Boehringer Ingelheim to initiate first Phase III pivotal study for new oncology compound BIBW 2982

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 study1 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.

Lead 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: “While we continue to strive for a ‘cancer cure’ the quest to develop more advanced treatment options with improved patient outcomes goes on. Novel, irreversibly binding agents 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 treatments addressing issues such as treatment resistance, as well as providing hope for those lung cancer patients with specific genetic mutations including those who have never smoked and patients particularly from East Asian populations.”

Currently in phase II development, BIBW 2992 holds promise for activity against tumours resistant to first-generation inhibitors, due to its irreversible dual inhibition of EGFR and HER22,3, two oncogenes associated with poor prognosis and advanced stage cancer. In studies to date4, 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 studies6,7, 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 al8 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.

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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.

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

Additional information:

Boehringer Ingelheim Austria GmbH
Dr. Boehringer-Gasse 5 – 11 A-1121 Vienna Tel. +43-(0)1-801 05-0 Fax +43-(0)1-804 08 23 Mag. Inge Homolka Communication Tel. DW 2230 Mag. Monika Primenz Communication Tel. DW 2742

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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