Boehringer Ingelheim to Initiate First Phase III Pivotal Study for New Oncology Compound BIBW 2992*

Boehringer Ingelheim to Initiate First Phase III Pivotal Study for New Oncology Compound BIBW 2992*

September 06, 2007

New data on BIBW 2992*, a potent, irreversible,
second-generation oral signal transduction inhibitor
provides glimpse of next chapter in lung cancer care


    INGELHEIM, Germany, Sept. 6 /Xinhua-PRNewswire/ -- (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*, 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* 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*. 

    In a phase I study(1) by Spicer et al, evaluating the
activity of BIBW 2992* 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* 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* 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* 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* 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*, 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*
in combination with pemetrexed or carboplatin/paclitaxel
has been determined to be 200mg twice daily. In all three
trials, BIBF 1120* 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 inhibition. 

    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* and BIBF 1120* 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:
http://www.lungcancer-thenextchapter.com .

    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.

    For more information please visit
http://www.boehringer-ingelheim.com .

    References

    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.

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


    For more information, please contact:

     Julia Meyer-Kleinmann, 
     R&D Communications, 
     Boehringer Ingelheim GmbH
     Tel:   [phone]
     Email: [e-mail]