Media Release

Basel, 19 November 2004

US approval for breakthrough lung cancer medicine Tarceva
Targeted treatment significantly improves survival of patients with advanced lung cancer

Roche, OSI Pharmaceuticals and Genentech announced today that the US Food and Drug Administration (FDA) have approved Tarceva (erlotinib) 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 in the United States. Tarceva is the first and only EGFR-targeted treatment to have shown a significant survival benefit in patients with NSCLC, improving survival by 42%.

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EGFR is a key component of the human epidermal growth factor receptor pathway, which plays a role in the formation and growth of numerous cancers.

Lung cancer is the most common cancer worldwide

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with 1.2 million new cases annually; NSCLC accounts for almost 80 percent of all these cases. Lung cancer has a particularly high morbidity and every 30 seconds

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someone in the world dies of the disease. With very limited treatment options available, the FDA approval of Tarceva provides patients, with advanced disease, access to this much needed, novel anti-cancer drug.

Tarceva is also currently under review for marketing authorisation with the European and other health authorities.

"Tarceva is the first treatment of its kind to have shown an impressive survival benefit in patients with advanced cancers,” said William M. Burns, Head of Roche Pharmaceuticals Division. “The speed of which the FDA has approved Tarceva is testimony to this. We are pleased that patients in the US will now be able to benefit from this innovative treatment and we are working closely with European and other regulatory authorities to bring this treatment to other patients as quickly as possible”

The FDA approval was based on results from the pivotal Phase III randomised trial (BR.21) involving 731 patients, which compared Tarceva to placebo for the treatment of patients with advanced NSCLC, following failure of first or second-line chemotherapy. Patients receiving Tarceva lived significantly longer than those in the placebo arm (6.7 months vs 4.7 months), an improvement of 42%.

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There was also a significant increase in both the length of time before patients symptoms deteriorated and the time when patients were stable, and there was no progression of their cancer. In addition, there was a 45% improvement in survival at one year and further analysis showed treatment benefit over a broad spectrum of patients.

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.

Roche in Oncology
Within the last five years the Roche Group including its members 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 five products with survival benefit in different major tumour indications: Xeloda and Herceptin in advanced stage breast cancer, MabThera in non-Hodgkin’s lymphoma, Avastin in colorectal carcinoma and Tarceva in non-small cell lung cancer.
In the United States Herceptin, MabThera and Avastin are marketed either by Genentech alone or together with Biogen Idec Inc. (MabThera). Outside of the United States, Roche and its Japanese partner Chugai are responsible for the marketing of these medicines.

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 5.6 billion Swiss francs in the first nine months 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 research-intensive healthcare groups. Its core businesses are pharmaceuticals and diagnostics. As a supplier of innovative 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 medicines for cancer and transplantation and a market leader in virology. In 2003, the Pharmaceuticals Division generated 19.8 billion Swiss francs in prescription drug sales, while the Diagnostics Division posted sales of 7.4 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.

Reference:
1. Shepherd, F.; 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.
2. World Health Organisation, World Cancer Report, 2003.
3. www.lungcancercoalition.org/cancer_facts.html.

Further information:
- Genentech: www.gene.com
- OSI Pharmaceuticals: www.osip.com
- Cancer: www.health-kiosk.ch