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Bayer Announces New Data on Oncology Portfolio To Be Presented at the ECCO-ESMO Congress 2009
Date:9/16/2009

BERLIN, Sept. 17 /PRNewswire/ -- Bayer HealthCare today announced that data from more than 30 clinical trials evaluating three products in the company's oncology portfolio - Nexavar(R) (sorafenib) tablets, regorafenib (BAY 73-4506) and Alpharadin(TM) - 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 HealthCare. "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. CET, 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. CET, Hall 14.1)

Nexavar is being co-developed by Bayer HealthCare Pharmaceuticals Inc. 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 is due to its distinct 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, Hall 15.1)

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, September 21, 11:45 a.m. CET, Hall 3)

Nexavar's Differentiated Mechanism

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 the companies, 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.

Important Safety Considerations For Patients Taking Nexavar

Based on the currently approved U.S. package insert for the treatment of patients with unresectable hepatocellular carcinoma and advanced kidney cancer, hypertension may occur early in the course of therapy and blood pressure should be monitored weekly during the first six weeks of therapy and treated as needed. In HCC patients, bleeding with a fatal outcome from any site was reported in 2.4% for Nexavar and 4% in placebo. The incidence of treatment-emergent cardiac ischemia/infarction was 2.7% for Nexavar vs. 1.3% for placebo. In RCC patients, incidence of bleeding regardless of causality was 15% for Nexavar vs. 8% for placebo and the incidence of treatment-emergent cardiac ischemia/infarction was 2.9% for Nexavar vs. 0.4% for placebo. Most common adverse events 20% related to Nexavar for both HCC and RCC were fatigue, weight loss, rash/desquamation, hand-foot skin reaction, alopecia, diarrhea, nausea, and abdominal pain. Grade 3/4 adverse events in HCC and RCC patients, respectively, were 45% for Nexavar vs. 32% for placebo and 38% for Nexavar and 28% for placebo. Women of child-bearing potential should be advised to avoid becoming pregnant and advised against breast-feeding. In cases of any severe or persistent side effects, temporary treatment interruption, dose modification or permanent discontinuation should be considered.

For information about Nexavar including U.S. Nexavar prescribing information, visit www.nexavar.com or call 1.866.NEXAVAR (1.866.639.2827).

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 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 Alpharadin

Alpharadin (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 HealthCare Pharmaceuticals Inc.

Bayer HealthCare Pharmaceuticals Inc. is the U.S.-based pharmaceuticals unit of Bayer HealthCare LLC, a division of Bayer AG. One of the world's leading, innovative companies in the healthcare and medical products industry, Bayer HealthCare combines the global activities of the Animal Health, Consumer Care, Diabetes Care, and Pharmaceuticals divisions. In the U.S., Bayer HealthCare Pharmaceuticals comprises the following business units: Women's Healthcare, Diagnostic Imaging, Specialized Therapeutics, Hematology/Cardiology and Oncology. The company's aim is to discover and manufacture products that will improve human health worldwide by diagnosing, preventing and treating diseases.

About Onyx Pharmaceuticals, Inc.

Onyx Pharmaceuticals, Inc. is a biopharmaceutical company committed to improving the lives of people with cancer. The company, in collaboration with Bayer HealthCare Pharmaceuticals, Inc., is developing and marketing Nexavar((R)) (sorafenib) tablets, a small molecule drug. For more information about Onyx, visit the company's website at www.onyx-pharm.com.

Forward Looking Statements

This news release may contain forward-looking statements based on current assumptions and forecasts made by Bayer Group or subgroup management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer's public reports which are available on the Bayer Web site at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

Nexavar((R)) (sorafenib) tablets is a registered trademark of Bayer HealthCare Pharmaceuticals Inc.


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SOURCE Bayer HealthCare
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