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Pivotal Phase 3 Data from Boehringer Ingelheim Hepatitis C Portfolio to be Presented at 64th Annual AASLD Meeting

October 1, 2013

RIDGEFIELD, Conn., Oct. 1, 2013 /PRNewswire/ — New data from Boehringer Ingelheim’s hepatitis C virus (HCV) clinical development program have been accepted for presentation at the 64(th) Annual Meeting of the American Association for the Study of Liver Diseases (AASLD), also known as The Liver Meeting(®), taking place November 1-5 in Washington, D.C.

Presentations will include data from several studies evaluating Boehringer Ingelheim’s investigational compound, faldaprevir, including final results from the STARTVerso((TM) )1, 2 and 3 pivotal trial programs (NCT01343888, NCT01297270, NCT01358864) in treatment-naive and treatment-experienced patients. End-of-treatment results from STARTVerso 4((TM)) (NCT01399619)( )evaluating HIV/HCV co-infected patients will also be presented.

Additionally, data will be presented from studies evaluating drug-drug interactions of faldaprevir with common birth control and anti-addiction medications, as well as a study evaluating faldaprevir pharmacokinetics, safety, and tolerability in patients with renal impairment. Final results from SOUND-C3 (NCT01132313), a Phase 2b study from Boehringer Ingelheim’s interferon-free development program, will also be presented.

Together these studies explore the use of Boehringer Ingelheim’s investigational HCV compounds in a broad range of patients with HCV, in addition to helping understand the potential for interactions with several commonly used medications. Also, they offer insight into the clinical profile of the compounds for researchers and healthcare professionals looking for potential new treatment options for patients with HCV.

“We are pleased to see the presentation of the final results from STARTVerso((TM) )1, 2 and 3, Boehringer Ingelheim’s pivotal Phase 3 program in our hepatitis C portfolio, as well as other important analyses evaluating various patient subgroups at this year’s AASLD meeting,” said Peter Piliero, M.D., Vice President, Clinical Development and Medical Affairs, Boehringer Ingelheim Pharmaceuticals, Inc. “These data, combined with that of our interferon-free trial, SOUND-C3, are evidence of our commitment to researching new therapeutic options for patients infected with HCV.”

Faldaprevir and deleobuvir are investigational compounds and not approved by the FDA. Their safety and efficacy have not been established.

Boehringer Ingelheim’s abstracts can be accessed on the AASLD website today at www.aasld.org.

Poster Presentations

                             Title                   Lead Author                      Presentation Details
                             -----                   -----------                      --------------------

    Effect of multiple oral doses of         J. Sabo             ID# 482

    faldaprevir on the multiple dose                             Session: HCV Therapy: The
                                                                 Developmental Pipeline
    pharmacokinetics of a combination
                                                                 Date: Sat, Nov. 2
    oral tablet of ethinylestradiol and                          Time: 2:00 PM - 7:30 PM ET
                                                                 Location: Poster Hall
    levonorgestrel in healthy

    premenopausal female volunteers
    -------------------------------

    Mass balance, metabolic profile          R. Sane             ID# 491

    and the role of hepatic and                                  Session: HCV Therapy: The
                                                                 Developmental Pipeline
    bacterial enzymes in the
                                                                 Date: Sat, Nov. 2
    metabolism of the HCV                                        Time: 2:00 PM - 7:30 PM ET
                                                                 Location: Poster Hall
    polymerase inhibitor, deleobuvir

    (BI 207127)
    ----------

    Pharmacokinetics, safety, and            F. Huang            ID# 466

    tolerability of faldaprevir in patients                      Session: HCV Therapy: The
                                                                 Developmental Pipeline
    with different levels of renal
     impairment
                                                                 Date: Sat, Nov. 2
                                                                 Time: 2:00 PM - 7:30 PM ET
                                                                 Location: Poster Hall
    ---                                                          ---------------------

    Effect of steady-state faldaprevir       D. Joseph           ID# 483

    on the pharmacokinetics of steady-state                      Session: HCV Therapy: The
                                                                 Developmental Pipeline
    methadone and buprenorphine/naloxone
                                                                 Date: Sat, Nov. 2
    in subjects on stable addiction                              Time: 2:00 PM - 7:30 PM ET
                                                                 Location: Poster Hall
    management therapy
    ------------------

    A pooled analysis of two randomized,     D. Jensen           ID# 1088

    double-blind placebo-controlled                              Session: HCV Therapeutics: New
                                                                 Agents
    Phase III trials (STARTVerso1&2) of
                                                                 Date: Sun, Nov. 3
    faldaprevir plus pegylated interferon                        Time: 8:00 AM - 5:30 PM ET
                                                                 Location: Poster Hall
    alfa-2a and ribavirin in treatment-naive

    patients with chronic hepatitis C

    genotype-1 infection
    --------------------

    Subgroup analyses and baseline           E.M. Yoshida        ID# 1114

    predictors of response with faldaprevir                      Session: HCV Therapeutics: New
                                                                 Agents
    plus pegylated interferon alfa-2a
                                                                 Date: Sun, Nov. 3
    and ribavirin in treatment-naive
     patients                                                    Time: 8:00 AM - 5:30 PM ET
                                                                 Location: Poster Hall
    with chronic hepatitis C genotype-1

    infection: a pooled analysis of

    STARTVerso1 and 2
    -----------------

    STARTVerso3: A randomized,               I. Jacobson         ID# 1100

    double-blind, placebo-controlled                             Session: HCV Therapeutics: New
                                                                 Agents
    Phase III trial of faldaprevir in
                                                                 Date: Sun, Nov. 3
    combination with pegylated interferon                        Time: 8:00 AM - 5:30 PM ET
                                                                 Location: Poster Hall
    alfa-2a and ribavirin in

    treatment-experienced patients with

    chronic hepatitis C genotype-1 infection
    ----------------------------------------

    Interferon-Free Treatment with           J.F. Dufour         ID# 1102

    Faldaprevir, Deleobuvir (BI 207127)                          Session: HCV Therapeutics: New
                                                                 Agents
    and Ribavirin in SOUND-C3: 95% SVR12
                                                                 Date: Sun, Nov. 3
    in HCV-GT1b                                                  Time: 8:00 AM - 5:30 PM ET
                                                                 Location: Poster Hall
    ---                                                          ---------------------

    STARTVerso 4 Phase III trial of          J. Rockstroh        ID# 1099

    faldaprevir plus peg interferon alfa-2a                      Session: HCV Therapeutics: New
                                                                 Agents
    and ribavirin (PR) in patients with HIV
                                                                 Date: Sun, Nov. 3
    and HCV genotype 1 coinfection:                              Time: 8:00 AM - 5:30 PM ET
                                                                 Location: Poster Hall
    end of treatment response
    -------------------------

    Pharmacokinetic interactions of          C. Cooper           ID# 1083

    Faldaprevir and Deleobuvir (BI 207127)                       Session: HCV Therapeutics: New
                                                                 Agents
    and their individual and combined effect
     on
                                                                 Date: Sun, Nov. 3
    selected cytochrome P450 (CYP) probe                         Time: 8:00 AM - 5:30 PM ET
                                                                 Location: Poster Hall
    substrates in genotype 1 hepatitis C

    infected patients
    -----------------

About Boehringer Ingelheim in Hepatitis C Virus (HCV)
In partnership with the scientific community, our clinical trial program is rigorously designed to find answers to the challenges that HCV patients face, including those who are the most difficult to treat. Our pivotal HCV clinical trials for faldaprevir and deleobuvir are comprised of two multi-trial programs, STARTVerso((TM)) and HCVerso®.

Faldaprevir, also known as BI 201335, is an investigational, oral protease inhibitor that is specifically designed to target viral replication in the liver. Boehringer Ingelheim is developing faldaprevir as a core component of both interferon-based and interferon-free hepatitis C treatment regimens. STARTVerso((TM)) is a multi-study Phase 3 trial program that evaluates faldaprevir combined with PegIFN/RBV. The four trials that make up this program study the combination in treatment-naive, treatment-experienced and HIV co-infected patients with chronic genotype-1 HCV.( )Deleobuvir, also known as BI 207127, is an investigational NS5B non-nucleoside polymerase inhibitor that has shown the potential to eliminate interferon from HCV treatment when combined in a regimen with faldaprevir and RBV. Phase 2 trials of this interferon-free regimen have been completed and Phase 3 HCVerso® trials investigating this regimen are now underway. As part of our long-term commitment to HCV, the company is exploring other combinations of investigational HCV compounds that work in complementary ways. The recent collaboration of Boehringer Ingelheim with Presidio Pharmaceuticals, Inc. for a Phase 2a clinical study investigating an interferon- and ribavirin-free, all-oral combination is part of the company’s continued commitment to discover and develop innovative options for the treatment of HCV.

STARTVerso((TM)) and HCVerso® are registered service marks of Boehringer Ingelheim International GmbH.

The Liver Meeting® is a registered trademark of the American Association for the Study of Liver Diseases (AASLD).

Hepatitis C is a blood-born infectious disease and a leading cause of chronic liver disease, transplant and failure that affects as many as 150 million people globally. In the United States, an estimated 4.1 million Americans have been infected with HCV, of which approximately 3.2 million have chronic HCV infection. Since 1999 there has been a significant increase in deaths due to chronic HCV, which accounts for 10,000-12,000 deaths in the United States per year.

About Boehringer Ingelheim
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 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.

For more information please visit www.us.boehringer-ingelheim.com.

Contact:
Boehringer Ingelheim Pharmaceuticals, Inc.

Name: Susanne Granold
Public Relations
Phone: 203-791-5851
Email: Susanne.Granold@boehringer-ingelheim.com

SOURCE Boehringer Ingelheim


Source: PR Newswire