Australian Authorities (TGA) First to Grant Final Product Approval for Intercell's Vaccine to Prevent Japanese Encephalitis
Posted on: Friday, 23 January 2009, 09:47 CST
This decision of the Australian authorities represents the first
regulatory approval for the vaccine in any country. Intercell has been
successfully advancing parallel regulatory processes in all key markets for
travelers and military personnel with an imminent product approval in the U.S.
Following the CHMP positive opinion of the European Medicines Agency (EMEA)
obtained in
"We are very pleased that all approval processes for our novel Japanese
Encephalitis vaccine have proceeded in line with our planned timelines. We are
now moving forward to bring this important product to both travelers and
military personnel in early 2009," states
Japanese Encephalitis is a deadly disease that kills as many as 30% of those who manifest the disease. Japanese Encephalitis is only becoming a larger risk for travelers. There is increasing travel to rural areas where the disease is more common, and climate change is extending the range of disease-carrying mosquitoes.
Intercell's vaccine will be the only registered JE-vaccine available in
the Australian market and will be distributed and marketed by CSL Biotherapies
Pty Ltd., which has the exclusive right for marketing and distribution of the
novel cell culture-based vaccine in
Intercell's vaccine is a purified, inactivated product for active
immunization against viral infections of Japanese Encephalitis. The vaccine is
manufactured in Intercell's proprietary manufacturing facility in
About Japanese Encephalitis
Japanese Encephalitis is a mosquito-borne infection that strikes 30,000 to
50,000 individuals a year, causing 10,000 to 15,000 deaths. Up to 50% of
survivors have persistent neurological sequelae. Japanese Encephalitis is the
leading cause of viral neurological disease and disability in
About Intercell's JE vaccine
Intercell's novel JE vaccine is a purified, inactivated vaccine for active immunization against the Japanese Encephalitis virus. The vaccine was developed for over 10 years under a Collaborative Research and Development Agreement (CRADA) with the Walter Reed Army Institute of Research (WRAIR).
Intercell's Phase III trials for the vaccine found that the vaccine
demonstrated excellent immunogenicity against Japanese Encephalitis and an
overall clinical safety profile similar to placebo combined with an excellent
local tolerability profile. These data were published in The Lancet in
-- The immunogenicity was comparable to that of the U.S. licensed product, JE-VAX(R)
-- Intercell's vaccine demonstrated an overall clinical safety profile similar to placebo
-- Further, Intercell's JE vaccine had an excellent local tolerability profile in the head-to-head study with JE-VAX(R)
In
About Intercell AG
Intercell AG is a growing biotechnology company that designs and develops novel vaccines for the prevention and treatment of infectious diseases with substantial unmet medical needs. Intercell's vaccine to prevent Japanese Encephalitis is the company's first product on the market.
The Company's technology platforms include an antigen-discovery system, adjuvants and a novel patch-based delivery system. Based on these technologies, Intercell has strategic partnerships with a number of global pharmaceutical companies, including Novartis, Merck & Co., Inc., Wyeth, Sanofi Pasteur, Kyowa Hakko Kirin and the Statens Serum Institut.
The Company's development pipeline includes Phase II vaccine programs for Pseudomonas (in-house development) and S. aureus, which is being developed with Merck & Co. Inc. The Company's novel Travelers' Diarrhea vaccine patch will enter Phase III testing in 2009. Intercell is also in clinical trials of a vaccine enhancement patch with injected Pandemic Influenza vaccines (one shot plus patch). In addition, four other products focused on infectious diseases are in pre-clinical development.
Intercell is listed on the
For more information, please visit: http://www.intercell.com
This communication expressly or implicitly contains certain forward-looking statements concerning Intercell AG and its business. Such statements involve certain known and unknown risks, uncertainties and other factors which could cause the actual results, financial condition, performance or achievements of Intercell AG to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Intercell AG is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.
SOURCE Intercell AG
Source: PR Newswire
Related Articles
- Intercell Supports the Japanese Encephalitis Vaccination Recommendations of CDC's Advisory Committee on Immunization Practices
- Intercell Announces FDA Approval of IXIARO(R), a Vaccine Against Japanese Encephalitis
- USD 12.5 m Funding for the Development of Intercell's Vaccine Patch System for Pandemic Influenza From U.S. Department of Health and Human Services (HHS)
- Metabasis Announces Preliminary Safety and Efficacy Results From an Ongoing Phase 1b Clinical Trial for MB07811, Its Novel Product Candidate for the Treatment of Hyperlipidemia
- FDA Approves Novel Drug AIDS Patients
- Hutchinson Center Establishes New Vaccine and Infectious Disease Institute
- Bioniche E. Coli O157:H7 Vaccine Discussed at 4th International Conference on Vaccines for Enteric Diseases
- Alternative Technology Adds Novell Products to Its GSA Schedule; Novell Security and Identity Solutions Are Now Available to Government Sectors on Alternative Technology's GSA Schedule
- FDA Approves POSILAC(R) Production at Monsanto's Augusta Facility
 |
 |
User Comments (0)
RSS Feeds