Cervarix related Press Releases

Cancer Vaccines Poised to Reach $3 Billion in Sales by 2015

Tue, 19 Apr 2011 11:20:35 -0400

FALLS CHURCH, Va., April 19, 2011 /PRNewswire/ -- Technology Catalysts International (TCI), leading global consultants to the pharmaceutical industry, announced that research on cancer trends and development has identified cancer vaccines as a viable treatment option for a variety of cancers that currently have ineffective treatments. The potential of the cancer vaccine market is forecast to approach $3 billion in 2015.

With the Medicare advisory committee's recent recommendation to support Dendreon's expensive prostate cancer vaccine, Provenge®, the field of cancer vaccines has received an unprecedented boost. As a result, many companies are expected to enter this emerging and highly profitable field of preventing, treating, and potentially curing cancer. Prophylactic cancer vaccines, Gardasil® by Merck and Cervarix® by GSK, have already gained worldwide attention with their blockbuster status/potential.

Dr. Joseph Pantginis of Roth Capital Partners, a full service investment banking firm, recently evaluated the BiovaxID® technology from Biovest International and believes that this vaccine will be the next success, even though there are certain risks involved including the path to market for BiovaxID. However, in spite of the risks, Dr. Pantginis feels cancer immunology is coming of age and that BiovaxID can be successful even when two prior idiotype vaccines (developed by Genitope and Favrille) have failed. According to Dr. Pantginis, there are two main reasons why BiovaxID is believed to have succeeded where the others have failed 1) critical data at the ASH 2010 conference were presented demonstrating that a vaccine against IgM and not igG is the reason for BiovaxID's success and 2) BiovaxID uses the entire idiotype from a patient to manufacture the vaccine whereas Genitope and Favrille used recombinant portions of the idiotype.

The greatest challenges to a successful vaccine development program are seeking the right antigen, selecting the right adjuvant, and developing an effective targeting technology. Technology Catalysts' newly-released Cancer Vaccines report profiles companies that are developing novel approaches to successfully create effective cancer vaccines and overcome these hurdles.

To leapfrog the development process and enter into strategic alliances, the report provides detailed descriptions of more than 35 companies that have active developments in various approaches to cancer vaccines and are open to strategic alliances. The report also analyzes the current technology and market potential for cancer vaccines and features a pipeline overview, market analysis, and a summary of recent deals associated with cancer vaccines. In addition, the report provides detailed descriptions of novel technologies designed for the development of cancer vaccines. The information is confirmed via company interviews and includes full contact information for easy follow-up and business development opportunities.

A complimentary excerpt of this report is available for download at:

http://www.technology-catalysts.com/pdf/CancerVaccines_Brochure.pdf

About Technology Catalysts International:

Technology Catalysts International ("TCI") was founded in 1979 and provides consulting services in technology transfer and business research. The company specializes in technology licensing, technology assessment, and business intelligence. With a focus on pharmaceuticals, drug delivery, consumer healthcare, and advanced materials/processes, TCI's core consulting services are based on continuous monitoring of technological product development activities on a global basis. TCI is headquartered in the US and has offices in the UK, Germany, Czech Republic, China, Korea, Japan, India, and Latin America.

Contact:
Ajay Rastogi, Vice President
Technology Catalysts International
Telephone (703) 531-0257
arastogi@technology-catalysts.com
http://www.technology-catalysts.com

SOURCE Technology Catalysts International

New data for GlaxoSmithKline's vaccine, Cervarix, presented at IPV Conference

Calisha Myers — Fri, 08 May 2009 11:18:33 -0400

New data for GlaxoSmithKline's vaccine, Cervarix, presented at IPV Conference

Issued: Friday 8 May 2009, London, UK & Malmö, Sweden

Key results from three important studies of the cervical cancer vaccine, Cervarix®, will be available as of today at the 25th International Papillomavirus Conference (IPV) in Malmö, Sweden.

Comparative trial of Cervarix® and Gardasil® (Study 010)
Results from the first, large-scale comparative trial between licensed human papillomavirus (HPV) vaccines show that Cervarix® generated a significantly higher immune response compared to Gardasil® .1 The comparative study looked at two key measures of immune response, neutralising antibodies and memory B cells. Although the post-vaccination immune correlates of protection for cervical cancer are still unknown, neutralising antibodies and B cells are believed to play an important role in protecting women from HPV infection and subsequent cervical cancer over the long term.2-7 Across all ages studied (women 18 - 45 years), neutralising antibody levels for Cervarix ® were more than two times higher than those for Gardasil ® for HPV type 16, and more than six times higher for HPV type 18. These results were highly statistically significant (p<0.0001).1 In addition, the proportion of women with detectable levels of neutralising antibodies in cervical secretions was higher in the group that received Cervarix® .1 Compared toGardasil® , GSK's vaccine also produced nearly three (2.7) times more memory B cells for HPV types 16 and 18.1

Compliance with the full vaccination course was high and comparable for both vaccines8 which indicates that both were well tolerated. Rates of solicited symptoms were higher for Cervarix® with injection site reactions being most common.8 However, in both groups solicited symptoms tended to be of short duration. It is expected that the full results from this comparative study will be published in a peer reviewed journal.

Thomas Breuer, Head of Global Clinical R&D and Chief Medical Officer of GSK Biologicals commented: "The presence of neutralising antibodies at the location of the infection (the cervix) appears to be an important part of vaccine-induced protection against HPV. This study offers the first evidence that these two vaccines do not generate the same immune response against HPV types 16 and 18, the two most common cancer-causing virus types. We are confident that these results, along with new results from additional key studies being presented this week, demonstrate the potential of Cervarix® ."

Phase III efficacy trial (Study 008)
Results from the final analysis of the Phase III study (HPV-008) will be presented for the first time at the conference, showing that Cervarix® provided a high and statistically significant level of efficacy against pre-cancerous lesions associated with each of the HPV types included in the vaccine (HPV 16 and HPV 18).9 In addition,the data demonstrated that the vaccine also provided type-specific protection against pre-cancerous lesions associated with some additional common cancer-causing HPV types other than HPV 16 and HPV 18.10 In women without evidence of prior cancer-causing HPV infection the overall efficacy demonstrated against any lesion, regardless of HPV type, was much greater than would be expected for a vaccine targeting only HPV types 16 and 18.11

Rates of serious adverse events and medically significant conditions were similar between study and control groups.9 These data have been submitted to regulatory authorities including the US FDA and publication is expected in a peer reviewed journal.

Long term follow up study (Study 023)
Results from a third study to be presented in Malmö show that GSK`s cervical cancer vaccine provided high and sustained antibody levels against HPV 16 and HPV 18 through the 7.3 years of follow up after vaccination. This is the longest follow up reported to date for any licensed HPV vaccine.12

Jean Stéphenne, President and General Manager of GlaxoSmithKline Biologicals said, "Preventing cervical cancer is a public health priority in both developed and developing countries. We are pleased with these findings and how they can further the understanding of the role of Cervarix ® in helping to protect women against cervical cancer."

Notes to editors

About HPV 008
The efficacy and safety results from the interim analysis of the HPV 008 study were previously published in The Lancet.13 The data presented at the 25th International Papillomavirus Conference (IPV) are from the final event driven analysis. Further follow up results will be forthcoming from the end of study analysis in due course.

About the HPV vaccines
Cervarix ® provides protection against the most common cancer-causing virus types - HPV 16 and 18.9 Gardasil ® provides protection against HPV 6, 11, 16 and 18.

Cervarix ® was specifically designed with a novel adjuvant, AS04, to deliver high and sustained levels of antibodies aimed at providing long-term protection against the most common and aggressive HPV types.14 It has been shown to be generally well tolerated. The most common symptoms after vaccination included pain, redness and swelling at the injection site.15

To date, Cervarix ® has been approved in 95 countries around the world, including 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 Japan and the United States. GSK also submitted the vaccine to the World Health Organization (WHO) for prequalification in September 2007.

About HPV and cervical cancer
Women are at risk of HPV infection throughout their sexually active lives.16 Approximately 100 types of human papillomavirus have been identified to date17 and, of these, approximately 15 virus types are known to cause cervical cancer.18 HPV types 16 and 18 are responsible for approximately 70 percent of cervical cancers globally, with types 45, 31 and 33 among the next most common cancer-causing HPV strains.19,20 Persistent infection with cancer-causing HPV types can lead to abnormal Pap smears, cervical pre-cancer and cervical cancer. Worldwide, more than 500,000 women will be newly diagnosed with cervical cancer21 and 280,000 women will die from it each year.21

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.

Gardasil ® is a registered trademark of Merck & Co., Inc.

GlaxoSmithKline submits final study data to FDA for cervical cancer vaccine

Calisha Myers — Thu, 02 Apr 2009 10:13:01 -0400

Cervarix® U.S. regulatory update

GlaxoSmithKline submits final study data to FDA for cervical cancer vaccine

Issued: Monday 30th March 2009, Philadelphia US & London UK

GlaxoSmithKline today provided the following update regarding its application to the U.S. Food and Drug Administration (FDA) for approval of CERVARIX®, its vaccine to prevent cervical cancer and cervical pre-cancer related to human papillomavirus types 16 and 18.

GSK has submitted final data from its Phase III pivotal efficacy study, HPV-008, to the FDA. The FDA has previously reviewed interim data from the same trial. FDA review of this type of Biologics License Application (BLA) submission is expected to take six months, according to agency regulations.

"We are pleased to have reached this significant milestone for CERVARIX®. The data submitted to the FDA reaffirm our confidence in the vaccine's safety and efficacy profile," said Barbara Howe, M.D., Vice President and Director, North American Vaccine Development, GlaxoSmithKline. "We will continue working closely with the FDA in order to make this vaccine available to help protect the cervical health of girls and women in the U.S."

HPV-008 is a Phase III clinical study of more than 18,600 women between 15-25 years of age, from 14 countries across Europe, Asia-Pacific and Latin and North America. The primary objective was to assess vaccine efficacy in the prevention of high-grade pre-cancerous cervical lesions (CIN2+) caused by human papillomavirus types 16 or 18. Secondary objectives included evaluation of vaccine efficacy in the prevention of pre-cancerous cervical lesions (CIN1+) and infections caused by virus types 16 or 18 or other cancer-causing virus types, as well as immune response and safety. GSK will submit the data to a peer-reviewed journal in the coming months.

The BLA for the vaccine includes safety, efficacy and immune response data from clinical trials in nearly 30,000 females and reflects an ethnically diverse population.

To date, GSK's vaccine has been approved in more than 90 countries around the world including the 27 member countries of the European Union, Mexico, Australia, Singapore and the Philippines. Licensing applications have been submitted in more than 20 additional countries including Japan. GSK also submitted the vaccine to the World Health Organization (WHO) for prequalification in September 2007.

Notes to Editors

Cervical Health Facts - Worldwide, every two minutes a woman dies of cervical cancer; each year more than 500,000 women will be newly diagnosed and more than 280,000 women will die. In the U.S., after breast cancer, cervical cancer is the leading cause of cancer-related death in women between the ages of 20 to 39 in the United States. Also, in the U.S. each year there are an estimated 3.5 million abnormal Pap smears, and more than 1.5 million precancerous lesions are diagnosed.

GlaxoSmithKline Biologicals - GSK'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.

CERVARIX® is a registered trademark of the GlaxoSmithKline group of companies.

PRESS RELEASE: GSK submits Cervarix licence application to Japanâ€™s health authorities

Maureen Martino — Thu, 04 Oct 2007 12:19:19 -0400

GSK submits Cervarixâ„¢ licence application to Japanâ€™s health authorities

For UK business and financial media (not for distribution to US media)

Issued â€“ 28 September 2007, London (UK) and Rixensart (Belgium) - GlaxoSmithKline (GSK) today announced that it has submitted a licence application for its cervical cancer candidate vaccine Cervarixâ„¢ to the Japanese Ministry of Health, Labor and Welfare (MHLW). This is the first vaccine for the prevention of cervical cancer to be filed for approval in Japan.

GSKâ€™s cervical cancer candidate vaccine is formulated with a novel proprietary adjuvant system called AS04, intended to enhance immune response and increase duration of protection. The licence applied for is for the prevention of cervical cancer and precancerous lesions associated with the most common cancer-causing human papillomavirus types.
The incidence of cervical cancer in Japan is on the increase.[1] With 2,500 deaths[2] and 7,000 new cases diagnosed per year2, cervical cancer has become the most common cancer in Japanese women in their 20s and 30s and the second most common cancer in Japanese women overall.2

â€œWith rising rates of cervical cancer, especially in younger Japanese women, Japanis a priority country for GSKâ€™s cervical cancer candidate vaccine, said Jean StÄ—phenne, President and General Manager, GSK Biologicals.

â€œThis filing submission includes a vast amount of data on the efficacy and safety of the candidate vaccine in Asian women. The submission follows other recent approvals across the Asia-Pacific region, and launches in Australiaand the Philippines. We look forward to the opportunity of ensuring that Japanese women will equally have access to our vaccine, for protection against this life-threatening disease.â€

The file submitted to the MHLW includes data from clinical trials in almost 30,000 females 10 to 55 years of age across four continents. The submission also included data from the largest Phase III cervical cancer vaccine efficacy trial to date[3],which demonstrated that GSKâ€™s cervical cancer candidate vaccine was highly efficacious and was generally well tolerated. A third of patients in this key trial were from Asia[4], which means that we have a very balanced population included in the trial.

Recent European marketing authorisation, granted on 21st September 2007, indicates GSKâ€™s cervical cancer candidate vaccine for the prevention of precancerous cervical lesions (high-grade cervical intraepithelial neoplasia [CIN] grades 2 and 3) and cervical cancer causally related to human papillomavirus (HPV) types 16 and 18.[5] The indication isbased on data generated in girls and women aged between 10 and 25.[6],[7]

Novel adjuvant system

GSKâ€™s cervical cancer candidate vaccine is formulated with a novel proprietary adjuvant system called AS04, which is designed to enhance the immune response and increase the duration of protection against cancer-causing virus types.

Published data have shown that the candidate vaccine, formulated with this adjuvant system, induces an immune response of higher magnitude and persistence compared to the same vaccine composition, formulated with conventional aluminium hydroxide adjuvant alone.[8]

About Cervarixâ„¢ regulatory progress

GSKâ€™s cervical cancer candidate vaccineis indicated in the EU for the prevention of high-grade cervical intraepithelial neoplasia (CINgrades 2 and 3) and cervical cancer causally related to human papillomavirus (HPV) types 16 and 18.5

In May 2007, the candidate vaccine was granted its first license in a major market by the Therapeutic Goods Administration (TGA) of Australia for the prevention of cervical cancer and precancerous lesions caused by human papillomavirus types 16 and 18 for use in females ages 10 to 45 years.[9] This is the first time that a cervical cancer vaccine has been approved with an explicit indication anywhere in the world for women over the age of 26. Subsequent licenses have been granted in other international markets.

GSK submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for its cervical cancer candidate vaccine in March 2007, following earlier regulatory filings with the European Medicines Agency (EMEA) and regulatory filings in Africa, Asiaand Latin America.

Notes to Editors

About cervical cancer

Cervical cancer is the second leading cause of cancer in women, and causes over 270,000 deaths worldwide per year.[10] It occurs when infection with the human papillomavirus becomes persistent and progresses to cancer. Up to 80 per cent of sexually active women will acquire a human papillomavirus infection in their lifetime, with the risk of persistence increasing with age.[11],[12] Approximately 100 types of human papillomavirus have been identified to date[13] and, of these, approximately 15 virus types are considered to cause cervical cancer.[14] Virus types 16 and 18 are responsible for approximately 67 per cent of cervical cancers in Asia.[15]

About GlaxoSmithKline and GlaxoSmithKline Biologicals

In the next five years, GSK expects to launch a number of significant new vaccines to protect against a range of serious diseases.

GlaxoSmithKline â€“ one of the worldâ€™s leading research-based pharmaceutical and healthcare companies â€“ is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For company information, please visit www.gsk.com/media.

GSK Biologicals (GSK Bio), one of the worldâ€™s leading vaccine manufacturers, is headquartered in Rixensart, Belgium, where the majority of GlaxoSmithKlineâ€™s activities in the field of vaccine research, development and production are conducted. GSK Bio employs more than 1,500 scientists, who are devoted to discovering new vaccines and developing more cost-effective and convenient combination products to prevent infections that cause serious medical problems worldwide. In 2006, GSK Bio distributed more than 1.1 billion doses of vaccines to 169 countries in both the developed and the developing world â€“ an average of 3 million doses a day. Of those vaccine doses, approximately 136 million were doses of combination paediatric vaccines which protect the worldâ€™s children from up to six diseases in one vaccine.

PRESS RELEASE: GSK seeks prequalification for Cervarix from the World Health Organization

Maureen Martino — Thu, 04 Oct 2007 12:17:20 -0400

GSK seeks prequalification for Cervarixâ„¢ from the World Health Organization after obtaining marketing approval in Europe

For business and financial press only

Issued â€” Thursday 4 October 2007, London, UK & Rixensart, Belgium

Goal is to speed availability in the developing world

GlaxoSmithKline (GSK) announced today that it has submitted a file on its cervical cancer vaccine, Cervarixâ„¢, to the World Health Organization (WHO) for pre-qualification, following the granting of a marketing authorisation approval by regulatory authorities in Europe on 20 September.

WHO designed the pre-qualification mechanism to speed the delivery of new vaccines to developing countries (and where they are needed most), once the vaccines have received approval from a recognised national regulatory authority. With three opportunities for submission a year, prequalification functions as a public health endorsement of a vaccineâ€™s efficacy, safety and quality and confirms the manufacturerâ€™s ability to fulfil large-scale UN tenders. Products with prequalification status may be used by UN agencies and the GAVI Alliance, as well as mass vaccination programmes across the developing world.

â€œGSK believes that people in developing countries should have rapid access to life-saving vaccines once they are approved,â€ said Jean StÃ©phenne, President and General Manager of GSK Biologicals. â€œBy submitting Cervarix for prequalification as early as possible, we are working to eliminate the historical 15-20 year delay for new vaccines to become available in developing countries. This move is the latest example of GSKâ€™s longstanding partnership with UNICEF and the GAVI Alliance, including our tiered pricing programme, which we pioneered more than 20 years ago.â€

Worldwide a woman dies of cervical cancer every two minutes resulting in more than 270,000 deaths each year.1 85 per cent of deaths from cervical cancer occur in the developing world where, in the absence of regular screening and treatment programmes, it is the leading cause of cancer deaths in women.1

â€œCervical cancer vaccines represent a major medical breakthrough and have the potential to transform womenâ€™s health, particularly in resource-poor countries,â€ said Dr. Nono Simelela from the International Planned Parenthood Federation. â€œPrequalification would help speed access to this important new tool for girls and women across the world at risk for cervical cancer. Along with increased awareness and improvements in screening and treatment, cervical cancer vaccines will help save and improve the lives of millions of women.â€

GSK Biologicals has a long-standing commitment to preventing diseases prevalent in the developing world. As with its other vaccines, GSK will provide its cervical cancer vaccine at preferential prices to low income countries. GSKâ€™s unique business model is designed to ensure availability of its vaccines regardless of where people live. Under tiered pricing, GSK offers low-cost vaccines to major purchasers like UNICEF and the GAVI Alliance as well as individual countries based on their national income, the volume of doses ordered and the length of the contract.

Notes to editors

About CervarixTM

GSK developed Cervarixâ„¢ to protect women from cervical cancer by guarding against the most common cancer-causing forms of the human papillomavirus (HPV). Clinical trials involving almost 30,000 females demonstrated excellent efficacy and immunogenicity data, including:

- Interim data from the largest Phase III cervical cancer vaccine efficacy trial to date2, which demonstrated that â€” based on a post hoc analysis* - the vaccine provides 100 percent protection against precancerous lesions (CIN2+) causally related to human papillomavirus types 16 and 18. These virus types are responsible for 70 per cent of all cervical cancer cases worldwide.3 The interim analysis also indicated that the vaccine is generally well tolerated

- Long-term trial data showing 100 per cent sustained protection for up to 5.5 years after vaccination.4 Duration of protection is particularly important as women may acquire infections throughout their lifetimes

- Data from immunogenicity trials, which indicate that the vaccine is highly immunogenic in a broad age range, inducing high antibody levels in women aged 10-55 years old4,5,6

* In this study of women, including those with other oncogenic HPV infections and low-grade abnormal cytology at entry, there was 90 per cent efficacy against CIN2+ associated with HPV 16/18 DNA in the lesion. Many of the CIN2+ lesions were associated with multiple HPV types. There was 100 per cent efficacy against CIN2+ considered causally related to HPV 16/18 in an additional, post hoc, analysis taking account of the likely causal role of persistence of oncogenic HPV infection prior to lesion development.2

Novel adjuvant system

Cervarixâ„¢is formulated with a novel proprietary adjuvant system called AS04, which is designed to enhance the immune response against cancer-causing virus types.

Published data have shown that the vaccine, formulated with this adjuvant system, induces an immune response of higher magnitude and persistence compared to the same vaccine composition, formulated with conventional aluminium hydroxide adjuvant alone.8

About cervical cancer

Cervical cancer is the second leading cause of cancer in women.9 500,000 new cases of cervical cancer are reported in women each year and projections indicate that, without a dramatic improvement in cervical cancer prevention, there could be over a million new cases each year by 2050.9

Cervical cancer occurs when infection with the human papillomavirus becomes persistent and progresses to cancer. Up to 80 per cent of sexually active women will acquire a human papillomavirus infection in their lifetime, with the risk of persistence increasing with age.10,11

Approximately 100 types of human papillomavirus have been identified to date12 and, of these, approximately 15 virus types are considered to cause cervical cancer.3 Virus types 16 and 18 are responsible for approximately 71.5 per cent of cervical cancers in Europe.3

About GlaxoSmithKline and GlaxoSmithKline Biologicals

In the next five years, GSK expects to launch a number of significant new vaccines to protect against a range of serious diseases.

GlaxoSmithKline - one of the worldâ€™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 company information, please visit www.gsk.com/media.

GSK Bio has one of the largest development pipelines in the vaccine industry. Of the more than 25 vaccine projects in the pipeline, approximately one-third are focused on diseases prevalent in the developing world. These include vaccines for pneumococcal diseases, meningitis, and dengue. GSK Bio is the only company with vaccine development programmes for each of the â€œbig threeâ€ global infectious diseases: HIV/AIDS, malaria, and TB.

In 2006, GSK Bio distributed more than 1.1 billion doses of vaccines to 169 countries. Of these doses, seventy-five percent of these went to the developing world. Approximately 136 million were doses of combination paediatric vaccines which protect the worldâ€™s children from up to six diseases in one vaccine.

Cervarix is a trademark of the GlaxoSmithKline group of companies.