Valdoxan® (agomelatine): Award of the Italian Prix Galien 2012


Paris, November 30, 2012

Valdoxan, a new antidepressant developed by Servier research, has won the 2012 Italian Prix Galien Innovative Product Award. This prestigious prize, one of the most important awards in the field of biomedical and pharmacological therapy, is the recognition of the innovation that represents Valdoxan.

Valdoxan, a step further in depression management

Valdoxan is the result of 18 years of research conducted by Servier.  It was approved by the European Medicines Agency in February 2009 and is registered in 74 countries. To date, almost 3 million depressed patients have benefited from Valdoxan. The safety and efficacy of Valdoxan have been demonstrated in six short-term and one long-term international maintenance clinical trials in more than 7000 patients.

“Valdoxan has a mechanism of action that is radically different from all other antidepressants used so far”, said Professor John Biggio, President SINPF (Italian Society of Neuropsychopharmacology) and Professor of
Neuropsychopharmacology, University of Cagliari.

This prize bears witness to the vigor and productivity of research at Servier, which is committed to therapeutic advances in psychiatry.

Depression, one the most disabling disease

Depression is a disease that affects around 10% of the adult population. It is one of the most disabling and costly disease that is not yet well managed. It was considered as the 4th cause of burden in 2000 and is expected to be the largest cause of global health burden by 2020 (Moussavi et al, 2007).

About the Prix Galien

The prix Galien was created in France in 1970 by a pharmacist named Roland Mehl. Its aim was to promote significant advances in pharmaceutical research. Until the creation of the Prix Galien, this field of research had remained largely unrecognized.

A prominent jury was brought together, including clinicians, toxicologists, pharmacologists and pharmacists. Each year, the award has been an opportunity to give credit to the most important drugs introduced into the public market as well as to the achievements of the best research team in the pharmaceutical field. Since its creation, the Galien award has grown into a major event. It is seen as an influential event by all those interested in pharmaceutical research, including public authorities, scientists, pharmaceutical companies and medical press groups. For this reason, it is also considered as the industry’s equivalent of the Nobel prize and the highest accolade for pharmaceutical research and development.

The importance of the Prix Galien in France has led to similar initiatives in several other countries. The first countries other then France to create their own Galien award were Belgium and Luxemburg in 1982, followed in 1984 by Germany, and in 1985 by the Netherlands. In 1988 the United Kingdom created a Galien award, followed in 1989 by Italy, in 1990 by Spain, in 1992 by Portugal, in 1993 by Canada, in 2001 by Switzerland and in 2007 by the United States, in 2012, Poland, Israël, Greece and Singapore.

Valdoxan Summary of Product Characteristics