Merck Serono's Erbitux is one of the finalists for the prestigious International Prix Galien Award for excellence in pharmaceutical development and innovation due to its role in transforming the treatment of head and neck cancer.

Erbitux is the first and only targeted therapy approved for the treatment of squamous cell carcinoma of the head and neck (SCCHN) and works in a completely different way to conventional chemotherapies. Through its targeted mode of action, Erbitux blocks the epidermal growth factor receptor (EGFR), which is expressed in more than 90 per cent of SCCHN tumours and is directly related to a poor prognosis for patients. The efficacy and tolerability of this novel drug have been shown in clinical trials - the latest of which, EXTREMEa, demonstrated the first significant advance in 30 years for the treatment of recurrent and/or metastatic SCCHN.

"We are very pleased that Erbitux has been short-listed for arguably the most prestigious award in our industry," said Dr Wolfgang Wein, executive vice president, Oncology, Merck Serono. "This recognizes not only the outstanding clinical excellence of Erbitux but also the significant breakthrough that the drug offers patients with head and neck cancer, which is so difficult to treat. Merck Serono is passionate about advancing research across a range of oncology indications and improving the treatments available to cancer patients."

Erbitux is licensed in locally-advanced SCCHN on the basis of data demonstrating that in combination with radiotherapy it achieved locoregional control for more than two years, almost 20 months more than with radiotherapy alone and without increasing the common side effects often observed following such treatment. Five-year survival data from the same trial recently presented at the 50th American Society for Therapeutic Radiology and Oncology (ASTRO) Annual Meeting in Boston showed that nearly half of the patients receiving Erbitux were alive at five years and Erbitux provides a diminution of 27 per cent of the risk of death and an absolute survival benefit of 10 per cent at five years compared to radiotherapy alone.

Erbitux is also demonstrating promise in the treatment of 1st line recurrent and/or metastatic SCCHN. New data from the pivotal EXTREME trial, recently published in the New England Journal of Medicine, demonstrated that when used in combination with traditional chemotherapy, Erbitux provides significant increases in overall survival, median progression-free survival and tumor response rate in the 1st-line treatment setting.3 These results from the EXTREME trial have been used to support an EMEA application to broaden the use of Erbitux to include 1st-line treatment of recurrent and/or metastatic SCCHN, submitted in June 2008.

Erbitux was announced as the winner of the French Prix Galien Award in 2007 and was then submitted to the International Award competition in June 2008. Winners of the 10th International Prix Galien award will be announced in Berlin on October 30, 2008.

The Prix Galien Award was established in France in 1970 to recognize outstanding achievement and innovation in medical research and development.