Navigation Links
Intercell Announces European Approval of New Vaccine, IXIARO(R), to Prevent Japanese Encephalitis

-- European Commission grants marketing authorization for Intercell's IXIARO, the first licensed vaccine against Japanese Encephalitis for travelers and military personnel in Europe

-- This final decision follows the positive opinion from European Committee for Human Medicinal Products (CHMP) in December 2008

VIENNA, April 2 /PRNewswire/ -- Intercell AG (VSE: ICLL) today announced that its new vaccine to prevent Japanese Encephalitis, IXIARO(R), has been approved by the European Commission. The approval by the European Union, the first for a vaccine to prevent the disease, provides formal market authorization in all 27 member states as well as Norway and Iceland.

"The European approval of IXIARO marks a crucial milestone in Intercell's evolution as one of the leading independent vaccine development companies with a vaccine marketed," said Intercell's Chief Executive Officer Gerd Zettlmeissl. "For the first time, both civilians and members of the military across Europe will have access to a safe and effective vaccine against this devastating and endemic disease found throughout Asia, which kills as many as one in three of the people it strikes."

This decision follows the positive opinion from European Committee for Human Medicinal Products (CHMP) in December 2008. Novartis AG holds marketing and distribution rights for IXIARO, in the United States, Europe, Japan, Korea and certain other markets in Asia and Latin America.

A final assessment by the European COMP (Committee for Orphan Medicinal Products) focused on updated information indicating that the expected potential European vaccine market for IXIARO is significantly higher than initially evaluated, and, therefore, the vaccine will not have an orphan drug designation.

Intercell's product is a purified, inactivated vaccine for active immunization against infections with Japanese Encephalitis virus. The new vaccine is manufactured in Intercell's proprietary manufacturing facility in Scotland and is prepared using tissue culture rather than live organisms.

In addition to the European approval, Intercell's vaccine was also approved by the Australian Therapeutic Goods Administration (TGA) for use in Australia, and the U.S. Food and Drug Administration for the U.S. market.

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 (both probably an underestimate due to underreporting and other factors). Up to 50 percent of survivors have persistent neurological sequelae. Japanese Encephalitis is the leading cause of viral neurological disease and disability in Asia and the most important viral encephalitis in Asia. The disease is most common in several developing countries in Asia, including India and China. As there is no specific treatment for JE, health care experts recommend vaccination as the only highly effective protection for the millions of travelers and military personnel who live in or travel to areas where the virus circulates.


Intercell's novel Japanese Encephalitis vaccine is a purified, inactivated vaccine for active immunization against the Japanese Encephalitis virus. The total development time of this vaccine took more than 10 years. The vaccine was developed under a Collaborative Research and Development Agreement with the Walter Reed Army Institute of Research, a biomedical research laboratory for the U.S. Department of Defense.

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 December 2007:

  • 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 Japanese Encephalitis vaccine had a more favorable local tolerability profile in the head-to-head study with JE-VAX(R).

About Intercell AG

Intercell AG is an innovative 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 Vienna stock exchange under the symbol "ICLL".

For more information, please visit:

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
Copyright©2009 PR Newswire.
All rights reserved

Related biology technology :

1. Intercell to Host Conference Call and Webcast Today on FDA Approval of IXIARO(R) Japanese Encephalitis Vaccine
2. Intercell Announces FDA Approval of IXIARO(R), a Novel Vaccine to Prevent Japanese Encephalitis
3. Australian Authorities (TGA) First to Grant Final Product Approval for Intercells Vaccine to Prevent Japanese Encephalitis
4. Iomai Stockholders Approve Merger With Intercell Subsidiary
5. Iomai, Intercell Chief Scientific Officers to Speak on Future of Vaccines at BIO International Convention Today
6. Nuevolution Announces Progress in Its Collaboration With Merck & Co. Inc.
7. China Biologic Products Announces Strong 2008 Results
8. Senetek PLC Announces New Investor Communication Hotline
9. NovaBay Pharmaceuticals, Inc. Announces Fourth Quarter and Full Year 2008 Financial Results
10. ACM Global Central Lab Announces Partnership with Chindexs United Family Hospitals in China
11. Novavax Announces New Capital Infusion Through a Strategic Alliance with Cadila Pharmaceuticals of India
Post Your Comments:
(Date:11/24/2015)... Nov. 24, 2015  Asia-Pacific (APAC) holds the ... (CRO) market. The trend of outsourcing to low-cost ... but higher volume share for the region in ... however, margins in the CRO industry will improve. ... ( ), finds that the market ...
(Date:11/24/2015)... Nov. 24, 2015 Halozyme Therapeutics, Inc. (NASDAQ: HALO ... New York on Wednesday, December 2 at ... , president and CEO, will provide a corporate overview. ... at 1:00 p.m. ET/10:00 a.m. PT . ... will provide a corporate overview. --> th Annual ...
(Date:11/24/2015)... ... November 24, 2015 , ... International Society ... one of the premier annual events for pharmaceutical manufacturing: 2015 Annual Meeting. The ... where ISPE hosted the largest number of attendees in more than a decade. ...
(Date:11/24/2015)... , November 24, 2015 ... market research report "Oligonucleotide Synthesis Market by Product & ... Gene Synthesis, Diagnostic, DNA, RNAi), End-User (Research, Pharmaceutical & ... by MarketsandMarkets, the market is expected to reach USD ... 2015, at a CAGR of 10.1% during the forecast ...
Breaking Biology Technology:
(Date:11/16/2015)... Calif. , Nov 16, 2015  Synaptics ... of human interface solutions, today announced expansion of ... TouchView ™ touch controller and display driver ... revolution of smartphones. These new TDDI products add ... TD4100 (HD resolution), TD4302 (WQHD resolution), and TD4322 ...
(Date:11/12/2015)... , Nov. 11, 2015   Growing ... reliable analytical tools has been paving the way ... qualitative determination of discrete analytes in clinical, agricultural, ... are being predominantly used in medical applications, however, ... environmental sectors due to continuous emphasis on improving ...
(Date:11/10/2015)... 2015 About signature verification ... to identify and verify the identity of an ... the secure and accurate method of authentication and ... individual because each individual,s signature is highly unique. ... dynamic signature of an individual is compared and ...
Breaking Biology News(10 mins):