November 26, 2013

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    26 November 2013

  • Accelerated assessment reserved for medicinal products of major interest from the viewpoint of public health and therapeutic innovation1
  • Submission based on comprehensive development programme including the Phase III STARTVerso™ data aiming to demonstrate the efficacy and safety of faldaprevir* + PegIFN/RBV in a broad range of genotype-1 infected hepatitis C patients2,3,4

    For media outside of the U.S.A., UK and Canada only

    INGELHEIM, 26 November, 2013 – The application for European marketing authorisation of faldaprevir*, a potent second generation oral protease inhibitor, has been fully validated and granted accelerated assessment by the European Medicines Agency (EMA).5,6 Boehringer Ingelheim is seeking marketing approval of faldaprevir* in combination with pegylated interferon and ribavirin (PegIFN/RBV) for the treatment of a broad range of patients with genotype-1 (GT-1) hepatitis C, including difficult-to-cure populations such as those with HIV co-infection or advanced liver disease.

    "Faldaprevir* has been studied with pegylated interferon and ribavirin in a broad range of more than 3,300 patients typical of those that doctors see in every day clinical practice. Faldaprevir* has demonstrated strong efficacy and a robust safety profile while also offering the convenience of once-daily dosing and no food restrictions," said Professor Klaus Dugi, Corporate Senior Vice President Medicine at Boehringer Ingelheim. "The acceptance for accelerated assessment by the EMA supports our position that if approved, faldaprevir* will provide an important alternative to currently available hepatitis C treatments."

    Accelerated assessment status does not automatically lead to a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) or the granting of a marketing authorization by the European Commission.1 If approved by the European Commission, faldaprevir* could be available for marketing in the EU in the second half of 2014.

    The EMA Marketing Authorisation Application is based on a comprehensive clinical development programme for faldaprevir* with a particular focus on the Phase III STARTVerso™ trial data, recently presented at the 64th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD). These studies include data for faldaprevir* in:

    • Treatment naïve patients with the majority having benefited from shorter treatment duration and achieved viral cure2
    • Difficult-to-cure patient populations such as those with HIV co-infection4 or advanced liver disease2,3
    • Patients with the Q80K polymorphism (this mutation is considered to affect the efficacy of other second generation protease inhibitors)2
    • Treatment experienced patients who have relapsed,  partially responded or failed to respond to previous therapy3

    For full results see the STARTVerso™ press release here.

    Faldaprevir* is the foundation of Boehringer Ingelheim’s hepatitis C treatment pipeline and is being developed in combinations both with and without interferon. In addition to the interferon-based faldaprevir* regimen that has been submitted for marketing approval, Boehringer Ingelheim aims to deliver one of the first interferon-free regimens for the treatment of hepatitis C infection. The goal is to make an interferon-free future a reality for a broad range of hepatitis C patients. Pivotal Phase III HCVerso® data for the interferon-free regimen of faldaprevir*, deleobuvir* and ribavirin will be available in 2014.

    NOTES TO EDITORS

    The Boehringer Ingelheim NewsHome: An innovative resource for journalists
    The Boehringer Ingelheim hepatitis C www.newshome.com is the one-stop-shop for clear, concise and easy to understand information about hepatitis C for media.

    About Boehringer Ingelheim in hepatitis C
    Through pioneering science, Boehringer Ingelheim is striving to find answers to the pressing challenges still faced by the diverse population of hepatitis C patients. The company’s comprehensively designed hepatitis C clinical trial programme includes a broad range of patients including those with the most challenging types of hepatitis C to cure that clinicians see every day in clinical practice.

    Boehringer Ingelheim is developing faldaprevir*, an investigational second generation protease inhibitor, in combinations both with and without interferon.
    Interferon-based therapy with faldaprevir* has the potential to improve cure rates with the added convenience of once-daily dosing and no food restrictions.  In clinical trials, faldaprevir* has shown efficacy in a broad range of genotype-1a and 1b hepatitis C patients. The Phase III STARTVerso™ trial programme, which includes treatment-naïve, treatment-experienced and HIV co-infected patients with hepatitis C virus, is nearly complete.

    Deleobuvir* is a potent investigational non-nucleoside NS5B polymerase inhibitor used in combination with faldaprevir and ribavirin for the treatment of patients with genotype-1b hepatitis C virus. The Phase III HCVerso® trials, investigating this interferon-free regimen are well underway.

    As part of Boehringer Ingelheim’s long-term commitment to hepatitis C, the company is also evaluating other combinations of investigational hepatitis C compounds that work in different ways. Boehringer Ingelheim’s recent collaboration with Presidio Pharmaceuticals, Inc. for a Phase II clinical study investigating an interferon-free, all-oral, potentially ribavirin-free combination is part of the company’s continued exploration to discover and develop innovative options for the treatment of hepatitis C.

    About Hepatitis C
    Hepatitis C is a blood-borne infectious disease caused by the hepatitis C virus which lives and replicates in the liver. Hepatitis C is a leading cause of chronic liver disease, liver cancer and transplantation.7 Chronic hepatitis C is a major public health issue and one of the most prevalent infectious diseases worldwide, affecting around 170 million people,8 with 3-4 million new cases occurring each year.9

    It is common for hepatitis C patients to remain undiagnosed due to the initial unspecific symptoms of the disease. Consequently, a large number of patients first present to their physician when they experience symptoms or already have liver disease.10 Patients with advanced liver disease are challenging to cure, yet have the greatest need for more effective and better tolerated treatments.

    Of patients with chronic hepatitis C, 20 percent will develop liver cirrhosis, of which 2-5 percent will die every year.11 Advanced liver disease due to hepatitis C currently represents the main cause for liver transplantation in the western world.11

    About Boehringer Ingelheim
    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.

    In 2012, Boehringer Ingelheim achieved net sales of about 14.7 billion euro. R&D expenditure in the business area Prescription Medicines corresponds to 22.5% of its net sales.

    * Faldaprevir and deleobuvir are investigational compounds and not yet approved. Their safety and efficacy have not yet been fully established.

    References

    1European Medicines Agency Committee for Medicinal Products for Human Use (CHMP) Guideline on the procedure for accelerated assessment pursuant to article 14 (9) of regulation (EC) No 726/2004
    2Jensen, D. et al. A pooled analysis of two randomized, double-blind placebo-controlled Phase III    trials (STARTVerso1&2) of faldaprevir plus pegylated interferon alfa-2a and ribavirin in treatment- naïve patients with chronic hepatitis C genotype-1 infection. Presented at The Liver Meeting®, the  64th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD),1 – 5 November, 2013
    3Jacobson, I. et al. STARTVerso3: A randomized, double-blind, placebo-controlled Phase III trial of faldaprevir in combination with pegylated interferon alfa-2a and ribavirin in treatment-experienced patients with chronic hepatitis C genotype-1 infection. Presented at The Liver Meeting®, the 64th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD),1 – 5 November, 2013
    4Rockstroh, J. et al.  STARTVerso 4 Phase III trial of faldaprevir plus peg interferon alfa-2a and ribavirin (PR) in patients with HIV and HCV genotype 1 co-infection: end of treatment response. Presented at The Liver Meeting®, the 64th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD),1 – 5 November, 2013
    5Boehringer Ingelheim Data on file. European Medicines Agency, Human Medicines Evaluation Division. (Faldaprevir Boehringer Ingelheim, Boehringer Ingelheim International GmbH). Submission validation, 21 November, 2013
    6Boehringer Ingelheim Data on file. European Medicines Agency, Human Medicines Evaluation Division. (Faldaprevir Boehringer Ingelheim, Boehringer Ingelheim International GmbH). Accelerated assessment acceptance, 12 November, 2013
    7World Health Organisation. Hepatitis C. 2002 http://www.who.int/csr/disease/hepatitis/Hepc.pdf [Last accessed on 21/10/13]
    8Centers for Disease Control and Prevention (2012) Hepatitis C available at: http://wwwnc.cdc.gov/travel/yellowbook/2012/chapter-3-infectious-diseases-related-to-travel/hepatitis-c.htm [Last accessed on 21/10/13]
    9World Health Organisation. Hepatitis C Fact Sheet. Updated July 2012 http://www.who.int/mediacentre/factsheets/fs164/en/index.html [Last accessed on 21/10/13]
    10Chen S.L., Morgan T.R. The Natural History of Hepatitis C Virus (HCV) Infection. Int J Med Sci 2006; 3:47-52. Available from http://www.medsci.org/v03p0047.htm [Last accessed on 21/10/13]
    11Soriano, Vincent et al. New Therapies for Hepatitis C Virus Infection. Clinical Infectious Disease, February 2009

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