Media Release

Basel, 20 September 2004

Significant Survival Benefit for Breakthrough Drug Tarceva in Advanced Pancreatic Cancer
Study shows a significant improvement in overall survival for patients given Tarceva combined with chemotherapy versus chemotherapy alone

Roche, Genentech, Inc. and OSI Pharmaceuticals, Inc., today announced positive results from a phase III study of investigational drug Tarceva (erlotinib) in locally advanced or metastatic pancreatic cancer patients. The study met its primary endpoint of improving overall survival.

This study demonstrated a statistically significant 23.5 percent improvement in overall survival for patients with locally advanced or metastatic pancreatic cancer receiving Tarceva plus gemcitabine, when compared to patients receiving gemcitabine alone (a hazard ratio of 0.81 and a p-value of 0.025 were observed). A statistically significant improvement in progression-free survival was also demonstrated although no differences in tumour response were observed.

Pancreatic cancer is the fourth leading cause of all cancer deaths; in Europe each year 60,000 people are diagnosed with pancreatic cancer and current treatment options are limited.

“The survival benefit delivered in this study is particularly exciting, as these results come on top of the good data in lung cancer. This means new hope for pancreatic patients who currently have a poor prognosis and further encourages us that Tarceva may have significant potential in a number of cancers,” said William M. Burns, Head of Roche’s Pharmaceuticals Division. “This study reaffirms Tarceva’s position as the fifth product in our oncology portfolio with a proven survival benefit alongside Herceptin, MabThera, Xeloda and Avastin, underlining Roche’s leadership in oncology.”

“The results of this trial of Tarceva in combination with gemcitabine represent an important advancement in treating patients with pancreatic cancer,” stated Dr. Malcolm Moore, Study Chair and Medical Oncologist at Princess Margaret Hospital and Chair of the Gastrointestinal Disease Site, NCIC Clinical Trials Group. “Pancreatic cancer is widely recognized as a difficult disease to treat and new therapeutic regimens are desperately needed. These results also demonstrate that the HER1/EGFR signalling pathway is an important target in pancreatic cancer, and offer hope that further progress can be made.”

In a recent study, Tarceva was shown to significantly improve survival in non-small cell lung cancer (NSCLC), the most common type of cancer worldwide. A Marketing Authorisation Application for Tarceva monotherapy treatment of advanced non-small cell lung cancer was recently made to the European health authorities and to the US Food and Drug Administration (FDA). Early-stage trials of Tarceva are also being conducted in other solid tumours, such as ovarian, colorectal, head and neck, renal cell carcinoma, glioma and gastrointestinal cancers.

About the Study
The multi-centre, randomised, double-blind, placebo-controlled Phase III international study was conducted by the National Cancer Institute of Canada, Clinical Trials Group at Queens University (NCIC CTG) in collaboration with OSI Pharmaceuticals. The study evaluated Tarceva at 100mg/day or 150mg/day in patients with locally advanced or metastatic pancreatic cancer. Patients received either gemcitabine with Tarceva or gemcitabine plus placebo. A total of 569 patients were randomised into the study, with 521 patients receiving 100mg/day Tarceva or placebo and 48 patients receiving 150mg/day Tarceva or placebo. The study was an international study with sites in the U.S., Asia, Canada, Europe, Australia and South America.

This international study demonstrated a statistically significant 23.5 percent improvement in overall survival for patients with locally advanced or metastatic pancreatic cancer when compared with overall survival in patients receiving gemcitabine plus placebo. A hazard ratio of 0.81 and a p-value of 0.025 were observed (a hazard ratio of less than one indicates a reduction in the risk of death and a p-value of less than 0.05 indicates statistical significance). A statistically significant improvement in progression-free survival was also demonstrated although no differences in tumour response were observed. A preliminary analysis of the safety data did not reveal any unexpected safety signal beyond that seen in prior experience of Tarceva use in both monotherapy and combination settings.

About Tarceva
Tarceva is a small molecule designed to target the human epidermal growth factor receptor 1 (HER1) pathway, which is one of the factors critical to cell growth in many cancers. HER1, also known as EGFR, is a key component of the HER signalling pathway, which plays a role in the formation and growth of numerous cancers. Tarceva is designed to inhibit the tyrosine kinase activity of the HER1 signalling pathway inside the cell, which may block tumour cell growth. Previous studies have shown that Tarceva is the first agent to show a survival benefit in patients with relapsed non-small cell lung cancer, resulting in Roche’s recent submission of a Marketing Authorisation Application to the European health authorities for Tarceva for the monotherapy treatment of advanced non-small cell lung cancer. A similar application for Tarceva has also been made to the U.S. Food and Drug Administration.

About Pancreatic Cancer
The pancreas is a large organ lying behind the stomach that is essential in the metabolism of sugar and fat. Cancer of the pancreas strikes about 5 out of every 100,000 people and is one of the deadliest forms of cancer. Approximately 60,000 new cases of pancreatic cancer are diagnosed per year in Europe and 30,000 new cases in the US. The prognosis is poor for pancreatic cancer patients, with most studies showing 5-year survival of less than 5%. Those at the highest risk are in their 60s to 80s. Most pancreatic tumours originate in the cells of the pancreas that produce digestive enzymes (acinar cells). These adenocarcinomas account for almost 95% of pancreatic tumours.

About Roche in Oncology
Within the last five years the Roche Group including its partners Genentech in the US and Chugai in Japan has become the world’s leading provider of anti-cancer treatments, supportive care products and diagnostics. Its oncology business includes an unprecedented four marketed products with survival benefit in different major tumour indications: Xeloda and Herceptin in advanced stage breast cancer, MabThera in non-Hodgkin’s lymphoma, and Avastin in colorectal carcinoma. In the United States Herceptin, MabThera and Avastin are marketed either by Genentech alone or together with Biogen Idec Inc. Outside of the United States, Roche and its Japanese partner Chugai are responsible for the marketing of these drugs.

The Roche oncology portfolio also includes NeoRecormon (anaemia in various cancer settings), Bondronat (prevention of skeletal events in breast cancer and bone metastases patients, hypercalcaemia of malignancy), Kytril (chemotherapy and radiotherapy-induced nausea and vomiting) and Roferon-A (hairy cell and chronic myeloid leukaemia, Kaposi's sarcoma, malignant melanoma, renal cell carcinoma). CERA is the most recent demonstration of the commitment to anaemia management. The Roche Group’s cancer medicines generated sales of more than 3.3 billion Swiss francs in the first half of 2004.

Roche is developing new tests, which will have a significant impact on disease management for cancer patients in the future. With a broad portfolio of tumour markers for prostate, colorectal, liver, ovarian, breast, stomach, pancreas and lung cancer, as well as a range of molecular oncology tests, we will continue to be the leaders in providing cancer focused treatments and diagnostics.

Roche Oncology has four research sites (two in the US, Germany and Japan) and four Headquarter Development sites (two in the US, UK and Switzerland).

About Roche
Headquartered in Basel, Switzerland, Roche is one of the world’s leading innovation-driven healthcare groups. Its core businesses are pharmaceuticals and diagnostics. As a supplier of products and services for the prevention, diagnosis and treatment of disease, the Group contributes on a broad range of fronts to improving people’s health and quality of life. Roche is number one in the global diagnostics market, the leading supplier of pharmaceuticals for cancer and transplantation and a market leader in virology. In 2003 prescription drug sales by the Pharmaceuticals Division totalled 19.8 billion Swiss francs, while the Diagnostics Division posted sales of 7.4 billion Swiss francs. Roche employs roughly 65,000 people in 150 countries and has alliances and R&D agreements with numerous partners, including majority ownership interests in Genentech and Chugai.

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