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

Ingelheim, Germany (ots/PRNewswire) -

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

- For Non-US Media

Boehringer Ingelheim announced today from the 12th WorldConference on Lung Cancer (WCLC) that the company plans to commencePhase III pivotal trials in lung cancer with BIBW 2992(i), its novel,second generation, potent, irreversibly binding, dual inhibitor ofEGFR and HER2 and thereby further demonstrated its commitment todiscovery and development of novel compounds in oncology. Details ofthis important stage in the clinical development of BIBW 2992(i) arecurrently being finalised with regulatory authorities in both the USA(FDA) and Europe (EMEA).

This significant milestone represents an important advance forBoehringer Ingelheim's evolving oncology portfolio and coincides withthe presentation of key data at WCLC for BIBW 2992(i).

In a phase I study(1) by Spicer et al, evaluating the activity ofBIBW 2992(i) in patients with various solid tumours, encouragingresults were obtained in patients with non-small cell lung cancer(NSCLC) with mutated EGFR. Initial signs of clinical efficacy wereobserved with durable partial responses seen in 20% of patients withNSCLC (two female and one male) with at least two of them havingdeletions in EGFR exon 19 - a genetic mutation known to be morecommon in females, never smokers and in patients with adenocarcinoma.In addition, BIBW 2992(i) was found to be well tolerated at an oraldose of 50mg daily.

Study investigator, Dr. James Spicer, Senior Lecturer andConsultant in Medical Oncology at King's College School of Medicine,Guy's Hospital, London, U.K., commented on the findings: "Moreeffective treatments for lung cancer, with fewer side effects, arebadly needed. Novel, irreversible EGFR inhibitors like BIBW 2992(i)provide us with a glimpse of the next chapter in the evolution oflung cancer care, as they may bridge significant gaps in existingtherapy, 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 tohit EGFR and related targets are female, light or never smokers, orthose from East Asian populations, a group who often haveadenocarcinoma tumours with mutated EGFR," he added.

Currently in phase II development, BIBW 2992(i) holds promise foractivity against tumours resistant to first-generation inhibitors,due to its unique, irreversible dual inhibition of EGFR andHER2(2),(3), two oncogenes associated with poor prognosis andadvanced stage cancer. In studies to date(4), BIBW 2992(i) has beenshown to have effect particularly in lung cancer patients withspecific genetic mutations, reinforcing the need for further researchin this field.

Phase I and Phase II study results from three trials in advancedNSCLC patients were also presented at WCLC for the triple angiokinaseinhibitor BIBF 1120(i), another of Boehringer Ingelheim's keyoncology compounds, simultaneously acting on vascular endothelialgrowth factor receptor (VEGFR), platelet-derived growth factorreceptor (PDGFR) and fibroblast growth factor receptor (FGFR).(5)

In both Phase I studies(6),(7), the dose for BIBF 1120(i) incombination with pemetrexed or carboplatin/paclitaxel has beendetermined 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 IItrial by Reck et al(8) with a considerably high rate of diseasestabilisation (48%) for all patients.

These data, coupled with the company's commitment to enter itsfirst pivotal Phase III trial in oncology, mark significant progressfor Boehringer Ingelheim's evolving oncology pipeline, whichcurrently spans three key areas: signal transduction inhibition,angiokinase inhibition and cell cycle kinase inhibition.

Dr. Andreas Barner, Vice Chairman of the Board of ManagingDirectors at Boehringer Ingelheim, said of the company's emergenceinto the field of oncology "We are using advances and breakthroughscience to actively develop targeted therapies - biologicals andsmall molecules - in areas of unmet medical need, with a particularinterest in lung cancer. With the progress made we have againunderlined our commitment to discovering and developing innovativecancer treatments that provide high therapeutic value for patients,physicians and healthcare providers."

BIBW 2992(i) and BIBF 1120(i) are the most advanced compounds inthe Boehringer Ingelheim oncology pipeline.

To view a webcast 'The Second Generation: Revealing the NextChapter in the Evolution of Lung Cancer Care' which includes apresentation 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 BoehringerIngelheim and is intended for all international markets. This beingthe case, please be aware that there may be some differences betweencountries regarding specific medical information including licenseduses. 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 ofLung Cancer (IASLC) is an international organization of 2,000 lungcancer specialists, spanning 53 countries. IASLC members work towardsdeveloping and promoting the study of etiology, epidemiology,prevention, diagnosis, treatment and all other aspects of lungcancer. IASLC's mission is to enhance the understanding and educationof lung cancer to scientists, members of the medical community andthe public. In addition to the biannual meeting, the IASLC publishesthe Journal of Thoracic Oncology, a prized resource for medicalspecialists 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 ofpulmonary and cardiovascular medicine, metabolic disease, neurology,virology and immunology, Boehringer Ingelheim has embarked on a majorresearch programme to develop innovative cancer drugs, aiming tobridge therapeutic gaps in cancer therapy. Using technologicaladvances and breakthrough science, Boehringer Ingelheim activelydevelops targeted therapies - biologicals and small molecules - inareas of unmet medical need including both solid and haematologicalcancers.

Boehringer Ingelheim is currently focusing on three areas:Angiogenesis Inhibition, Signal Transduction Inhibition and CellCycle Kinase Inhibition.

A dedicated drug discovery facility for new cancer medicines,located in Vienna, Austria is Boehringer Ingelheim's centre ofexcellence in oncology research where more than 200 skilled andhighly motivated scientists work to discover tomorrow's cancertherapies. The heart of the oncology clinical development is based inBoehringer Ingelheim's site in Biberach, Germany. Both centresoperate in close collaboration with independent research institutesand experts across the globe.

About Boehringer Ingelheim

The Boehringer Ingelheim group is one of the world's 20 leadingpharmaceutical companies. Headquartered in Ingelheim, Germany, itoperates globally with 137 affiliates in 47 countries and 38,400employees. Since it was founded in 1885, the family-owned company hasbeen committed to researching, developing, manufacturing andmarketing novel products of high therapeutic value for human andveterinary medicine.

In 2006, Boehringer Ingelheim posted net sales of 10.6 billioneuro while spending one fifth of net sales in its largest businesssegment Prescription Medicines on research and development.


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

(1). Spicer J et al. Activity of BIBW 2992, an oral irreversibledual 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-EORTCInternational Conference on Molecular Targets and CancerTherapeutics. 2005;118 (Abstract A244).

(3). Solca F et al. AACR-NCI-EORTC Proceedings, AACR-NCI-EORTCInternational Conference on Molecular Targets and CancerTherapeutics. 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 treatmentwith the triple angiokinase inhibitor BIBF 1120 together withpemetrexed in previously treated patients with NSCLC. AbstractP3-091. Presented at WCLC September 5 2007.

(7). Camidge R et al. A Phase I study of continuous oral treatmentwith the triple angiokinase inhibitor BIBF 1120 together withcarboplatin and paclitaxel in patients with advanced NSCLC. AbstractP3-138. Presented at WCLC September 5 2007.

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

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

ots Originaltext: Boehringer IngelheimIm Internet recherchierbar: http://www.presseportal.de

Contact:Contact: Julia Meyer-Kleinmann, R&D Communications, Boehringer Ingelheim GmbH, Tel.: +49-6132-77-8271, Email: M-Kleinmann@boehringer-ingelheim.com

Boehringer Ingelheim

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