Roche skin cancer treatment Zelboraf approved for reimbursement in Switzerland

Basel, 02 April 2012

Switzerland’s first and only personalised melanoma medicine for patients suffering from the most aggressive form of skin cancer.

As of 1 April 2012 the Federal Office of Public Health (BAG) has granted the skin cancer medicine Zelboraf positive reimbursement status, adding it to the official list of medicines eligible for reimbursement in Switzerland. Zelboraf, the first and only approved personalised treatment in Switzerland shown to prolong survival in melanoma patients, underscores Roche’s leading position in personalised healthcare.

“This decision gives severely ill patients in Switzerland access to a highly effective medicine,” said Manfred Heinzer, General Manager of Roche Pharma (Switzerland) Ltd. “Zelboraf represents a milestone in the treatment of metastatic melanoma. This personalised medicine offers patients effective treatment for the most aggressive form of skin cancer. Swissmedic approved the medicine in record time.”

Zelboraf is an oral medicine that inhibits the uncontrolled growth of cancer cells that express certain mutated forms of the BRAF protein. Such mutations are found in about half of all melanoma patients. The mutations can be detected using the cobas 4800 BRAF V600 Test, which Roche developed simultaneously with the medicine. As a result, Zelboraf can be targeted specifically at patients with such mutations and are therefore likely to benefit from treatment. Roche’s BRAF test has been available in Switzerland since the third quarter of 2011.

Professor Reinhard Dummer of University Hospital Zurich, who headed one of the two major studies that were pivotal in securing approval, commented: “Zelboraf is something completely new. It is the first medicine ever to specifically target melanoma cells. We have been doing trials involving melanoma and other skin tumours for over 20 years, and we have never seen results like these.”

If melanoma is diagnosed early, it is generally a curable disease. However, once secondary tumours have formed in other parts of the body, it becomes fatal and is the most aggressive form of skin cancer. People with metastatic melanoma have a short life expectancy, typically measured in months. In registration trials Zelboraf was the only medicine to significantly prolong survival in both previously untreated and previously treated patients with advanced melanoma. Interim analysis of data from the phase III BRIM3  study, for example, showed a 63 percent reduction in the risk of death for patients receiving Zelboraf compared with those on standard first-line treatment. In addition, a post-hoc analysis of BRIM3 data covering a longer follow-up period than earlier analyses showed that Zelboraf significantly prolonged survival compared with standard first-line therapy.

About Zelboraf

The US Food and Drug Administration (FDA) approved Zelboraf for BRAF V600 mutation-positive inoperable or metastatic melanoma in 2011, simultaneously with the cobas 4800 BRAF V600 Mutation Test. Zelboraf has also recently been approved in Europe, Brazil, Israel, Canada and New Zealand. Approval is currently pending in Australia, India and other countries worldwide. While Roche seeks regulatory approval of Zelboraf in other countries, a global safety study is providing access to Zelboraf for over 2000 people with previously treated or untreated BRAF V600 mutation-positive metastatic melanoma.

Zelboraf is being co-developed under a 2006 license and collaboration agreement between Roche and Plexxikon, a member of the Daiichi Sankyo Group.

About the BRAF protein

The BRAF protein is a key component of the RAS-RAF pathway involved in normal cell growth and survival. Mutations that keep the BRAF protein in an active state may cause excessive signalling in the pathway, leading to uncontrolled cell growth and cancer. These mutations of the BRAF protein are thought to occur in an estimated half of all melanomas and eight percent of all solid tumours.

About BRAF V600 mutation testing

The cobas 4800 BRAF V600 Mutation Test is a polymerase chain reaction-based diagnostic test developed by Roche. The test is approved in Switzerland and the EU (CE Mark). Its ability to identify tumours with the BRAF V600 mutation has been clinically validated in the BRIM2 and BRIM3 studies. The test has several advantages over Sanger sequencing, a commonly used method, including greater sensitivity and reliability in detecting mutations and faster results, allowing doctors to know whether a person with metastatic melanoma is eligible for treatment with Zelboraf.

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 personalized healthcare strategy aims at providing medicines and diagnostic tools that enable tangible improvements in the health, quality of life and survival of patients. In 2011, Roche had over 80,000 employees worldwide and invested over 8 billion Swiss francs in R&D. The Group posted sales of 42.5 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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