Source: www.medicalnewstoday.com
Author: staff

Gardasil®, the four-type (6,11,16,18) human papillomavirus (HPV) vaccine, has been awarded the 2008 International Galien Prize, a prestigious award for recognising and promoting significant advances in pharmaceutical research which is considered the pharmaceutical industry equivalent of the Nobel Prize.

“It is gratifying to be part of the transformation of scientific breakthrough into actual benefits for people’s health,” says Didier Hoch, President of Sanofi Pasteur MSD. “Only 30 years after the discovery that HPV can cause cervical cancer and many other diseases we hold today a vaccine in our hands that can save lives and prevent the suffering of thousands and millions of women. This is unprecedented progress in medical and pharmaceutical research.”

From 2006 to 2008, Gardasil® has won national Galien Prizes in Belgium, France, Netherlands, Switzerland, the US and the UK (the two HPV vaccines currently licensed for use in the UK were jointly awarded the Galien prize in the palace of Westminster, in September 2008). Additionally, Gardasil® has garnered a number of other prizes, including the 2006 Scrip Award by the British pharmaceutical newsletter Scrip for “Best new biological product” and 2007 Medec Prize by the French general practitioners for “Medicine of the year.”

During the 1970s, Professor Harald zur Hausen, the Co-Laureate of this year’s Nobel Prize in Physiology or Medicine, postulated the role of HPV in causing cervical cancer. He pursued this idea for more than 10 years by searching for different HPV types, which culminated in the discovery in 1983 of HPV 16 as a cause of cervical cancer. In 1984, Harald zur Hausen succeeded in isolating and cloning HPV16 and 18 from patients with cervical cancer.1 Today, it is known that HPV types 6, 11, 16 and 18 cause the vast majority of HPV-related genital diseases.2,3,4

The development of Gardasil® started in the early 1990s. Today, two years after the first approval in 2006, it is approved in 107 countries and widely implemented with 36 million doses distributed worldwide by end of September 2008, and about 90% global market share (in value, implied from public financial disclosures by Merck & Co. Inc and GSK: third quarter 2008: 89.5%, cumulative (year to date): 92.7%). These figures reflect the strong endorsement by experts, regulators, health authorities, physicians, parents and daughters.

Gardasil® is the only four-type (6,11,16,18) human papillomavirus (HPV) vaccine. In addition to cervical cancer protection, Gardasil® is licensed for the prevention of the cervical, vulvar and vaginal pre-cancer, and from genital warts caused by HPV types 6, 11, 16 and 18. These four types together cause the vast majority of HPV-related genital diseases.2,3.4 Gardasil® is available in the UK and is indicated for females 16 – 26 years of age and in 9 to15 years old child and adolescents.

More about Gardasil
Gardasil® is a vaccine for the prevention of premalignant genital lesions (cervical, vulvar and vaginal), cervical cancer and external genital warts (condyloma acuminate) causally related to Human Papillomavirus (HPV) types 6, 11, 16 and 18. The indication is based on the demonstration of efficacy of Gardasil® in adult females 16 to 26 years of age and on the demonstration of immunogenicity of Gardasil® in 9- to 15-year old children and adolescents. Protective efficacy has not been evaluated in males. The use of Gardasil® should be in accordance with official recommendations.

About International Galien Prize
The Galien Prize was created in 1970 by the French pharmacist Roland Mehl to promote significant advances in pharmaceutical research. Each year, the award, decided by a prominent jury of clinicians, toxicologists, pharmacologists and pharmacists, provides 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. Following its initial success in France, similar initiatives started to take off in other countries, including Belgium, Luxembourg, Germany, Netherlands, UK, Italy, Spain, Portugal, Canada, Switzerland and US. A European Galien Prize, the predecessor of the International Galien Prize, was created in 1990 to reward one of the winners of the national Galien Prizes of the two previous years. With the introduction of the Galien Prize in Canada in 1996, the European Galien Prize became the International Galien Prize and is now awarded once every two years. For more information about the International Galien Prize, go to: http://www.prixgalien.com

About Sanofi Pasteur MSD
Sanofi Pasteur MSD is a joint venture between sanofi pasteur, the vaccine division of sanofi-aventis, and Merck & Co., Inc. Combining innovation and expertise, Sanofi Pasteur MSD is the only company in Europe dedicated exclusively to vaccines. Sanofi Pasteur MSD is able to draw on the research expertise of sanofi pasteur and Merck & Co., Inc., together with their teams throughout the world, to focus on the development of new vaccines for Europe, which aim to extend protection to other diseases and perfect existing vaccines in order to improve the acceptability, efficacy and tolerability of vaccination. http://www.spmsd.com/

References
1. http://nobelprize.org/nobel_prizes/medicine/laureates/2008/press.html (Last acceded 22 October 2008)

2. Smith JS et al. Human papillomavirus type distribution in invasive cervical cancer and highgrade cervical lesions: A meta-analysis update. Int J Cancer 2007; 121:621-632

3. Gardasil®, Summary of Product Characteristics, September 2008

4. Gardasil®, European Product Assessment Report (EPAR), Scientific Discussion, http://www.emea.europa.e/humandocs/PDFs/EPAR/gardasil/070306en6.pdf