GSK’s Cervarix® becomes the first cervical cancer vaccine to gain approval in Japan

Landmark approval paves the way for access to the vaccine for women in Japan

Issued: Friday 16 October 2009, London UK

GlaxoSmithKline (GSK) today gained approval for Cervarix^® in Japan, which becomes the first cervical cancer vaccine to be approved by the Japanese Ministry of Health, Labour and Welfare (MHLW).  This approval marks a significant milestone for GSK, as Cervarix^® will be the first vaccine to be launched by the company’s Japanese business.  The vaccine, which is formulated with GSK’s innovative AS04 adjuvant system, has been licensed for the prevention of pre-cancerous lesions (cervical intraepithelial neoplasia – CIN 2 and 3) and cervical cancer (squamous-cell carcinoma and adenocarcinoma) caused by human papillomavirus (HPV) types 16 and 18, in girls and women aged 10 and above.

Cervical cancer currently kills an estimated 3,500 Japanese women each yearand research has shown that incidence of the disease is on the increase, particularly amongst women in their 20’s and 30’s where it is now the leading cause of cancer in the country.

Marc Dunoyer, President of GlaxoSmithKline Japan, commented, “We are extremely pleased with the approval of Cervarix^®,  which is designed to protect women from cervical cancer – a disease that is responsible for the death of 10 Japanese women every day. Experts believe that vaccination in conjunction with regular screening will significantly reduce the burden of cervical cancer, and GSK is committed to working alongside the Japanese government to help ensure that women and girls are educated about the role that vaccination can play in protecting them against it.”

This landmark approval will be the 99^th licence obtained to date around the world.  These include the 27 member states of the European Union (EU), Australia, Brazil, South Korea, Mexico and Taiwan.

Jean Stephenne, President and General Manager of GSK Biologicals commented, “We are delighted by today’s licensing approval in Japan, which will allow Japanese women and girls to join millions of others around the world in being able to benefit from the protection offered by this vaccine.  This is particularly significant considering the increasing rates of incidence of this disease in Japan.  This approval marks a significant milestone for GSK and further reinforces our confidence in the vaccine and the AS04 adjuvant system.”

Included in the submission for this critical licence decision were key data supporting the efficacy and safety profile of the vaccine.  This included the interim analysis of the largest efficacy trial of a cervical cancer vaccine, which involved nearly 19,000 women, a third of which were from Asia. These data demonstrated that the vaccinewas highly effective at protecting against the twomost common cervical cancer-causing HPV types, 16 and 18. The study also showed that rates of serious adverse events and medically significant conditions in the group vaccinated with Cervarix^® were similar to the control group. In addition, a recently published study in the International Journal of Gynecological Cancer, supported these findings, demonstrating that vaccination with Cervarix^® resulted in a strong immune response against HPV types 16 and 18 in Japanese women.

About Cervical Cancer in Japan

Based on the Population Survey Report from the Japanese Ministry of Health, Labour and Welfare, it is estimated that:

•         Approximately 15,000 women are newly diagnosed with cervical cancer (including carcinoma in situ) annually

•         About 3,500 women die from the disease each year in Japan

•         The incidence of cervical cancer is dramatically increasing amongst those in their 20’s and 30’s

•         Cervical cancer is now the leading cause of cancer in women in their 20’s and 30’s

About Cervical Screening in Japan

•         Women over the age of 20 are eligible for screening as part of national or local government schemes

•         Overall participation, including non-government screening programmes is estimated at 24%

About Cervarix ^®

Cervarix ^® was specifically designed with a novel adjuvant, AS04, to deliver high and sustained levels of antibodies aimed at providing long-term protection against HPV 16 and 18, the most common cervical cancer-causing HPV types.  It has been shown to be generally well tolerated.  The most common symptoms after vaccination included pain, redness and swelling at the injection site, fatigue, fever, aching, headache, itching, rash or gastrointestinal disturbances.

To date, Cervarix ^® has now been approved in 99 countries around the world, including Japan, the 27 member states of the European Union (EU), Australia, Brazil, South Korea, Mexico and Taiwan. Licensing applications have been submitted in more than 20 additional countries including the United States. GSK also submitted the vaccine to the World Health Organization (WHO) for prequalification in September 2007. 

The Cervarix^® Summary of Product Characteristics can be found here:

http://emc.medicines.org.uk/medicine/20204/SPC/Cervarix 

About HPV and cervical cancer

Women are at risk of HPV infection throughout their sexually active lives.  Approximately 100 types of HPV have been identified to date and, of these, approximately 15 virus types are known to cause cervical cancer.  HPV types 16 and 18 are responsible for approximately 70 per cent of cervical cancers globally, with types 45, 31 and 33 among the next most common cervical cancer-causing HPV strains. Persistent infection with cancer-causing HPV types can lead to abnormal Pap smears, cervical pre-cancer and cervical cancer. Cervical intraepithelial neoplasia (CIN), graded as CIN 1, 2 and 3 refers to pre-cancerous cells found on the surface of the cervix.  The higher the grading number, the higher the probability the abnormal cells will become cancer cells. CIN 1, 2 and 3 refers to mild, moderate or severe cell changes respectively. CIN 2+ is the surrogate marker for cervical cancer. Worldwide, more than 500,000 women will be newly diagnosed with cervical cancer and 280,000 women will die from it each year.

HPV types 16, 18 and 45 are particularly important because these types are associated with nearly 90 percent of adenocarcinoma cases; a very aggressive type of cervical cancer more common in younger women and more difficult to detect through screening.

GlaxoSmithKline Biologicals –GSK Biologicals, GlaxoSmithKline’s vaccines business, is one of the world’s leading vaccine companies and a leader in innovation. The company is active in the fields of vaccine research, development and production with over 30 vaccines approved for marketing and 20 more in development. Headquartered in Belgium, GSK Biologicals has 13 manufacturing sites strategically positioned around the globe. In 2008 GSK Biologicals distributed 1.1 billion doses of vaccines to 176 countries in both the developed and the developing world – an average of 3 million doses a day.

Through its accomplished and dedicated workforce, GSK Biologicals applies its expertise to discover innovative vaccines that contribute to the health and well-being of people of all generations around the world.

GlaxoSmithKline – One of the world’s leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer.  For further information please visit www.gsk.com

Cervarix ^® is a registered trademark of the GlaxoSmithKline group of companies.