Boehringer Ingelheim Announces Enrollment of First Patient in Phase 3 Trial for Lead Hepatitis C Compound

[Guest guest]

http://www.prnewswire.com/news-releases/boehringer-ingelheim-announces-enrollmen\

t-of-first-patient-in-phase-3-trial-for-lead-hepatitis-c-compound-120692924.html

Boehringer Ingelheim Announces Enrollment of First Patient in Phase 3 Trial for

Lead Hepatitis C Compound

Development program has been granted FDA Fast Track designation

RIDGEFIELD, Conn., April 26, 2011 /PRNewswire/ -- Boehringer Ingelheim

Pharmaceuticals, Inc. today announced that enrollment has commenced at North

American sites in its pivotal Phase 3 clinical trial program for BI 201335, the

Company's investigational, oral protease inhibitor for the treatment of chronic

hepatitis C virus (HCV). Phase 3 trials have begun recruiting to evaluate BI

201335 plus standard-of-care (SOC) in both treatment-naive and -experienced

patients with chronic genotype-1 HCV, the most challenging HCV genotype to

treat.(1) Results from the Phase 3 studies are expected in the first half of

2013.

The U.S. Food and Drug Administration (FDA) has granted Fast Track designation

for the development program for BI 201335. 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.(2)

" We are pleased to have begun enrolling patients at North American trial sites

as we continue development of BI 201335, " said Piliero, M.D., executive

director, Medical Affairs, Boehringer Ingelheim Pharmaceuticals, Inc. " We look

forward to initiating additional trials later this year in more patient

populations, including HCV-HIV coinfected patients, as we continue to advance

our HCV portfolio. "

BI 201335 U.S. Phase 3 Trials

There are currently three Phase 3 trials enrolling patients around the world

that together seek to enroll approximately 1,875 patients. Two of the three

trials have U.S. trial sites that together plan to enroll approximately 495

patients.

In the U.S., Study 1220.47 will enroll approximately 370 treatment-naive

genotype-1 HCV patients at 95 trial sites. This study will also include

additional sites in Canada, Taiwan and Korea. Study 1220.7 will enroll

approximately 125 treatment-experienced genotype-1 HCV patients who have failed

at least 12 weeks of prior treatment with SOC at 40 trial sites in the U.S. This

study also includes additional trial sites around the world. In treatment-naive

patients (Study 1220.47), BI 201335 will be dosed once-daily at either 120 mg or

240 mg for 12 or 24 weeks in combination with 24 or 48 weeks of pegylated

interferon and ribavirin, the current HCV SOC. In treatment-experienced patients

(Study 1220.7) BI 201335 will be dosed once-daily at 240 mg for 12 or 24 weeks

in combination with SOC for 48 weeks for prior partial and null responder

patients. Patients with prior relapse will be dosed with BI 201335 once-daily at

240 mg for 12 or 24 weeks in combination with SOC for 24 or 48 weeks total

duration. The primary endpoint of each trial is sustained viral response (SVR),

which is considered viral cure.(3)

For more information about clinical trials involving BI 201335, please visit

www.clinicaltrials.gov.

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.(1,4) 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.(5) Only about 20-45 percent of

patients clear the virus in the acute phase.(5) Of the remaining chronically

infected patients, 20 percent will develop cirrhosis within a mean of 20

years.(1) The mortality rate after cirrhosis has developed is two to five

percent per year.(6) End-stage liver disease due to HCV infection currently

represents the major cause for liver transplantation in the Western world.(1)

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.

About 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 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.

For more information, please visit http://us.boehringer-ingelheim.com and follow

us on Twitter at http://twitter.com/boehringerus.

References:

1.National Digestive Disease Information Clearing House (NDDICH), NIH. Chronic

Hepatitis C: Current Disease Management.

http://digestive.niddk.nih.gov/ddiseases/pubs/chronichepc/index.htm.

2.U.S. Food and Drug Administration (FDA). Fast Track Designation Request

Performance. http://www.fda.gov/AboutFDA/CentersOffices/CBER/ucm122932.htm.

3.American Association for the Study of Liver Disease Practice Guidelines:

Diagnosis, Management, and Treatment of Hepatitis C: An Update. Hepatology,

April 2009. http://www.natap.org/2009/HCV/aasld.pdf.

4.Centers for Disease Control and Prevention (CDC). Hepatitis C FAQs for the

Public. http://www.cdc.gov/hepatitis/C/cFAQ.htm.

5.World Health Organization (WHO): Europe. Hepatitis: Hepatitis C.

http://www.euro.who.int/en/what-we-do/health-topics/diseases-and-conditions/hepa\

titis/facts-and-figures/hepatitis-c.

6.Soriano, et al. New Therapies for Hepatitis C Virus Infection.

Clinical Infectious Disease, February 2009.

http://cid.oxfordjournals.org/content/48/3/313.full.

SOURCE Boehringer Ingelheim Pharmaceuticals, Inc.

[Guest guest]

http://www.prnewswire.com/news-releases/boehringer-ingelheim-announces-enrollmen\

t-of-first-patient-in-phase-3-trial-for-lead-hepatitis-c-compound-120692924.html

Boehringer Ingelheim Announces Enrollment of First Patient in Phase 3 Trial for

Lead Hepatitis C Compound

Development program has been granted FDA Fast Track designation

RIDGEFIELD, Conn., April 26, 2011 /PRNewswire/ -- Boehringer Ingelheim

Pharmaceuticals, Inc. today announced that enrollment has commenced at North

American sites in its pivotal Phase 3 clinical trial program for BI 201335, the

Company's investigational, oral protease inhibitor for the treatment of chronic

hepatitis C virus (HCV). Phase 3 trials have begun recruiting to evaluate BI

201335 plus standard-of-care (SOC) in both treatment-naive and -experienced

patients with chronic genotype-1 HCV, the most challenging HCV genotype to

treat.(1) Results from the Phase 3 studies are expected in the first half of

2013.

The U.S. Food and Drug Administration (FDA) has granted Fast Track designation

for the development program for BI 201335. 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.(2)

" We are pleased to have begun enrolling patients at North American trial sites

as we continue development of BI 201335, " said Piliero, M.D., executive

director, Medical Affairs, Boehringer Ingelheim Pharmaceuticals, Inc. " We look

forward to initiating additional trials later this year in more patient

populations, including HCV-HIV coinfected patients, as we continue to advance

our HCV portfolio. "

BI 201335 U.S. Phase 3 Trials

There are currently three Phase 3 trials enrolling patients around the world

that together seek to enroll approximately 1,875 patients. Two of the three

trials have U.S. trial sites that together plan to enroll approximately 495

patients.

In the U.S., Study 1220.47 will enroll approximately 370 treatment-naive

genotype-1 HCV patients at 95 trial sites. This study will also include

additional sites in Canada, Taiwan and Korea. Study 1220.7 will enroll

approximately 125 treatment-experienced genotype-1 HCV patients who have failed

at least 12 weeks of prior treatment with SOC at 40 trial sites in the U.S. This

study also includes additional trial sites around the world. In treatment-naive

patients (Study 1220.47), BI 201335 will be dosed once-daily at either 120 mg or

240 mg for 12 or 24 weeks in combination with 24 or 48 weeks of pegylated

interferon and ribavirin, the current HCV SOC. In treatment-experienced patients

(Study 1220.7) BI 201335 will be dosed once-daily at 240 mg for 12 or 24 weeks

in combination with SOC for 48 weeks for prior partial and null responder

patients. Patients with prior relapse will be dosed with BI 201335 once-daily at

240 mg for 12 or 24 weeks in combination with SOC for 24 or 48 weeks total

duration. The primary endpoint of each trial is sustained viral response (SVR),

which is considered viral cure.(3)

For more information about clinical trials involving BI 201335, please visit

www.clinicaltrials.gov.

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.(1,4) 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.(5) Only about 20-45 percent of

patients clear the virus in the acute phase.(5) Of the remaining chronically

infected patients, 20 percent will develop cirrhosis within a mean of 20

years.(1) The mortality rate after cirrhosis has developed is two to five

percent per year.(6) End-stage liver disease due to HCV infection currently

represents the major cause for liver transplantation in the Western world.(1)

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.

About 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 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.

For more information, please visit http://us.boehringer-ingelheim.com and follow

us on Twitter at http://twitter.com/boehringerus.

References:

1.National Digestive Disease Information Clearing House (NDDICH), NIH. Chronic

Hepatitis C: Current Disease Management.

http://digestive.niddk.nih.gov/ddiseases/pubs/chronichepc/index.htm.

2.U.S. Food and Drug Administration (FDA). Fast Track Designation Request

Performance. http://www.fda.gov/AboutFDA/CentersOffices/CBER/ucm122932.htm.

3.American Association for the Study of Liver Disease Practice Guidelines:

Diagnosis, Management, and Treatment of Hepatitis C: An Update. Hepatology,

April 2009. http://www.natap.org/2009/HCV/aasld.pdf.

4.Centers for Disease Control and Prevention (CDC). Hepatitis C FAQs for the

Public. http://www.cdc.gov/hepatitis/C/cFAQ.htm.

5.World Health Organization (WHO): Europe. Hepatitis: Hepatitis C.

http://www.euro.who.int/en/what-we-do/health-topics/diseases-and-conditions/hepa\

titis/facts-and-figures/hepatitis-c.

6.Soriano, et al. New Therapies for Hepatitis C Virus Infection.

Clinical Infectious Disease, February 2009.

http://cid.oxfordjournals.org/content/48/3/313.full.

SOURCE Boehringer Ingelheim Pharmaceuticals, Inc.