Corporate Banner
Satellite Banner
Biologics & Bioprocessing
Scientific Community
 
Become a Member | Sign in
Home>News>This Article
  News
Return

Intercell Receives CHMP Positive Opinion for the Pediatric Indication of IXIARO®

Published: Thursday, December 20, 2012
Last Updated: Wednesday, December 19, 2012
Bookmark and Share
Final approval is expected in February or March 2013.

Intercell AG has announced that the CHMP of the European Medicines Agency (EMA) has come to a positive opinion on the Marketing Authorization for IXIARO® in children, a vaccine to protect against Japanese Encephalitis (JE).

The final decision (approval) by the European Commission is expected in February or March 2013.

Intercell has submitted applications for the approval of a JE vaccine pediatric label extension to major regulatory agencies in late Q2 2012 based on data from a Phase III clinical study conducted in the Philippines and favorable interim data from a second Phase III trial in EU, US and Australia.

In both studies the JE vaccine showed to be highly immunogenic in children aged 2 months to <18 years with a safety profile comparable to pediatric vaccines licensed for other diseases.

“We are very pleased about the positive CHMP opinion on the pediatric indication for our JE vaccine. This will be the first time European travelers of all ages can be protected against this dreadful disease with a licensed vaccine", states Thomas Lingelbach, Chief Executive Officer of Intercell AG.

Following the approval and launch of Intercell's vaccine against Japanese Encephalitis for adult travelers and military personnel in Europe, the United States, Canada, Hong Kong, Singapore, Israel (IXIARO®) and Australia and New Zealand (JESPECT®), the development of a vaccine to protect children traveling to endemic areas from Japanese Encephalitis has been a major goal of the Company.

The vaccine to prevent Japanese Encephalitis (JE) is Intercell’s first product on the market. This is a next-generation vaccine used to help prevent infection with the JE virus, and has been licensed in more than 30 countries.

The vaccine is a purified, inactivated vaccine and causes the body to produce its own protection (antibodies) against this disease.

Upon approval of the new indication for the pediatric age segment in the EU, the vaccine will offer protection against JE for adults and children aged 2 months and above who travel to, or live in, endemic areas.

In the U.S. the vaccine is currently licensed for those above 17 years of age, and in Canada, Australia and New Zealand it is licensed for persons above 18 years of age.

In the U.S. the pediatric label extension is currently under review by the FDA.

The vaccine is manufactured by Intercell AG’s wholly-owned subsidiary Intercell Biomedical Ltd. at our cGMP facility in Livingston, Scotland.


Further Information
Access to this exclusive content is for Technology Networks Premium members only.

Join Technology Networks Premium for free access to:

  • Exclusive articles
  • Presentations from international conferences
  • Over 2,500+ scientific posters on ePosters
  • More than 3,700+ scientific videos on LabTube
  • 35 community eNewsletters


Sign In



Forgotten your details? Click Here
If you are not a member you can join here

*Please note: By logging into TechnologyNetworks.com you agree to accept the use of cookies. To find out more about the cookies we use and how to delete them, see our privacy policy.

Related Content

Intercell and Vivalis Provide Update on the Progress Towards Intended Merger
Company’s general meetings have been convened and will take place on 27 February 2013 and 4 March 2013 respectively.
Wednesday, January 30, 2013
Thomas Szucs Elected New Chairman of Intercell’s Supervisory Board
Thomas Szucs takes over the function from Michel Gréco, who resigned from the role but still remains a member of the Supervisory Board.
Tuesday, January 03, 2012
Intercell Receives Positive Scientific Advice from EMA for Pseudomonas Vaccine Phase II/III-Study
First interim data are expected mid 2013.
Monday, October 17, 2011
Successful Completion of Investigational Japanese Encephalitis Vaccine Study
Intercell AG and its partner Biological E. Ltd. announce the successful completion of a pediatric Phase II/III study for the vaccine to protect children from Japanese Encephalitis (JE).
Saturday, September 17, 2011
Intercell Reports Positive Results From Its Phase II Pseudomonas Aeruginosa Investigational Vaccine Study
Intercell AG today announced results from a Phase II clinical trial involving the company's investigational nosocomial vaccine candidate (IC43) against infections with the bacterium Pseudomonas aeruginosa, a leading cause of hospital-acquired infections with increasing antibiotic resistance and hence a very high unmet medical need.
Monday, October 25, 2010
Scientific News
Less May Be More in Slowing Cholera Epidemics
Mathematical model shows more cases may be prevented and more lives saved when using one dose of cholera vaccine instead of recommended two doses.
NIH Launches Human RSV Study
Study aims to understand infection in healthy adults to aid development of RSV medicines, vaccines.
Flu Remedies Help Combat E. coli Bacteria
Physiologists from the University of Zurich have now discovered why the intestinal bacterium Escherichia coli (E. coli) multiplies heavily and has an inflammatory effect.
'Fountain of Youth' Protein Points to Possible Human Health Benefit
Patients with higher blood levels of growth factor have lower risk of cardiovascular problems.
Lemon Juice and Human Norovirus
Citric acid may prevent the highly contagious norovirus from infecting humans, scientists discovered from the German Cancer Research Center.
Study Backs Flu Vaccinations for Elderly
Brown University researchers found vaccines well matched to the year’s flu strain significantly reduce deaths and hospitalizations compared to when the match is poor, suggesting that vaccination indeed makes a difference.
Inciting an Immune Attack on Cancer Cells
A new minimally invasive vaccine that combines cancer cells and immune-enhancing factors could be used clinically to launch a destructive attack on tumors.
Protein Found to Play a Key Role in Blocking Pathogen Survival
Calprotectin fends off microbial invaders by limiting access to iron, an important nutrient.
Major Advance Toward More Effective, Long-Lasting Flu Vaccine
Collaboration shows vaccine candidate can produce powerful ‘broadly neutralizing antibodies’ in animal models.
Immune System: Help for Killer Cells
A study from the University of Bonn may show the way to more effective vaccines.
SELECTBIO

Skyscraper Banner
Go to LabTube
Go to eposters
 
Access to the latest scientific news
Exclusive articles
Upload and share your posters on ePosters
Latest presentations and webinars
View a library of 1,800+ scientific and medical posters
2,500+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
3,700+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FREE!