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Media Release

Basel, 23 February 2007

Oral cancer drug Xeloda receives positive opinion from the European Authorities for the treatment of advanced gastric cancer
Stomach cancer is the second leading cause of cancer-related deaths worldwide.1

Roche announced today that its innovative oral cancer drug Xeloda (capecitabine), in combination with platinum-based chemotherapy, has received a positive recommendation from the European Committee for Medicinal Products for Human Use (CHMP) for first-line use in patients with advanced gastric (stomach) cancer.

Gastric cancer is a particularly serious form of cancer which affects twice as many men as women and occurs more frequently in people over age 55.2 Annually, there are an estimated 911,000 deaths worldwide3 with nearly 140,000 deaths in Europe alone.4 Xeloda is already licensed in South Korea for the first-line treatment of advanced stomach cancer.

"The CHMP opinion is encouraging news for European patients fighting advanced gastric cancer, a particularly aggressive and debilitating disease," said Jean-Jacques Garaud, Head of Global Pharma Development at Roche. "We look forward to receiving EU approval, another milestone in our commitment to developing effective and safe treatments for the millions of cancer patients throughout the world."

The positive recommendation is based on results from two phase III studies (ML17032 & REAL 2). The results of ML17032 confirmed that patients receiving the Xeloda/cisplatin combination lived at least as long without the cancer progressing as those treated with 5-FU/cisplatin. REAL 2, the largest - ever phase III study in advanced gastro-oesophageal cancer, demonstrated that Xeloda can replace 5-FU, and that patients treated with the combination Xeloda plus oxaliplatin and epirubicin (EOX) lived significantly longer, compared to patients treated with standard epirubicin, cisplatin and 5-FU (ECF).

"As an oral chemotherapy, Xeloda gives patients a valuable option over the current standard of intravenous treatment," said Dr Ian Chau, Gastrointestinal Unit, Department of Medicine, Royal Marsden Hospital, Sutton, UK. "Xeloda is as effective as intravenous treatment and reduces the time patients need to spend in the hospital, from five days every three weeks to only one day every three weeks, allowing patients to lead more routine lives and have more personal time. It may also potentially avoid the need of a central intravenous line with its associated inconvenience and complications."

Roche is focusing significant research efforts on Xeloda for the treatment of gastrointestinal cancers. It is already approved for first-line monotherapy of colorectal cancer that has spread (metastatic) and adjuvant (post-surgery) treatment of stage III (Duke’s stage C) colon cancer.

Study ML17032
The study, led by Professor 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 5-FU and cisplatin (FP): FP is a standard treatment of gastric 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.
  • The study confirms that Xeloda can effectively replace the old standard intravenous 5-FU, in combination with cisplatin, as first-line therapy for stomach cancer that has spread.

REAL 2 Study
The largest-ever phase III study in advanced gastro-oesophageal cancer, conducted by Professor David Cunningham and his team.

  • 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, generally 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 Commission 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 locally advanced or metastatic breast cancer (breast cancer that has spread to other parts of the body) and whose disease has progressed following at least intravenous (i.v.) chemotherapy with anthracyclines.
Xeloda monotherapy is also indicated for treatment of patients with locally advanced or metastatic breast cancer that is resistant to other chemotherapy drugs such as taxanes and anthracyclines or for whom further anthracycline therapy is not indicated.
In addition to the approval of Xeloda for first-line treatment of stomach cancer that has spread in South Korea and the CHMP positive recommendation in Europe, Roche is seeking further indications in several countries world-wide.
The most commonly reported adverse events with Xeloda include diarrhoea, abdominal pain, nausea, stomatitis and hand-foot syndrome.

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 diseases, 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 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.

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Additional information:
- Gastric and oesophageal cancer fact sheet
- Xeloda in gastric cancer fact sheet
- Roche in oncology
- Broadcast quality B-roll including doctor, caregiver and patient interviews is available for download via www.thenewsmarket.com


References:
1) Ajani, J. Evolving Chemotherapy for Advanced Gastric Cancer. The Oncologist, Oct. 2005; Vol 10, Sup. 3, 49-582.
2) Oncology Channel. www.oncologychannel.com/gastriccancer/. Visited on 15th March 2006.
3) World Health Organisation, 2005.
4) Boyle, P & Ferlay, J. Cancer incidence and mortality in Europe 2004. Annals of Oncology 2005; 16(3):481-4883.