Investor Update

Basel, 12 December 2009

New Phase II study showed trastuzumab-DM1 shrank tumours in women with highly advanced HER2-positive breast cancer

T-DM1, an Investigational Antibody-Drug Conjugate, Showed Encouraging Results in Women Who Have Received Multiple Prior Medicines

Roche (SIX: RO, ROG; OTCQX: RHHBY), today announced positive results from a Phase II study of trastuzumab-DM1 (T-DM1).  As assessed by independent review, T-DM1 shrank the tumors (also known as objective response) in 33 percent of women with advanced (metastatic) HER2-positive breast cancer that had worsened following previous treatment.  Women in the study had already received an average of seven drugs for metastatic disease, including chemotherapy, trastuzumab and lapatinib, prior to receiving T-DM1.  No new or unexpected safety signals were observed. Results were presented today at the 32nd Annual San Antonio Breast Cancer Symposium (Abstract #710).

“Despite major advances in HER2-positive breast cancer, the disease may still progress even after several treatments, to the point where there are no approved anti-HER2 medicines,” said Hal Barron, M.D., executive vice president, Global Development, and chief medical officer, Genentech.  “Results from this study are promising for women who need new treatment options, and we will discuss next steps of the T-DM1 development program with the FDA.”

In this single-arm study, 45 percent of women experienced a clinical benefit (defined as a complete or partial tumour response, or stable disease, maintained for at least six months), as assessed by independent review.  Adverse events were similar to those observed in previous clinical trials of T-DM1.  The most common severe adverse events included thrombocytopenia (a low level of platelets in the blood, 5.5 percent) and back pain (3.6 percent), and the most common adverse events were fatigue (59.1 percent) and nausea (37.3 percent).

About the Study (TDM4374g)

The Phase II study (known as TDM4374g) is a single-arm, multi-center trial designed to assess T-DM1 as a single agent in 110 women with HER2-positive advanced breast cancer whose disease had progressed after receiving at least two prior HER2-targeted treatments  (trastuzumab and lapatinib) in the metastatic setting, as well as an anthracycline, a taxane, and capecitabine. The primary endpoint of the study is objective response rate (a complete or partial tumor shrinkage of at least 30 percent, determined by two tumor assessments at least 28 days apart), as measured by an independent review facility.

Secondary endpoints include safety, clinical benefit rate, duration of response and progression-free survival (PFS).  Duration of response and PFS data are not yet mature, and will be presented at a future meeting.

About T-DM1

T-DM1 is a novel, antibody-drug conjugate (ADC) in development for HER2-positive advanced breast cancer.  ADCs are a unique combination of a precise and targeted monoclonal antibody, a stable linker, and a potent cytotoxic.  T-DM1 combines two approaches in one medicine: the anti-cancer activity of the trastuzumab antibody, which blocks signals that make the cancer more aggressive and signals the body’s immune system to destroy the cancerous cells, and the targeted delivery of the potent cytotoxic DM1.  This year, Genentech and Roche initiated a Phase III study (EMILIA) evaluating T-DM1 in women with advanced HER2-positive breast cancer whose disease has progressed after receiving initial treatment.

About breast cancer

Breast cancer is the most common cancer among women worldwide.¹ Each year more than one million new cases of breast cancer are diagnosed worldwide, and nearly 400,000 people will die of the disease annually.²

In HER2-positive breast cancer, increased quantities of the HER2 protein are present on the surface of the tumour cells. This is known as ‘HER2-positivity’ and affects approximately 20-25% of women with breast cancer.

About Roche

Headquartered in Basel, Switzerland, Roche is a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics. Roche is the world’s largest biotech company with truly differentiated medicines in oncology, virology, inflammation, metabolism and CNS. Roche is also the world leader in in-vitro diagnostics, tissue-based cancer diagnostics and a pioneer in diabetes management. Roche’s personalised healthcare strategy aims at providing medicines and diagnostic tools that enable tangible improvements in the health, quality of life and survival of patients. In 2008, Roche had over 80,000 employees worldwide and invested almost 9 billion Swiss francs in R&D. The Group posted sales of 45.6 billion Swiss francs. Genentech, United States, is a wholly owned member of the Roche Group. Roche has a majority stake in Chugai Pharmaceutical, Japan. For more information: www.roche.com.

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References
1) World Health Organization, http://www.who.int/cancer/detection/breastcancer/en/
2) Ferlay J, et al., GLOBOCAN 2002. Cancer Incidence, Mortality and Prevalence Worldwide. IARC CancerBase No.5, Version 2.0. IARCPress, Lyon, 2004. 2004