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11 April 2005:
New licence approval for 'smart pill' colon cancer treatment offers solution to reduce soaring NHS waiting times and superior efficacy - with promise to save NHS over £22 million per year


Welwyn Garden City: Colon cancer patients are set to benefit from fewer visits for drug administration, fewer hospitalisations and fewer costly medications for the treatment of side effects, whilst the NHS gains from alleviating pressure on waiting times and potential cost savings of over £22 million per year as a result of today's approval by the European Medicines Agency (EMEA) for Xeloda - an innovative oral chemotherapy to be used as an adjuvant treatment (post-surgery). Adjuvant chemotherapy is one of the most common treatment regimens used in patients diagnosed with colon cancer.

"With the significant potential for Xeloda to cure more patients with early stage colon cancer than current standard treatment, and with approximately 10,000 UK patients per year eligible to receive chemotherapy after surgery, this new licence is extremely welcome," said Professor Jim Cassidy, Cancer Research UK Professor of Oncology and Chair of Medical Oncology, Beatson Oncology Centre, at the University of Glasgow. "Perhaps as important is the potential for oral Xeloda use to help achieve Government targets, reduce waiting times for treatment and deliver improvements in care for all cancer patients by taking significant strain off our cancer services as a whole."

Waiting times for treatment have are now over 6 months (201 days) for some colon cancer patients after referral from their GP, reflecting the increasing strain that is placed on cancer services. This is despite the introduction of the Government's target to reduce waiting times to a maximum of two months from urgent GP referral to treatment by the end of 2005 . When this was set out within the NHS Cancer Plan in July 20003, waiting times from GP referral to treatment were around 3 months (92 days), but have since doubled for some colon cancer patients.2 .

A reduction in waiting times can be achieved because patients treated with the oral adjuvant therapy Xeloda require 20 less visits to the chemotherapy clinic (7.4 visits versus 28.0) than patients receiving i.v. treatment. Xeloda use also demonstrates superior efficacy in reducing the risk of tumours coming back (relapse-free survival) by an impressive 14% compared to i.v. 5-FU/LV according to the X-ACT study (Xeloda in Adjuvant Colon Cancer Therapy) when compared to the current 'gold standard' adjuvant treatment. The new licence approval was granted on the strength of these major data. In addition the global study met its primary endpoint of demonstrating at least equivalent disease free survival when compared to the current 'gold standard' i.v. treatment.4

Xeloda is an oral chemotherapy pill for both advanced breast cancer and colorectal cancer. Known as a 'smart pill', Xeloda is designed to be activated and concentrated more in cancer cells than in normal cells. This results in better tolerated and more convenient treatment, as compared with current 'gold standard' i.v. chemotherapy.

Bowel cancer commands significant NHS resources as the second most common malignancy among women in the UK and the third among men. Around 34,500 patients were diagnosed with colorectal cancer in the UK in 2001 and this figure is predicted to rise to 36,500 in 2006. Colon cancer is the second biggest killing cancer in the UK after lung cancer.

About Roche
Roche is one of the world's leading research-based healthcare groups. With the aim of enhancing people's health and quality of life, our core businesses in pharmaceuticals and diagnostics provide innovative products and services for the prevention, diagnosis and treatment of disease. In the UK, Roche employs around 1,800 people in prescription and over the counter medicines and diagnostics. Visit our website at www.rocheuk.com.
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