Gardasil: Protection Against Cervical Cancer

PUBLICATION OF LANDMARK GARDASIL CLINICAL TRIALS IN THE NEW ENGLAND JOURNAL OF MEDICINE

GARDASIL PROVEN TO PROVIDE ADDITIONAL PROTECTION AGAINST CERVICAL CANCER

The landmark GARDASIL clinical trials FUTURE I and FUTURE II were published in the New England Journal of Medicine (NEJM) today. These clinical trials show that GARDASIL, the world’s first cervical cancer vaccine, provides significant and sustained protection against cervical cancer and human papillomavirus (HPV) related-disease.

In the two Phase III GARDASIL studies (FUTURE I and FUTURE II) of more than 15,000 women (aged 15 – 26 years), GARDASIL provided 100% protection against advanced cervical pre-cancers, cervical cancer and vaginal and vulvar pre-cancers and cancers, caused by the four HPV types GARDASIL is designed to protect against (16, 18, 6 and 11). GARDASIL was also 100% protection against genital warts caused by HPV types 6 and 11.

Results from these published Phase III studies represent an additional year of efficacy data and confirm that GARDASIL provided sustained protection through the three years of the trials, including an additional year of follow up since the registration of GARDASIL.

Also, as part of its clinical program, CSL Biotherapies partner Merck & Co. Inc. has followed a subset of women who participated in its Phase II clinical studies. Merck now has data from five years of follow-up on these women and no cases of infection and disease caused by waning immunity was seen.

Professor Ron Jones, Professor of Obstetrics and Gynaecology, National Women’s Health explains “These are the most comprehensive data available for a vaccine to help prevent cervical cancer. In these two trials (FUTURE I & FUTURE II), the quadrivalent vaccine, Gardasil, demonstrated 100% protection against serious HPV-related disease, including high-grade cervical pre-cancers, in women not previously exposed to the relevant HPV types. These two studies also represent the first data to show the impact of HPV vaccination on vulvar and vaginal cancers and genital warts.”

In addition, Merck has submitted a supplemental Biologics License Application (sBLA) for GARDASIL to the U.S. FDA to update the labeling for GARDASIL.

The new submission for GARDASIL includes efficacy data showing cross-protection against a number of additional cervical cancer-causing HPV types, potentially increasing GARDASIL’s total prevention against cervical cancer to greater than 80%.

The new submission also includes additional data that shows GARDASIL induces immune memory, which is a hallmark of vaccines that induce long-term protective efficacy.

“We are aiming to submit this exciting data to Medsafe by the end of the month with complete results of cross-protection data being presented at scientific conferences later in the year,” says CSL Biotherapies (NZ) Ltd spokesperson.

GARDASIL has been approved in more than 70 countries including New Zealand, Australia, US, Canada, the 27 countries of the European Union, Mexico, Taiwan, and Brazil. Additional applications for GARDASIL are currently under review with regulatory agencies in more than 50 countries around the world.

GARDASIL is currently funded in Australia, the US and many other countries.

“Every year there are 30,000 abnormal smears in New Zealand with approx 4,200 being high grade and requiring extensive follow-up and treatment. Each year 180 New Zealand women are diagnosed with cervical cancer and 60 women die from cervical cancer. GARDASIL could drastically reduce the incidence of the above life changing events straight away and reduce significantly the unacceptably high level of preventable deaths in the long-term. GARDASIL and regular pap smears are the best protection against cervical cancer” says CSL Biotherapies (NZ) Ltd spokesperson.

ENDS

About CSL Biotherapies
CSL Biotherapies (NZ) Ltd is part of a global, specialty biopharmaceutical company that develops, manufactures and markets products to treat and prevent serious human medical conditions. Innovation and new product development for unmet medical needs continue to drive CSL’s growth. CSL was set up in New Zealand in 1992 to provide a range of vaccines and medications to the New Zealand population. Over the past 14 years CSL has also held contracts with the NZ Government to supply vaccines ranging from influenza, tetanus, diphtheria and combination vaccines.

CSL and Merck & Co
Fundamental technology, contributing to the development of GARDASIL, was discovered in 1991 at the University of Queensland by Professor Ian Frazer and Dr Zhou in collaboration with CSL Limited. In 1995 CSL licensed this technology to Merck & Co., Inc. - parent company of Merck Sharp & Dohme New Zealand (MSD NZ). Merck then undertook an extensive clinical trial programme leading to the development of GARDASIL. CSL will market GARDASIL in New Zealand and Australia. Merck & Co., Inc. will market the vaccine in the rest of the world. MSD NZ has also contributed to the international research efforts for the vaccine by co-ordinating a Phase III clinical trial, with sites in Auckland and Christchurch.

For more information on HPV-related disease (cervical, vaginal, vulvar pre-cancers and cancers and genital warts) and FUTURE I & FUTURE II clinical studies please contact:

GARDASIL® is a registered trademark of Merck and Co Inc., Whitehouse Station, N.J, USA.

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