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{\pard\sa900\fs50\f0\i Media Release\par}
{\pard\f0\li0\ri0\sa360\sl360\fs22 Basel, 22 October 2007\line \line {\b Tarceva 
approved for lung cancer in Japan} \line \line Roche, Chugai and OSI Pharmaceuticals, 
Inc. announced today that Tarceva (erlotinib) has been approved in Japan for the treatment of patients 
with nonresectable, recurrent and advanced non-small cell lung cancer (NSCLC) which is aggravated following 
chemotherapy. The Japanese Ministry of Health approval means that lung cancer patients in Japan will 
now have an important new treatment option which has been demonstrated to increase overall survival 
and offer an improvement in quality of life. \line \line Over one million people 
worldwide suffer from NSCLC. It is the most common form of lung cancer and is more deadly than colon, 
breast, and prostate cancers combined.{\super 1}  In 2005, the number of newly diagnosed 
patients with NSCLC in Japan reached 85,000.{\super 2} \line \line \u8220?Tarceva 
has proven to prolong survival and improve the quality of life of patients with the most common and 
deadly form of lung cancer,\u8221? says William M. Burns, CEO of the Pharmaceuticals Division at Roche. \u8220?This 
approval in Japan underscores our commitment to ensure that eligible patients around the world will 
have access to this effective treatment.\u8221? \line \line \u8220?This is a huge milestone 
for lung cancer patients in Japan,\u8221? said Gabriel Leung, President OSI Oncology. \u8220?The Japanese authorities 
have recognized the proven benefits of Tarceva and have acted admirably to make a significant difference 
to local patients, caregivers and oncologists battling this devastating disease.\u8221? \line \line Tarceva\u8217?s 
approval in Japan is based on the submission of two Phase II studies that confirmed the safety and efficacy 
of Tarceva in Japanese patients, along with data from the landmark, randomised, Phase III BR.21 study 
which compared Tarceva to placebo in patients with advanced NSCLC after failure of at least one prior 
chemotherapy regimen. In this study, 31% of patients receiving Tarceva were alive at one year compared 
to 22% in the placebo arm and patients experienced a 42.5% improvement (6.7 months vs. 4.7 months) in 
the length of overall survival.{\super 3}  In addition, significantly more patients 
on Tarceva had improvement in cough, pain, shortness of breath and overall physical function versus 
patients on placebo.{\super 3}  The BR.21 study, also published in the New England 
Journal of Medicine, has led to the approval of Tarceva in over 80 countries including the United States 
and the European Union for the treatment of patients with locally advanced or metastatic NSCLC after 
failure of at least one prior chemotherapy regimen. \line \line Chugai Pharmaceutical, 
Co., Ltd., a member of the Roche group, submitted the filing for this approval on April 14, 2006 to 
the Japanese Ministry of Health, Labour and Welfare. Following this formal approval, Tarceva is expected 
to launch in Japan by early 2008. \line \line {\b About Lung Cancer} \line According 
to the World Health Organisation, lung cancer is the most common cancer worldwide, with 1.2 million 
new cases annually.{\super 4}  NSCLC accounts for almost 80 percent of all lung cancer 
cases.{\super 5}  In Japan specifically, the estimated incidence of lung cancer was 
85,000 cases in 2005.{\super 2} \line \line {\b Additional 
Tarceva Information } \line Tarceva is a small molecule designed to target the human epidermal 
growth factor receptor 1 (HER1) pathway, one of the factors critical to cell growth in NSCLC and other 
solid tumors. HER1, also known as EGFR, is a 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 tumor cell growth. Tarceva 
is the only HER1/EGFR-targeted therapy proven to significantly prolong survival in second-line NSCLC 
as a single agent. \line \line Tarceva was approved by the FDA in November 2004 
and in the European Union in September 2005 as monotherapy for the treatment of patients with locally 
advanced or metastatic non-small cell lung cancer (NSCLC) after failure of at least one chemotherapy 
regimen.\line In November 2005, the U.S. Food and Drug Administration (FDA) approved the use 
of Tarceva in combination with gemcitabine for the first-line treatment of patients with locally advanced, 
unresectable or metastatic pancreatic cancer in patients who have not received previous chemotherapy. 
In January 2007, the European Commission granted marketing authorization for Tarceva in combination 
with gemcitabine for the treatment of metastatic pancreatic cancer. Tarceva is the first drug in a Phase 
III trial to have shown a significant improvement in overall survival when added to gemcitabine chemotherapy 
as an initial treatment for pancreatic cancer.\line \line For more information, 
please visit http://www.tarceva.com (http://www.tarceva.com). \line \line {\b About 
OSI} \line  
OSI Pharmaceuticals is committed to "shaping medicine and changing lives"by discovering, developing 
and commercializing high-quality and novel pharmaceutical products designed 
to extend life and/or improve the quality of life for patients with cancer and diabetes/obesity. The 
Company's oncology programs are focused on developing molecular targeted therapies designed to change 
the paradigm of cancer care. OSI's diabetes/obesity efforts are committed to the generation of novel, 
targeted therapies for the treatment of type 2 diabetes and obesity. OSI's flagship product, Tarceva 
(erlotinib), is the first drug discovered and developed by OSI to obtain FDA approval and the only EGFR 
inhibitor to have demonstrated the ability to improve survival in both non-small cell lung cancer and 
pancreatic cancer patients in certain settings. OSI markets Tarceva through partnerships with Genentech, 
Inc. in the United States and with Roche throughout the rest of the world. For additional information 
about OSI, please visit http://www.osip.com (http://www.osip.com).\line \line {\b About 
Chugai} \line Chugai Pharmaceutical, specializes in prescription pharmaceuticals and based 
in Tokyo, is Japan\u8217?s leading research-based pharmaceutical companies with strengths in biotechnology 
products.\line Since the start of the strategic alliance with Roche in October 2002, Chugai 
is actively involved in prescription pharmaceutical R&D activities in Japan and abroad as an important 
member of the Roche Group. Specifically, Chugai is working to develop innovative products with global 
applications, focusing on the disease areas of oncology, renal disease, and bone and joint.\line In 
Japan, Chugai\u8217?s research facilities in Gotemba and Kamakura are collaborating to develop new\line pharmaceuticals 
and Ukima is conducting research for technology development for industrial production. Overseas, Chugai 
Pharma USA and Chugai Pharma Europe are engaged in clinical development activities in the United States 
and Europe. Additional information is available on the Internet at www.chugai-pharm.co.jp (http://www.chugai-pharm.co.jp/hc/chugai_top_en.jsp).\line \line {\b About 
Roche} \line Headquartered in Basel, Switzerland, Roche is one of the world\u8217?s leading 
research-focused healthcare groups in the fields of pharmaceuticals and diagnostics. As the world\u8217?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\u8217?s 
health and quality of life. Roche is the world leader in in-vitro diagnostics and drugs for cancer and 
transplantation, a market leader in virology and active in other major therapeutic areas such as autoimmune 
diseases, inflammation, metabolic disorders and diseases of the 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 has R&D agreements and strategic alliances with numerous 
partners, including majority ownership interests in Genentech and Chugai, and invests approximately 
7 billion Swiss francs a year in R&D. Worldwide, the Group employs about 75,000 people. Additional 
information is available on the Internet at www.roche.com (http://www.roche.com).\line \line {\pard\f0\li0\ri0\sa360\sl360\fs18 All 
trademarks used or mentioned in this release are protected by law.\par}\line \line \line {\pard\f0\li0\ri0\sa360\sl360\fs18 References:\line 1. 
http://www.umm.edu/patiented/articles/what_lung_cancer_000072_1.htm.\line 2. A. Oshima, T. 
Kuroishi, K. Tajima, \u8220?Cancer White Paper -Incidence/Death/Prognosis \u8211? 2004.\u8221?\line 3. Shepherd 
FA, Pereira JR, Ciuleanu T, Tan EH, et al. Erlotinib in previously treated non-small-cell lung cancer. 
New England Journal of Medicine 2005; 353:123.\line 4. IARC. GLOBOCAN 2002. Cancer Incidence, 
Mortality and Prevalence Worldwide (2002 estimates). Accessed 2007 (http://www-dep.iarc.fr/).\line 5. 
Wilking N and Jonsson B. (2005) A Pan-European comparison regarding patient access to cancer drugs, 
Karolinska Institute in collaboration with Stockholm School of Economics, Stockholm, Sweden.\line \par}\par}
{\pard \par}
{\pard\sb180\f1\fs22 {\b F. Hoffmann-La Roche Ltd}\line 4070 Basel\line Switzerland \par}
{\pard\sb180\f1\fs22 Corporate Communications\line Roche Group Media Relations \par}
{\pard\sb180\f1\fs22 Tel. +41 61 688 88 88\line Fax +41 61 688 27 75\line www.roche.com \par}
}