Media Release

Basel, 29 November 2012

Roche's Zelboraf named Best New Drug at the 2012 Scrip Awards

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that its cancer drug Zelboraf (vemurafenib) won the Best New Drug award at the 2012 Scrip Awards ceremony held in London last night.

Until recently patients with metastatic melanoma could only expect to live for as little as six to nine months after diagnosis. Zelboraf, the first and only approved BRAF inhibitor, is helping to change the outlook for a targeted group of patients with this devastating form of skin cancer, stalling the growth or spread of the cancer and extending life expectancy beyond one year for many patients.

The drug, a targeted treatment for BRAF V600 mutation-positive metastatic melanoma, licensed from and developed in collaboration with Plexxikon Inc. was approved alongside a companion diagnostic, the cobas 4800 BRAF Mutation Test, by the FDA in August 2011 and the EMA in February 2012.

Receiving the award on behalf of Roche, Joerg Kazenwadel, commented, “Whilst we are very proud of Zelboraf and its status as a truly innovative medicine, we are most proud of what it can offer to patients with metastatic melanoma. We are thrilled that the Scrip Awards panel has recognised our efforts in developing this unique medicine.”

Kathleen Glaub, President of Plexxikon, added, “We first approached Roche in 2005 to develop a companion diagnostic for vemurafenib. We quickly realised that Roche should be our development partner of choice due to the company’s commitment to personalised healthcare. Through our successful collaboration we were able to rapidly advance clinical development and achieved marketing approval for this important medicine in fewer than five years.”

Today, Zelboraf is approved in over 40 countries and has been used for the treatment of more than 11,000 patients worldwide. It is rapidly becoming the standard of care for BRAF V600 mutation-positive metastatic melanoma.

The Scrip Awards showcase the most outstanding players in pharma and biotech, providing an opportunity to acknowledge and applaud the highest achievers in the industry. The other candidates shortlisted for Best New Drug were Incyte’s Jakafi (ruxolitinib) and Regeneron Pharmaceuticals’ Eylea (aflibercept).

About Zelboraf

Zelboraf is a personalised oral medicine designed to specifically inhibit the activity of the mutant BRAF protein. It is the first and only approved BRAF inhibitor and has been proven to help patients with BRAF V600 mutation-positive metastatic melanoma in two important ways; it stalls the growth or spread of the cancer and helps patients survive longer, extending life expectancy beyond one year for many patients.

Clinical experience with Zelboraf is growing every day; it is already approved in over 40 countries and has been used for the treatment of more than 11,000 BRAF V600 mutation-positive metastatic melanoma patients worldwide.

To further enhance the potential treatment options available to patients at all stages of the disease, Roche is building on its extensive clinical experience with Zelboraf to investigate a number of combination approaches, including Zelboraf with the MEK inhibitor GDC-0973 and Zelboraf with immunotherapies.

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

GDC-0973 [XL518] is a potent, highly selective inhibitor of MEK, a serine/threonine kinase that is a component of the RAS/RAF/MEK/ERK pathway. GDC-0973 is being developed by Genentech, a member of the Roche Group, under a collaboration agreement with Exelixis.

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:

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