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{\pard\sa900\fs50\f0\i Media Release\par}
{\pard\f0\li0\ri0\sa360\sl360\fs22 Basel, 13 February 2006\line \line {\b Recruitment 
temporarily 
suspended in an international phase III trial (AVANT) in post-surgical adjuvant colon cancer}  \line Patients 
within this study continue treatment and the broad Roche-Genentech Oncology programme remains on track\line \line \line Roche 
announced today that safety data from AVANT, a trial to study different combination treatments for post-surgical 
adjuvant colon cancer, will be further reviewed.\line \line The review has been 
recommended by the AVANT independent Data Safety Monitoring Board (DSMB) and is supported by Roche. 
The DSMB\u8217?s recommendation is based on two reasons: a safety concern observed in one of the three study 
arms and the fast recruitment in the AVANT trial (more than 200 patients per month) which could prevent 
adequate and timely intervention. To enable the DSMB to undertake a review of 60-day safety data the 
recruitment of additional patients will be temporarily halted. Patients already enrolled into the AVANT 
trial will continue treatment as per the study protocol. The safety data from these patients will continue 
to be closely monitored by the DSMB. All ongoing Roche studies in the oncology area will continue as 
planned.\line \line Professor Aimery de Gramont, Principal Investigator for AVANT 
stated: \u8220?The AVANT trial provides a unique opportunity to assess the effect of combining an anti-angiogenic 
agent with standard chemotherapy in the adjuvant colon cancer setting. The temporary halting of the 
recruitment is necessary because in the adjuvant setting, the threshold for concern is particularly 
low. However, we look forward to exciting findings that will hopefully confirm the efficacy benefits 
that we have already observed in the metastatic setting. This will open the avenue for new options for 
patients suffering from colon cancer\u8221? \line \line Since the AVANT trial began recruitment 
in December 2004, almost two third of the target number of 3,450 patients have been enrolled and in 
January 2006 alone, more than 250 patients were recruited. The all cause mortality excluding deaths 
due to the recurrent colon cancer in the AVANT trial for FOLFOX-4 (Arm A) was 0.6% (4 cases), for FOLFOX-4 
+ Avastin (Arm B) 0.4% (3 cases) and for XELOX + Avastin (Arm C) 1% (7 cases). These rates are consistent 
with those reported in other adjuvant studies in colon cancer. An occurrence of sudden deaths (4), especially 
in three younger patients was noted in Arm C. Temporarily suspending recruitment will allow the DSMB 
to perform a full safety assessment. The DSMB will continue to monitor all adverse events in the study, 
including gastrointestinal perforations, a side effect observed in previous studies of Avastin plus 
chemotherapy, that has been observed in the AVANT study at a rate of 1%. This is less than what has 
been observed in the metastatic setting (up to 2%). \line \line \u8220?We concur with 
the DSMB\u8217?s recommendation,\u8221? Ed Holdener, Head of Global Development at Roche said. \u8220?Patient safety is 
of utmost importance to us. Speed of recruitment in the AVANT trial is exceeding expectations and safety 
should be carefully monitored, especially in the adjuvant setting where the risk/benefit profile is 
different from that of the metastatic setting. As such, we are committed to continuous monitoring and 
evaluation of all safety data reported from the AVANT trial. Roche has an unprecedented clinical trial 
programme in place in Oncology.\u8221?\line \line A second study of Avastin plus chemotherapy 
as an adjuvant treatment for early-stage colon cancer, called C-08, is continuing recruitment as scheduled. 
Conducted primarily in the U.S by the National Surgical Breast and Bowel Project (NSABP) in collaboration 
with the National Cancer Institute (NCI), C-08 will enroll 2,714 patients. Patients are being randomized 
into two arms:\par}{\pard\f0\li440\ri0\sl360\fs22 - Arm 1: FOLFOX (control arm)\par}{\pard\f0\li440\ri0\sl360\fs22 - Arm 
2: FOLFOX+Avastin (experimental 
arm)\par}\line {\pard\f0\li0\ri0\sa360\sl360\fs22 Like the AVANT study, the NSABP\u8217?s C-08 trial has 
an independent 
DSMB that reviews safety data on a regular basis. This study has enrolled more than 1,800 patients since 
the trial opened in 2004 and the DSMB has not made any changes to the study protocol.\line \line Avastin 
was approved in February 2004 in the USA and in the EU in January 2005 for the treatment of patients 
with previously untreated metastatic colorectal cancer (mCRC) and has a well-established efficacy and 
safety profile demonstrated through its use in over 54,000 patients worldwide. \line \line There 
are currently more than 9,000 patients taking part in Avastin clinical trials across several indications. 
At this time, the DSMB\u8217?s recommendation for AVANT does not affect ongoing and planned studies of Avastin 
in colorectal cancer or in other tumour types.\line \line {\b About AVANT} \line The 
AVANT trial is a 3-arm global study (308 centers from 33 countries) randomizing high-risk stage II and 
stage III patients with colon cancer to FOLFOX-4 (infused/bolus 5-FU/LV + oxaliplatin), FOLFOX-4 plus 
Avastin, or XELOX (capecitabine + oxaliplatin) plus Avastin (arms A, B and C respectively). The objectives 
of AVANT are to assess whether adding Avastin to the chemotherapy regimens FOLFOX-4 or XELOX can prolong 
disease-free survival (i.e. whether it can reduce the chance of the cancer recurring) in patients who 
had no evidence of macroscopic disease after curative surgery and to determine the safety profile of 
Avastin when used Avastin in combination with FOLFOX-4 or XELOX in the adjuvant setting. \line \line {\b About 
Avastin} \line Avastin is the first treatment that inhibits angiogenesis \u8211? the growth 
of a network 
of blood vessels that supply nutrients and oxygen to cancerous tissues. Avastin targets a naturally 
occurring protein called VEGF (Vascular Endothelial Growth Factor), a key mediator of angiogenesis, 
thus choking off the blood supply that is essential for the growth of the tumour and its spread throughout 
the body (metastasis).\line \line In Europe, Avastin is approved for first-line 
treatment of patients with metastatic carcinoma of the colon or rectum in combination with the chemotherapy 
regimens of intravenous 5-fluorouracil/folinic acid or intravenous 5-fluorouracil/folinic acid/irinotecan. 
Avastin received fast-track approval by the US Food and Drug Administration (FDA) and was launched in 
the US in February 2004.\line \line In the pivotal Phase III study, the addition 
of Avastin to chemotherapy (irinotecan/5-fluorouracil/leucovorin) significantly extended survival by, 
on average, five months (20.3 months versus 15.6 months) for people with previously untreated metastatic 
colorectal cancer. Avastin also significantly increased the amount of time the cancer was not growing 
compared with patients receiving chemotherapy alone (10.6 months vs. 6.2 months). In a second Phase 
III study, conducted by the Eastern Cooperative Oncology Group (ECOG), Avastin was also shown to significantly 
improve survival when added to another widely prescribed chemotherapy regimen (oxaliplatin/5-fluorouracil/leucovorin). 
With Avastin, people who had previously failed one chemotherapy regimen for their advanced disease, 
lived nearly two months longer, on average, compared to those who received chemotherapy alone (12.5 
months vs. 10.7 months).\line \line People with very advanced colorectal cancer 
who are too unwell to tolerate traditional aggressive chemotherapy also benefit from Avastin. The addition 
of Avastin to a less aggressive form of chemotherapy increased the length of time the cancer was not 
growing, by four months, compared to chemotherapy alone (a 67 percent increase in progression-free survival).\line \line Roche 
and Genentech are pursuing a comprehensive clinical programme investigating the use of Avastin in advanced 
colorectal cancer with other chemotherapies and also expanding into the adjuvant setting (post operation). 
As its mechanism may be relevant in a number of malignant tumours, Roche and Genentech are also investigating 
the potential clinical benefit of Avastin in breast, lung, pancreatic cancer, ovarian cancer, renal 
cell carcinoma and others. Approximately 15,000 patients are expected to be enrolled into clinical trials 
over the next years worldwide.\line \line {\b About Safety of Avastin} \line The 
safety profile of Avastin in metastatic colorectal cancer has been defined in the first line treatment 
(e.g. pivotal trial AVF2107 {\super 1} ,) and second-line treatment (E3200 trial {\super 2} ,) 
settings through a large phase 
III programme where Avastin was tested in combination with 5-FU, irinotecan and oxaliplatin containing 
regimens. In general, Avastin appears to be well tolerated. The most common adverse effects observed 
in clinical trials of metastatic colorectal cancer that are attributable to Avastin therapy are: hypertension, 
proteinuria, arterial thrombosis, wound healing complications and bleeding. Rare cases (up to 2%) of 
GI perforations have also been observed. While higher incidences of these events were reported in patients 
receiving Avastin than in control patients, most of these adverse effects were manageable.\line \line These 
safety findings have been confirmed with a US registry (BRITE) and a global Expanded Access Programme 
(FIRST BEAT) which include a total of almost 4,000 patients treated with Avastin. \line \line {\b About 
Safety of Xeloda} \line The safety profile of Xeloda in metastatic colorectal cancer has 
been 
defined in the first line treament (SO14695 and SO14796 {\super 3} ) and adjuvant colon 
cancer (M66001 X-ACT 
{\super 4} ). In general, Xeloda appears to be well tolerated. The most common adverse 
effects observed in 
clinical trials of metastatic colorectal cancer and adjuvant colon cancer that are attributable to Xeloda 
therapy are: diarrhea, nausea, vomiting, stomatitis and hand-foot syndrome. The safety data from the 
NO16968 XELOXA study in adjuvant colon cancer show that the combination Xeloda plus oxaliplatin (XELOX) 
combination appears to be well tolerated {\super 5} .\line \line The 
safety data from 
the ongoing study in 1st line mCRC, NO16966 comparing XELOX+Avastin/placebo with FOLFOX+Avastin/placebo 
in a 2x2 factorial design have been continuously monitored by a DSMB and no safety signals leading to 
modification of the trial have been idenfied.\line \line {\b About Roche} \line Headquartered 
in Basel, Switzerland, Roche is one of the world\u8217?s leading research-focused healthcare groups in the 
fields of pharmaceuticals and diagnostics. As a supplier of innovative products and services for the 
early detection, prevention, diagnosis and treatment of disease, the Group contributes on a broad range 
of fronts to improving people\u8217?s health and quality of life. Roche is a world leader in diagnostics, 
the leading supplier of medicines for cancer and transplantation and a market leader in virology. In 
2005 sales by the Pharmaceuticals Division totalled 27.3 billion Swiss francs, and the Diagnostics Division 
posted sales of 8.2 billion Swiss francs. Roche employs roughly 70,000 people in 150 countries and has 
R&D agreements and strategic alliances with numerous partners, including majority ownership interests 
in Genentech and Chugai. Additional information about the Roche Group is available on the Internet (www.roche.com (http://www.roche.com)).\line \line {\pard\f0\li0\ri0\sa360\sl360\fs18 All 
trademarks used or mentioned in this release are legally protected.\par}\line \line  
{\pard\f0\li0\ri0\sa360\sl360\fs18 1 The pivotal trial AVF2107 compared IFL with or without AVASTIN in first line treatment 
of patients 
with metastatic colorectal cancer.\line 2 E3200 investigated AVASTIN in combination with 
FOLFOX-4 in patients with relapsed metastatic colorectal cancer whose disease progressed following previous 
treatment with both a 5-FU and irinotecan based chemotherapy regimen, either alone or in combination.\line  
3 SO14695 and SO14796, two trials with identical design comparing Xeloda with bolus 5-FU/LV in first 
line treatment of patients with metastatic colorectal cancer.\line 4 M66001 X-ACT comparing 
Xeloda with bolus 5-FU/LV in adjuvant treatment of patients with stage III colon cancer.\line  
5 NO16968 XELOXA comparing Xeloda+oxaliplatin(XELOX) with bolus 5-FU/LV in adjuvant treatment of 
patients with stage III colon cancer\par}\line \par}
{\pard \par}
{\pard\sb180\f1\fs22 {\b F. Hoffmann-La Roche Ltd}\line 4070 Basel\line Switzerland \par}
{\pard\sb180\f1\fs22 Corporate Communications\line Roche Group Media Relations \par}
{\pard\sb180\f1\fs22 Tel. +41 61 688 88 88\line Fax +41 61 688 27 75\line www.roche.com \par}
}