{\rtf1\ansi\ansicpg1252\cocoartf949\cocoasubrtf430
{\fonttbl\f0\froman\fcharset0 TimesNewRomanPSMT;\f1\fswiss\fcharset0 ArialMT;}
{\margl1800\margr1600\margt500\margbl1440}
{\pard\sa900\fs50\f0\i Media Release\par}
{\pard\f0\li0\ri0\sa360\sl360\fs22 Basel, 23 February 2007\line \line {\b Recruitment 
temporarily 
suspended into C.E.R.A. Phase II oncology trial} \line \line Roche 
announced today that it is temporarily suspending recruitment into its Phase II dose-finding study (NH19960) 
with the investigational drug C.E.R.A. in anaemic patients with advanced non small cell lung cancer 
receiving chemotherapy. An independent Drug Safety Monitoring Board (DSMB) involved in the study recommended 
this course of action which Roche\u8217?s Drug Safety Committee endorsed yesterday. Treatment of enrolled 
patients will continue.\line This action has been taken because of a numerical imbalance in 
the number of deaths across the four arms of the study (three arms with C.E.R.A. and one arm with darbepoetin 
alfa) driven in part by deaths reported to be due to the progression of the underlying cancer (Stage 
IIIb and IV Non Small Cell Lung Cancer patients receiving first line chemotherapy).\line \line The 
investigators reported all deaths to be unrelated to the study drugs. There appears to be no association 
of these events to excessive haemoglobin (Hb) levels or the administered doses based on the current 
review of the data. \line \line Roche has not observed a similar type of imbalance 
in previously completed studies (one phase I/II and two phase II studies) with C.E.R.A. in cancer patients 
receiving chemotherapy. In another ongoing Clinical Pharmacology Study for lung cancer in Japan, there 
have been no reported deaths during the scheduled clinical trial period.\line \line A 
review of the patient data also shows that there were imbalances upon entry into the trial between the 
different arms in categories like the severity of tumour spread, presence of liver metastases and incidence 
of chronic obstructive pulmonary disease (COPD).\line 153 patients have been randomized on 
the study. Patients who are already enrolled will continue with the study as planned. The safety data 
from the patients continuing in the study will be closely monitored by Roche working with the DSMB. 
Roche is further investigating the potential causes for the imbalance across the arms in this population 
of severely ill patients with advanced and rapidly progressing disease who were enrolled in the study. 
\line Suspending recruitment and allowing currently enrolled patients to complete the 12-week 
study period will permit an in-depth analysis of the data to determine potential confounding factors 
and potentially allow recruitment to be restarted.\line \line Roche has informed 
all investigators involved in the study of its decision and is working closely with them. The company 
has also informed Health Authorities in the countries where the study is taking place. Roche is committed 
to patient safety and to the development of innovative medicines that meet unmet medical needs. \line \line {\b About 
the study} \line This is a multicenter, randomized, open label dose finding study of C.E.R.A. 
in anaemic patients with stage IIIB or IV non-small cell lung cancer receiving first line chemotherapy.\line This 
study is assessing the optimal starting dose of C.E.R.A. in the treatment of anaemia in patients with 
non-small cell lung cancer receiving first line chemotherapy. Patients are randomized to receive C.E.R.A. 
6.3\u181?g/kg, 9\u181?g/kg or 12\u181?g/kg s.c. every 3 weeks or darbepoetin alfa according to the approved local label 
(either 6.75\u181?g/kg s.c. every 3 weeks, or 2.25\u181?g/kg every week). \line Please go to the Roche 
Clinical Trial Registry at www.roche-trials.com/patient/trials/trial110602.html (http://www.roche-trials.com/patient/trials/trial110602.html) 
for further information.\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 diseases, 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 drugs for cancer and transplantation and a market leader in 
virology. In 2006 sales by the Pharmaceuticals Division totalled 33.3 billion Swiss francs, and the 
Diagnostics Division posted sales of 8.7 billion Swiss francs. Roche employs roughly 75,000 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 at 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 protected by law.\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}
}
