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Joint 15th ECCO and 34th ESMO Multidisciplinary Congress:
Marketed Products and Pipeline Compounds Highlighted at Presentation Sessions
Berlin, September 17, 2009 - Bayer Schering Pharma today announced that data
from more than 30 clinical trials evaluating three products in the company's
oncology portfolio - Nexavar® (sorafenib) tablets, regorafenib (BAY 73-4506)
and AlpharadinTM - will be presented at the joint 15th European CanCer
Organisation (ECCO) and 34th European Society for Medical Oncology (ESMO)
Multidisciplinary Congress, September 20-24, 2009 in Berlin, Germany.
"Bayer is committed to discovering and developing innovative cancer-fighting
therapies, and as a global organization with widespread reach and impact, we
are able to apply our experience, knowledge and passion to offer treatments
that may make life better for cancer patients across the globe," said Rob
Rosen, Head of the Therapeutic Area Oncology at Bayer Schering Pharma. "While
much progress has been made in the treatment of cancer, there is still an unmet
medical need for improved therapies that may help patients manage their
disease, ultimately treating cancer as a chronic illness, rather than a
devastating disease."
Nexavar Data Highlights
Nexavar is currently approved in more than 80 countries for the treatment of
patients with hepatocellular carcinoma (HCC), or liver cancer, and in more than
90 countries for the treatment of patients with advanced renal cell carcinoma
(RCC), or kidney cancer. Even though these indications are well established,
the utility of Nexavar continues to be evaluated in these tumor types, with
ongoing studies examining special patient populations and long-term use. Data
on these indications being presented at ECCO-ESMO include results from two
Phase III studies evaluating Nexavar in HCC and six studies examining Nexavar
in RCC.
In addition to its current indications, Nexavar continues to be evaluated as a
single agent or combination treatment in a wide range of cancers, including
breast cancer, thyroid cancer, and as an adjuvant therapy for kidney cancer and
liver cancer. Data from a recently unblinded Phase II trial evaluating the
safety and efficacy of Nexavar as a potential treatment for breast cancer will
be presented during an oral session at ECCO-ESMO. This trial examined Nexavar
compared to placebo in combination with the oral chemotherapeutic agent,
capecitabine, in patients with locally advanced or metastatic breast cancer.
(Late-breaking presentation 3LBA, Presidential Session III, Wednesday,
September 23, 1:30 p.m., Hall 1)
Additionally, data from a completed Phase II study of single-agent Nexavar in
patients with thyroid cancer will be presented at the congress (Late-breaking
poster 51LBA, Poster 276, Tuesday, September 22, 9:00 a.m.-5:00 p.m. Hall 14.1)
Nexavar is being co-developed by Bayer HealthCare AG and Onyx Pharmaceuticals,
Inc.
Regorafenib Data Highlights
A promising development compound in the oncology portfolio pipeline is
regorafenib (BAY 73-4506), a potent oral multi-kinase inhibitor with a kinase
inhibition profile targeting angiogenic, stromal and oncogenic receptor
tyrosine kinases (TK). The anti-angiogenic activity found with regorafenib
treatment is due to its unique dual targeted VEGFR2-TIE2 TK inhibition.
Regorafenib is currently being studied as a potential treatment option in
multiple tumor types. Updated results from a Phase II trial of regorafenib in
patients with RCC will be presented at ECCO-ESMO during an oral session.
(Abstract 7105, Tuesday, September 22, 10:15 a.m. CET)
Alpharadin Data Highlights
Bayer Schering Pharma AG, Germany, recently entered into a global agreement
with Algeta ASA, Oslo, Norway for the development and commercialization of
Alpharadin, a novel alpha-emitting radiopharmaceutical, based on radium-223.
Alpharadin is currently being evaluated in a global Phase III trial for the
treatment of bone metastases in symptomatic hormone-refractory prostate cancer
(HRPC) patients. Three Phase II trials evaluating the safety and efficacy of
Alpharadin will be presented at ECCO-ESMO, including an oral presentation on
the results from a 122-patient efficacy and safety study designed to compare
the prostate cancer specific antigen (PSA) response rate of three different
repeat doses of Alpharadin. (Abstract 7003, Monday, 21 September, 11:45 a.m.
CET, Hall 3)
About Nexavar®
Nexavar targets both the tumor cell and tumor vasculature. In preclinical
studies, Nexavar has been shown to target members of two classes of kinases
known to be involved in both cell proliferation (growth) and angiogenesis
(blood supply) - two important processes that enable cancer growth. These
kinases included Raf kinase, VEGFR-1, VEGFR-2, VEGFR-3, PDGFR-B, KIT, FLT-3 and
RET.
Nexavar is currently approved in more than 80 countries for the treatment of
patients with liver cancer and in more than 90 countries for the treatment of
patients with advanced kidney cancer. Nexavar is also being evaluated by Bayer
and Onyx, international study groups, government agencies and individual
investigators as a single agent or combination treatment in a wide range of
cancers, including breast cancer, colorectal cancer, lung cancer, ovarian
cancer, and as an adjuvant therapy for kidney cancer and liver cancer.
About Regorafenib (BAY 73-4506)
Regorafenib (BAY 73-4506) is a potent oral multi-kinase inhibitor with a kinase
inhibition profile targeting angiogenic, stromal and oncogenic receptor
tyrosine kinases (TK). The anti-angiogenic activity found with Regorafenib
treatment is due to its distinct dual targeted VEGFR2-TIE2 TK inhibition.
Regorafenib has also been shown in preclinical studies to prevent the
proliferation of tumor cell lines while promoting apoptosis (cell death) by
directly targeting several oncogenic TK receptors. The clinical significance of
these studies is not known and warrant further investigation in a broad
spectrum of tumors.
About AlpharadinTM
AlpharadinTM (radium-223 chloride) represents a first in class opportunity of
cancer therapy based on alpha-radiation, offering highly targeted treatment of
bone metastases by delivering radiation directly to the tumor cells with low
exposure to the surrounding tissue. Alpharadin is being co-developed between
Bayer Schering Pharma and Algeta ASA. While Alpharadin is currently being
evaluated in a global Phase III trial in patients with HRPC and skeletal
metastases, the companies see potential in investigating Alpharadin for the
treatment of bone metastases from other tumor types.
About Bayer Schering Pharma
The Bayer Group is a global enterprise with core competencies in the fields of
health care, nutrition and high-tech materials. Bayer HealthCare, a subsidiary
of Bayer AG, is one of the world's leading, innovative companies in the
healthcare and medical products industry and is based in Leverkusen, Germany.
The company combines the global activities of the Animal Health, Bayer Schering
Pharma, Consumer Care and Medical Care divisions. Bayer HealthCare's aim is to
discover and manufacture products that will improve human and animal health
worldwide. Find more information at www.bayerhealthcare.com.
Bayer Schering Pharma is a worldwide leading specialty pharmaceutical company.
Its research and business activities are focused on the following areas:
Diagnostic Imaging, General Medicine, Specialty Medicine and Women's
Healthcare. With innovative products, Bayer Schering Pharma aims for leading
positions in specialized markets worldwide. Using new ideas, Bayer Schering
Pharma aims to make a contribution to medical progress and strives to improve
the quality of life. Find more information at www.bayerscheringpharma.de.
