Boehringer Ingelheim to Initiate First Phase III Pivotal Study for New Oncology Compound BIBW 2992(i)

    INGELHEIM, Germany, Sept. 6 /CNW/ -

    -   New Data on BIBW 2992(i), a Potent, Irreversible, Second-Generation
        Oral Signal Transduction Inhibitor Provides Glimpse of Next Chapter
        in Lung Cancer Care

    -   For Non-US Media

    Boehringer Ingelheim announced today from the 12th World Conference on
Lung Cancer (WCLC) that the company plans to commence Phase III pivotal trials
in lung cancer with BIBW 2992(i), its novel, second generation, potent,
irreversibly binding, dual inhibitor of EGFR and HER2 and thereby further
demonstrated its commitment to discovery and development of novel compounds in
oncology. Details of this important stage in the clinical development of BIBW
2992(i) are currently being finalised with regulatory authorities in both the
USA (FDA) and Europe (EMEA).
    This significant milestone represents an important advance for Boehringer
Ingelheim's evolving oncology portfolio and coincides with the presentation of
key data at WCLC for BIBW 2992(i).
    In a phase I study(1) by Spicer et al, evaluating the activity of BIBW
2992(i) in patients with various solid tumours, encouraging results were
obtained in patients with non-small cell lung cancer (NSCLC) with mutated
EGFR. Initial signs of clinical efficacy were observed with durable partial
responses seen in 20% of patients with NSCLC (two female and one male) with at
least two of them having deletions in EGFR exon 19 - a genetic mutation known
to be more common in females, never smokers and in patients with
adenocarcinoma. In addition, BIBW 2992(i) was found to be well tolerated at an
oral dose of 50mg daily.
    Study investigator, Dr. James Spicer, Senior Lecturer and Consultant in
Medical Oncology at King's College School of Medicine, Guy's Hospital, London,
U.K., commented on the findings: "More effective treatments for lung cancer,
with fewer side effects, are badly needed. Novel, irreversible EGFR inhibitors
like BIBW 2992(i) provide us with a glimpse of the next chapter in the
evolution of lung cancer care, as they may bridge significant gaps in existing
therapy, for example, addressing issues of resistance to treatment."
    "We also need to recognise that not all lung cancer is the same, and an
era of personalised prescribing in oncology is not far away. In particular,
patients most likely to benefit from drugs designed to hit EGFR and related
targets are female, light or never smokers, or those from East Asian
populations, a group who often have adenocarcinoma tumours with mutated EGFR,"
he added.
    Currently in phase II development, BIBW 2992(i) holds promise for
activity against tumours resistant to first-generation inhibitors, due to its
unique, irreversible dual inhibition of EGFR and HER2(2),(3), two oncogenes
associated with poor prognosis and advanced stage cancer. In studies to
date(4), BIBW 2992(i) has been shown to have effect particularly in lung
cancer patients with specific genetic mutations, reinforcing the need for
further research in this field.
    Phase I and Phase II study results from three trials in advanced NSCLC
patients were also presented at WCLC for the triple angiokinase inhibitor BIBF
1120(i), another of Boehringer Ingelheim's key oncology compounds,
simultaneously acting on vascular endothelial growth factor receptor (VEGFR),
platelet-derived growth factor receptor (PDGFR) and fibroblast growth factor
receptor (FGFR).(5)
    In both Phase I studies(6),(7), the dose for BIBF 1120(i) in combination
with pemetrexed or carboplatin/paclitaxel has been determined to be 200mg
twice daily. In all three trials, BIBF 1120(i) has been shown to be safe and
well tolerated. Furthermore, encouraging signs of efficacy have been observed
in the Phase II trial by Reck et al(8) with a considerably high rate of
disease stabilisation (48%) for all patients.
    These data, coupled with the company's commitment to enter its first
pivotal Phase III trial in oncology, mark significant progress for Boehringer
Ingelheim's evolving oncology pipeline, which currently spans three key areas:
signal transduction inhibition, angiokinase inhibition and cell cycle kinase
    Dr. Andreas Barner, Vice Chairman of the Board of Managing Directors at
Boehringer Ingelheim, said of the company's emergence into the field of
oncology "We are using advances and breakthrough science to actively develop
targeted therapies - biologicals and small molecules - in areas of unmet
medical need, with a particular interest in lung cancer. With the progress
made we have again underlined our commitment to discovering and developing
innovative cancer treatments that provide high therapeutic value for patients,
physicians and healthcare providers."
    BIBW 2992(i) and BIBF 1120(i) are the most advanced compounds in the
Boehringer Ingelheim oncology pipeline.
    To view a webcast 'The Second Generation: Revealing the Next Chapter in
the Evolution of Lung Cancer Care' which includes a presentation of this data
and related press materials, log onto:

    Please be advised

    This release is from the Corporate Headquarters of Boehringer Ingelheim
and is intended for all international markets. This being the case, please be
aware that there may be some differences between countries regarding specific
medical information including licensed uses. Please take account of this when
referring to the material.

    About the International Association for the Study of Lung Cancer

    Founded in 1972, the International Association for the Study of Lung
Cancer (IASLC) is an international organization of 2,000 lung cancer
specialists, spanning 53 countries. IASLC members work towards developing and
promoting the study of etiology, epidemiology, prevention, diagnosis,
treatment and all other aspects of lung cancer. IASLC's mission is to enhance
the understanding and education of lung cancer to scientists, members of the
medical community and the public. In addition to the biannual meeting, the
IASLC publishes the Journal of Thoracic Oncology, a prized resource for
medical specialists and scientists who focus on the detection, prevention,
diagnosis and treatment of lung cancer.

    Boehringer Ingelheim in Oncology

    Building on scientific expertise and excellence in the fields of
pulmonary and cardiovascular medicine, metabolic disease, neurology, virology
and immunology, Boehringer Ingelheim has embarked on a major research
programme to develop innovative cancer drugs, aiming to bridge therapeutic
gaps in cancer therapy. Using technological advances and breakthrough science,
Boehringer Ingelheim actively develops targeted therapies - biologicals and
small molecules - in areas of unmet medical need including both solid and
haematological cancers.
    Boehringer Ingelheim is currently focusing on three areas: Angiogenesis
Inhibition, Signal Transduction Inhibition and Cell Cycle Kinase Inhibition.
    A dedicated drug discovery facility for new cancer medicines, located in
Vienna, Austria is Boehringer Ingelheim's centre of excellence in oncology
research where more than 200 skilled and highly motivated scientists work to
discover tomorrow's cancer therapies. The heart of the oncology clinical
development is based in Boehringer Ingelheim's site in Biberach, Germany. Both
centres operate in close collaboration with independent research institutes
and experts across the globe.

    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 137 affiliates in 47 countries and 38,400 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 2006, Boehringer Ingelheim posted net sales of 10.6 billion euro while
spending one fifth of net sales in its largest business segment Prescription
Medicines on research and development.


    (i)  This compound is an investigational agent. Its efficacy and safety
         have not yet been fully established.

    (1). Spicer J et al. Activity of BIBW 2992, an oral irreversible dual
         EGFR/HER2 inhibitor, in NSCLC with mutated EGFR. Abstract D7-02.
         Presented at WCLC September 6 2007.

    (2). Solca F et al. AACR-NCI-EORTC Proceedings, AACR-NCI-EORTC
         International Conference on Molecular Targets and Cancer
         Therapeutics. 2005;118 (Abstract A244).

    (3). Solca F et al. AACR-NCI-EORTC Proceedings, AACR-NCI-EORTC
         International Conference on Molecular Targets and Cancer
         Therapeutics. 2005;118 (Abstract A242).

    (4). Data on file, Boehringer Ingelheim

    (5). Hilberg F et al. Eur J Cancer Suppl. 2004;2:50.

    (6). Hanna N et al. A Phase I study of continuous oral treatment with
         the triple angiokinase inhibitor BIBF 1120 together with pemetrexed
         in previously treated patients with NSCLC. Abstract P3-091.
         Presented at WCLC September 5, 2007.

    (7). Camidge R et al. A Phase I study of continuous oral treatment with
         the triple angiokinase inhibitor BIBF 1120 together with carboplatin
         and paclitaxel in patients with advanced NSCLC. Abstract P3-138.
         Presented at WCLC September 5 2007.

    (8). Reck M et al. Phase II double blind study to investigate efficacy
         and safety of the triple angiokinase inhibitor BIBF 1120 in patients
         suffering from relapsed, advanced NSCLC. Abstract B1-03. Presented
         at WCLC September 4 2007.

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For further information:

For further information: Julia Meyer-Kleinmann, R&D Communications,
Boehringer Ingelheim GmbH, Tel.: +49-6132-77-8271, Email:

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