boehringer Ingelheim is also developing BI 207127, an NS5B RNA-dependent polymerase inhibitor that has completed Phase I clinical trials. Phase II trials evaluating BI 207127 with BI 201335 in interferon-sparing regimens, both with and without ribavirin, are currently underway.

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 42,000 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.

As a central element of its culture, Boehringer Ingelheim pledges to act socially responsible. 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 2010, Boehringer Ingelheim posted net sales of about 12.6 billion euro while spending almost 24% of net sales in its largest business segment Prescription Medicines on research and development.

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