Bayer's NEXAVAR approved in over 70 countries for the treatment of liver cancer

BAYER INC.Nov 17 2009

NEXAVAR(R) approved for the treatment of HCC in more than 70 countries as a result of Canadian-led trial

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.