Investor Update

Basel, 20 December 2012

Roche's vismodegib named Drug Discovery of the Year by the British Pharmacological Society

Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the first in class Hedgehog pathway inhibitor vismodegib, was named Drug Discovery of the Year by the British Pharmacological Society. The award, which celebrates the importance of pharmacology in the development of new medicines, was presented to the vismodegib team because of the detailed pharmacokinetic/pharmacodynamic analysis that was completed during the drug development process. Vismodegib is currently approved in the US and Mexico for the treatment of adults with an advanced form of the common skin cancer basal cell carcinoma.

Vismodegib works by selectively targeting and blocking abnormal signals in a pathway involved in regulating growth and development in the early stages of life (the Hedgehog signalling pathway). As a person matures, the Hedgehog signalling pathway normally becomes less active, working only to maintain or repair tissue. However in some people malfunctions or abnormal activation occurs; such abnormal activation has been shown to play an important role in the development of certain types of cancer.

Rick Graham,  Clinical Pharmacologist and acting Global Development Leader for vismodegib at Genentech, commented, “We are very proud that our understanding of the Hedgehog signalling pathway enabled us to develop a medicine which today is providing meaningful benefit to patients with advanced basal cell carcinoma.”

Nearly all (90 percent) advanced basal cell carcinoma lesions demonstrate abnormal activation of the Hedgehog signalling pathway, and in both a clinical and real world setting, treatment with vismodegib has been shown to provide significant clinical benefit and to set a new standard of care for patients with this potentially disfiguring and debilitating disease.

The British Pharmacological Society’s Drug Discovery of the Year award celebrates the importance of pharmacology in the development of new medicines. The winning team was selected by a judging panel of experts in industrial pharmacology, following nominations made to BPS by its members worldwide.

About vismodegib

Vismodegib is an investigational medicine designed to selectively target abnormal signalling in a cell growth pathway, known as the Hedgehog signalling pathway which is implicated in the development of certain types of cancer, including basal cell carcinoma.

Basal cell carcinoma is the most common type of skin cancer in Europe, Australia and the United States. In advanced basal cell carcinoma, if the disease is left untreated or recurs in the same location after surgery or radiotherapy, it may advance further into surrounding areas such as sensory organs (ears, nose and eyes), bone, or other tissues. Depending on the location of the lesion, some cases of advanced basal cell carcinoma can be disfiguring, and treatment with surgery or radiation can lead to the loss of sensory organs and their functions such as eyesight or hearing.

In January 2012 vismodegib became the first licensed medicine for patients with advanced forms of basal cell carcinoma when it was approved by the U.S. FDA under the brand name Erivedge™. It has since been approved by the Federal Commission for Protection Against Health Risks in Mexico.

Roche has submitted a marketing approval application for vismodegib to the European Medicines Agency and is working closely with regulatory authorities in other countries to make the medicine available to patients with advanced basal cell carcinoma as quickly as possible.

Roche is developing vismodegib under a collaboration agreement with Curis, Inc. Vismodegib was discovered by Genentech and jointly validated by Genentech and Curis through a series of preclinical studies. Through this collaboration, Genentech (U.S.), Roche (ex-U.S. excluding Japan) and Chugai Pharmaceuticals (Japan) are responsible for the clinical development and commercialisation of vismodegib. Curis is eligible to receive cash payments upon the successful achievement of specified clinical development and regulatory approval milestones, as well as royalties upon commercialisation of vismodegib.

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.

All trademarks used or mentioned in this release are protected by law.

About the Drug Discovery of the Year award

The award neither promotes the administration, consumption, prescription, purchase, recommendation, sale, supply or use of the winning medicine; nor does it pre-empt any regulatory decisions in Europe. The BPS Industry Committee consists of experts in industrial pharmacology and invited applications using the following criteria:

  • the drug should have been launched within the last 3 years
  • its preclinical to clinical translation should show the importance of pharmacology in the drug discovery/development process
  • the drug should have a significant impact on an unmet medical need
  • it should be first-in-class, or a significant improvement from a pharmacological perspective over other drugs in the class
  • its mechanism of action should be known