NEXAVAR(R) approved for the treatment of HCC in more than 70 countries as a result of Canadian-led trial
TORONTO, Nov. 17 /CNW/ - Bayer Inc. announced today that its international trial known as SHARP (Sorafenib HCC Assessment Randomized Protocol), led by Study Manager and Bayer Canada employee Tom Giannaris, has been selected as the winner in the 'Best International Trial' category for the Global Clinical Practice Journal Awards. The positive results of the SHARP trial have, to date, led to the approval of NEXAVAR(R) (sorafenib) in more than 70 countries for the treatment of liver cancer and have represented a significant advancement in the disease by providing patients with a much-needed treatment option.
"This is an outstanding achievement for Bayer and for our Canadian operation to be recognized for our commitment to research and leadership in providing innovative solutions for patients," said Shurjeel Choudhri, Head, Medical and Scientific Affairs, Bayer Inc. "In Canada, we are particularly proud to have had Tom Giannaris lead this highly successful international trial. The success of SHARP has opened the door to additional trials on hepatocellular carcinoma (HCC) so we can continue to provide advancements in this area of oncology."
Canada was one of 21 participating countries in the SHARP trial and contributed six research centres in Toronto, Montreal, Calgary, Edmonton, Winnipeg and Ottawa. Results of the SHARP Trial were published in the New England Journal of Medicine in July 2008. Based in Toronto, Manager of Study Management, Tom Giannaris, oversaw the International SHARP trial from start to finish and says the results were tremendously gratifying.
"Participating in the SHARP trial was certainly a career highlight for myself and the entire study team," said Tom Giannaris. "The exceptional quality of the SHARP trial, together with its timely completion, is testimony to the team's hard work and focus. It is very satisfying to know the results have given hope to patients who had few, if any, options before."
This marks the second year in a row Bayer has received an award from the Global Clinical Practice Journal Awards, having won last year for 'The Most Successful Global Trial' for the BETASERON(R) BEYOND study in multiple sclerosis.
About the Global Clinical Practice Journal (GCPj) Awards
The Clinical Research Excellence Awards, from the publishers of the Global Clinical Practice journal (GCPj), were developed to recognize excellence in the clinical trials industry. Now in its third year, the Awards honour and reward corporate and individual excellence and celebrate innovation throughout the industry.
About Liver Cancer
Hepatocellular carcinoma (HCC) is the most common form of liver cancer and is responsible for approximately 90 per cent of the primary malignant liver tumours in adults.(1),(2) It is the fifth most common cancer in the world(3) and the third leading cause of cancer-related deaths globally.(4) Liver cancer is more prevalent in men than women, with 1,040 new diagnoses in men, compared to 310 in women.(5) It is estimated that 1,700 new cases of liver cancer will be diagnosed in Canada in 2009.(6)
NEXAVAR(R) (sorafenib tablets) is indicated for the treatment of patients with unresectable hepatocellular carcinoma (HCC) and for the treatment of locally advanced/metastatic renal cell (clear cell) carcinoma (RCC) in patients who failed or are intolerant to prior systemic therapy.
NEXAVAR(R) targets both the tumour cell and tumour vasculature and is the only oral multi-kinase inhibitor that does not require liver cancer patients to interrupt their treatment schedule. In preclinical studies, NEXAVAR(R) has been shown to target members of two classes of kinases (or proteins) known to be involved in both cell proliferation (growth) and angiogenesis (growth of new blood vessels) - two important processes that enable cancer growth. NEXAVAR(R) works by slowing tumour growth and by cutting off the blood supply to the tumour (angiogenesis). NEXAVAR(R) acts on proteins which include RAF kinase, VEGFR-2, VEGFR-3, PDGFR-beta, KIT, FLT-3 and RET.
The safety and effectiveness of NEXAVAR(R) in pediatric patients has not been established. NEXAVAR(R) is contraindicated for patients who are hypersensitive to this drug or to any ingredient in the formulation or component of the container. For a complete listing of ingredients, see the Product Monograph.
NEXAVAR(R) is currently approved in more than 70 countries for liver cancer and in more than 80 countries for the treatment of patients with advanced kidney cancer.
About Bayer Inc.
Bayer Inc. (Bayer) is a Canadian subsidiary of Bayer AG, an international research-based group with core businesses in health care, crop science and innovative materials. Headquartered in Toronto, Ontario, Bayer Inc. operates the Bayer Group's HealthCare and MaterialScience businesses in Canada. Bayer Crop Science Inc., headquartered in Calgary, Alberta operates as a separate legal entity in Canada. Together, the companies play a vital role in improving the quality of life for Canadians - producing products that fight diseases, protecting crops and animals, and developing high-performance materials for applications in numerous areas of daily life. Canadian Bayer facilities include the Toronto headquarters and offices in Montréal and Calgary.
Bayer Inc. has approximately 900 employees across Canada and had sales of $908 million CDN in 2008. Globally, the Bayer Group had sales of over 32 billion Euro in 2008. Bayer Inc. invested approximately $36 million CDN in research and development in 2008. Worldwide, the Bayer Group spent the equivalent of over 2.6 billion Euro in 2008 in R&D. For more information, go to www.bayer.ca.
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 website 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.
(1) World Health Organization/Hepatitis B. Web site.
Accessed January 15, 2008.
(2) Penn State Milton S. Hershey Medical Center College of
Medicine/Malignant Hepatoma. Web site.
January 15, 2008.
(3) World Health Organization. Estimates by WHO Region: Incidence. Web
s. Accessed January 15, 2008.
(4) World Health Organization/Cancer Fact Sheet Number 297. Web site.
Accessed January 15, 2008.
(5) Canadian Cancer Society. Canadian Cancer Encyclopedia. Web site:
Accessed January 9, 2008.
(6) Canadian Cancer Society. Canadian Cancer Encyclopedia. Web site:
Accessed on November 5, 2009
SOURCE Bayer Inc.
For further information: For further information: Laura Burns, Senior Business Communications Partner, Bayer Inc., (416) 240-5466, email@example.com