Roche’s Zelboraf wins 2013 Swiss Prix Galien for pharmaceutical innovation

Basel, 03 July 2013

Roche has been awarded this year’s prestigious Swiss Prix Galien for Zelboraf (vemurafenib), a medicine used to treat malignant melanoma, the most aggressive and a deadly form of skin cancer. Zelboraf is used with a companion diagnostic test that enables doctors to identify patients likely to respond to treatment.

While melanoma is one of the most aggressive cancers, it is normally curable if detected early. Once it has spread (metastasized) to other parts of the body, however, it is fatal. The life expectancy of people with metastatic melanoma is generally short, with only about 25% of patients surviving for at least one year after diagnosis. Zelboraf is the only personalised medicine shown in pivotal clinical trials to significantly extend the survival of both previously treated and previously untreated patients with advanced malignant melanoma.

For over 40 years the prestigious Galien prizes have been awarded annually for outstanding advances in pharmaceutical research. In addition to a number of national Galien awards, there is also an international prize. Commenting on this year’s Swiss award, jury member Professor Christian Ludwig said: ‘The Swiss Prix Galien jury regards Zelboraf as an impressive example of effective, targeted drug development. Thanks to a companion diagnostic test, doctors can identify the patients most likely to benefit from treatment. Roche developed both the test and the medicine and brought them to market within a short time. That’s impressive.’

Also commenting on the award, Manfred Heinzer, General Manager of Roche Pharma (Switzerland) Ltd. noted: ‘Zelboraf is a milestone in the treatment of patients with metastatic melanoma. And having a drug-diagnostic combination receive this kind of recognition for innovation is a great success for Roche.’

The Swiss Prix Galien isn’t Zelboraf’s first. Last year the medicine was similarly honoured in Germany.

About the Prix Galien

The Prix Galien is sponsored in Switzerland by the Medical Tribune newspaper. To be eligible for consideration, a medicine has to have been on the market in Switzerland for at least one year. Candidates are assessed by a national jury of experts from different fields. Professor Edouard Battegay of Zurich University Hospital is the current jury president. Winners of the Swiss Prix Galien are eligible to compete for the international Galien award.

About Zelboraf

Zelboraf is an oral medicine that inhibits the uncontrolled growth of cancer cells carrying mutated forms of the BRAF protein. These mutations, found in about half of all melanoma patients, 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 the mutated proteins and who are therefore likely to benefit from therapy. Zelboraf was developed in record time, reaching the market less than 10 years after the BRAF drug target was first described in the journal Nature and just five years after the start of clinical development.

About the cobas 4800 BRAF V600 Mutation Test

The cobas 4800 BRAF V600 Mutation Test is a polymerase chain reaction-based diagnostic test developed by Roche. The test has been approved by the US Food and Drug Administration, and its ability to identify tumours with the BRAF V600E mutation has been clinically validated in the BRIM2 and BRIM3 studies. The test has several advantages over the widely used Sanger sequencing method, including greater sensitivity and reliability in detecting mutations and faster results indicating 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, infectious diseases, inflammation, metabolism and neuroscience. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner 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 2012 Roche had over 82,000 employees worldwide and invested over 8 billion Swiss francs in R&D. The Group posted sales of 45.5 billion Swiss francs. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com.

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