Bayer HealthCare to present its clinical trial data at a joint Multidisciplinary Congress

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.

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