Basel, 22 March 2005

New lung cancer medicine Tarceva receives first European approval
Swiss authority clears first and only medicine in its class that prolongs survival in advanced lung cancer

Roche’s innovative cancer drug Tarceva (erlotinib) today received approval by the Swiss health authority Swissmedic for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) after failure of at least one prior chemotherapy regimen. Tarceva is an oral tablet indicated for daily administration.

“Tarceva offers new hope to people who are suffering from this lung cancer” said William M. Burns, CEO of Roche’s Pharmaceuticals Division. “Tarceva is the first medicine in its class with a proven survival and without some of the unpleasant side effects of chemotherapy.”

Lung cancer is the most common cancer worldwide¹. There are an estimated 1.2 million new cases annually and it is reported that someone, somewhere dies of the disease every 30 seconds.² NSCLC is the most common form of lung cancer accounting for almost 80% of cases. The Swiss approval and launch also results in a certificate for free sale which is required in more than 80 other countries.

“Tarceva is a significant addition to our arsenal of treatments for patients with advanced NSCLC.” said Dr. Miklos Pless from University Hospital Basel. “There are currently very few treatment options for these patients, but we are now able to offer them the chance of extending their survival without the side effects associated with chemotherapy.”

Roche filed for approval with the Swissmedic in September 2004, with a fast track procedure granted by Swissmedic. The Swiss approval is based on data from a pivotal Phase III study which compared Tarceva to placebo for the treatment of patients with advanced NSCLC, following failure of first or second-line chemotherapy. Patients receiving Tarceva showed an increase in median survival by 42% compared to those in the placebo arm (6.7 months vs. 4.7 months), an improvement of 2 months.³ There was also a significant increase in both the length of time before patients disease symptoms deteriorated and the time when patients were stable and there was no progression of their cancer. A 45% improvement in survival at one year was observed with Tarceva, with benefits being shown in a broad spectrum of patients.

Tarceva was first approved in the United States in November 2004, after priority review, for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) after failure of at least one prior chemotherapy regimen.

About Tarceva
Tarceva is an investigational small molecule that targets the human epidermal growth factor receptor (HER1) pathway. HER1, also known as EGFR, is a key component of this signalling pathway, which plays a role in the formation and growth of numerous cancers. Tarceva blocks tumour cell growth by inhibiting the tyrosine kinase activity of the HER1 signalling pathway inside the cell.

Similarly to the significant survival benefit in NSCLC, Tarceva has also shown survival benefit in a phase III study in locally advanced or metastatic pancreatic cancer patients. The study met its primary endpoint of improving overall survival.

Tarceva is currently being evaluated in an extensive clinical development program by a global alliance among OSI Pharmaceuticals, Genentech, and Roche. Chugai is pursuing its development and regulatory approval for the Japanese market. In the United States, Tarceva is jointly marketed by Genentech and OSI Pharmaceuticals.

About Roche
Headquartered in Basel, Switzerland, Roche is one of the world’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’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 2004 sales by the Pharmaceuticals Division totalled 21.7 billion Swiss francs, while the Diagnostics Division posted sales of 7.8 billion Swiss francs. Roche employs roughly 65,000 people in 150 countries and has R&D agreements and strategic alliances with numerous partners, including majority ownership interests in Genentech and Chugai.

All trademarks used or mentioned in this release are legally protected.


Further information:
- About Roche: www.roche.com
- About Genentech: www.gene.com
- About OSI Pharmaceuticals: www.osip.com
- About cancer: www.health-kiosk.ch
- Roche in Oncology: roche.com/pages/downloads/company/pdf/mboncology05e_a.pdf


References:
1. World Health Organisation, World Cancer Report, 2003.
2. www.lungcancercoalition.org/cancer_facts.html.
3. Shepherd F, Pereira J, Ciuleanu TE, et al A randomized placebo-controlled trial of erlotinib in patients with advanced non-small cell lung cancer (NSCLC) following failure of 1st line or or 2nd line chemotherapy. A National Cancer Institute of Canada Clinical Trials Group (NCIC). (Abstract #7022), ASCO 2004.