Media Release

Basel, 30. March 2007

Xeloda approved in Europe for the treatment of advanced stomach cancer
New effective oral treatment option also reduces time in hospital by 80%

The European Commission approved Xeloda in combination with platinum-based chemotherapy, for first-line use in patients with advanced stomach cancer. Oral chemotherapy Xeloda is already replacing standard intravenous (i.v.) therapy 5-fluorouracil (5-FU) in other gastrointestinal cancers, and now for the first time patients with advanced stomach cancer will also benefit from this effective and convenient treatment option.

William M. Burns, CEO Roche Pharma Division, said: "The news from the European Commission is welcome by both patients and physicians. Stomach cancer is a particularly aggressive and debilitating type of cancer and with Xeloda, Roche can provide an effective oral therapy resulting in a cost effective approach with less hospital visits and more flexibility for the patient".

Stomach cancer is the fourth most commonly diagnosed cancer and the second leading cause of cancer-related deaths worldwide¹. Annually, there are an estimated 911,000 deaths worldwide², with nearly 140,000 deaths in Europe alone³.

"Not only is capecitabine as effective and safe as intravenous treatment but it also reduces the time patients need to spend in hospital by 80%, from five days every three weeks to only one day every three weeks." said Professor Y.K. Kang of the Asan Medical Center, Seoul, South Korea. "Up to now, the standard treatment has involved using intravenous pumps which the patients find inconvenient and uncomfortable. As an oral drug, capecitabine can be taken in the comfort of your own home, making it much more convenient. The clinical community welcomes this news as we now have a new option for our patients"

The approval of Xeloda in combination with platinum-based chemotherapy (with or without epirubicin), was based on two trials, called ML17032 and REAL 2.  Both these trials showed that patients on the Xeloda-containing arms lived at least as long overall as those on the 5-FU arms.  In fact, the REAL 2 study showed patients on one of the Xeloda-containing arms (EOX) lived significantly longer than the reference 5-FU arm (ECF).

Xeloda on its own is already available in other gastrointestinal cancers, including colorectal cancer that has spread and post-surgery colon cancer.  Recently, Xeloda has been filed in the USA for first and second line treatment (with or without Avastin) of advanced colorectal cancer. Additional filings of Xeloda and Avastin combination therapy are planned in the near future. In addition, Roche is running a large Phase III program in early stage colon cancer, which includes Xeloda in combination with oxaliplatin (XELOX) with or without Avastin.

About Study ML17032
The study, led by Professor Y K Kang and his team, is a large randomised, open-label, international phase III study in advanced stomach cancer.  
It was conducted in 316 patients enrolled in 46 centres across 13 countries in Asia, South America and Europe.  
The study compared the efficacy and safety of Xeloda and cisplatin (XP) with intravenous (i.v.) 5-FU and cisplatin (FP): FP is a standard treatment of stomach cancer, and is accepted by the majority of regulatory agencies as one of the reference regimens against which all other regimens should be compared.
The primary end point was non-inferiority in progression-free survival.
Patients receiving the XP combination therapy lived at least as long without the cancer progressing as those treated with FP.
Patients on XP also lived at least as long overall as those on FP, showing evidence of non inferiority.
The study confirms that Xeloda can effectively replace the old standard i.v. 5-FU, in combination with cisplatin, as first-line therapy for advanced stomach cancer.

About REAL 2 Study
The largest-ever phase III study in advanced gastro-oesophageal cancer.
It was conducted in 1002 advanced gastro-oesophageal cancer patients from 61 centres mainly in the UK.
The study aimed to establish the potential use of Xeloda (X) and oxaliplatin (O) in untreated patients.
Patients were randomised to one of four regimens: epirubicin, cisplatin and 5-FU (ECF), epirubicin, oxaliplatin and 5-FU (EOF), epirubicin, cisplatin and Xeloda (ECX) or epirubicin, oxaliplatin and Xeloda (EOX).
The primary comparison was overall survival between the Xeloda and 5-FU containing arms (ECX + EOX versus ECF + EOF) and the oxaliplatin and cisplatin containing arms (EOF + EOX versus ECF + ECX).  A further comparison was survival between all four regimens.
The study showed that Xeloda was as effective as 5-FU and could replace 5-FU.
The study showed that patients treated with the combination of Xeloda plus oxaliplatin and epirubicin (EOX) live significantly longer, compared to patients treated with standard epirubicin, cisplatin and 5-FU (ECF).

About Xeloda
Xeloda is licensed in more than 90 countries worldwide including the EU, USA, Japan, Australia and Canada and has been shown to be an effective, safe, simple and convenient oral chemotherapy in treating over 1 million patients to date.

Roche received marketing authorisation for Xeloda as a first-line monotherapy (by itself) in the treatment of metastatic colorectal cancer (colorectal cancer that has spread to other parts of the body) in most countries (including the EU and USA) in 2001.  Xeloda has also been approved by the European Medicines Agency (EMEA) and U.S. Food and Drug Administration (FDA) for adjuvant (post-surgery) treatment of colon cancer in March and June 2005, respectively.

Xeloda is licensed in combination with Taxotere (docetaxel) in women with metastatic breast cancer (breast cancer that has spread to other parts of the body) and whose disease has progressed following i.v. chemotherapy with anthracyclines.  Xeloda monotherapy is also indicated for treatment of patients with metastatic breast cancer that is resistant to other chemotherapy drugs such as paclitaxel and anthracyclines.  Xeloda recently received approval in South Korea for the first-line treatment of patients with locally advanced (metastatic) pancreatic cancer, in combination with gemcitabine.  
Xeloda is licensed in South Korea for the first-line treatment of stomach cancer.

The most commonly reported adverse events with Xeloda include diarrhoea, abdominal pain, nausea, stomatitis and hand-foot syndrome (palmar-plantar erythrodysesthaesia).

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 the world’s biggest biotech company and an innovator of 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’s health and quality of life. Roche is the world leader in diagnostics and drugs for cancer and transplantation, a market leader in virology and active in other major therapeutic areas such as autoimmune diseases, inflammation, metabolism and central nervous system. 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 worldwide 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.

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References:
1) Ajani, J. Evolving Chemotherapy for Advanced Gastric Cancer. The Oncologist, Oct. 2005; Vol. 10, Sup. 3, 49-582
2) World Health Organisation, 2005.
3) Boyle, P & Ferlay, J. Cancer incidence and mortality in Europe 2004. Annals of Oncology 2005; 16(3):481-4883.