DJ Successful Collaboration between U.S. Army and Intercell Towards a Novel Vaccine Against Japanese Encephalitis for Military and Travelers

 
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Washington, DC and Vienna, Austria, December 20, 2007 - Today, December 20, 2007 
Intercell AG (VSE, "ICLL") announced the finalization of the submission of a 
Biologics License Application (BLA) with the U.S. Food and Drug Administration 
(FDA) for Intercell's investigational Japanese Encephalitis (JE) vaccine. 
 
Intercell's JE vaccine was developed for over 10 years under a Collaborative 
Research and Development Agreement (CRADA) with the Walter Reed Army Institute 
of Research (WRAIR). As JE is a significant and serious public health threat in 
Asia, the initial target for use of Intercell's vaccine will be military 
personnel and adult civilian travelers who are deployed to or visit affected 
countries, including India, China, and Southeast / Southwest Asia. Assuming 
review and approval by the regulatory authorities in a timely manner, Intercell 
currently anticipates first market launch of its JE vaccine during second half 
of 2008. 
 
"The Army has enjoyed an excellent and successful collaboration with Intercell 
for several years towards development of this important JE vaccine," said 
William Howell, Acting Director of USAMRMC.  "We are extremely pleased that 
Intercell's JE vaccine has progressed to the point of completion of the BLA 
submission process.  Furthermore, the timing of this FDA submission is good news 
because production has been halted for the only JE vaccine licensed in the 
United States today. The Army is hopeful that Intercell's JE vaccine will be FDA 
approved and available for military use in the near future." 
 
"Intercell is greatly appreciative of the expert technical support the Company 
has received from the Army during development," noted Gerd Zettlmeissl, Chief 
Executive Officer of Intercell. 
 
"We would like to especially thank the many dedicated scientists at WRAIR for 
their outstanding efforts.  The success of our new JE vaccine is an excellent 
example what can be achieved when industry and government work together towards 
an important common goal.  Intercell looks forward to the time when we will 
begin supplying the novel product for use in the military's JE immunization 
program." 
 
About Intercell's investigational JE vaccine 
 
Intercell's novel investigational JE vaccine is a purified, inactivated vaccine 
for active immunization against the Japanese Encephalitis virus. With over 3 
billion people living in endemic areas, Japanese Encephalitis, a mosquito-borne 
flaviviral infection, is the leading cause of childhood encephalitis and viral 
encephalitis in Asia. 
 
In successfully concluded pivotal non-inferiority Phase III trials, Intercell's 
Japanese Encephalitis vaccine demonstrated a favorable safety and immunogenicity 
profile: 
 
» The immunogenicity was comparable to that of the U.S. licensed product, JE- 
  VAX® 
» It demonstrated an overall clinical safety profile similar to placebo 
» Further, Intercell's JE vaccine showed an excellent local tolerability 
  profile in this head-to-head study with JE-VAX® 
 
Intercell's novel investigational JE vaccine, manufactured in the company's 
proprietary manufacturing facility, is prepared using tissue culture rather than 
live organisms and does not contain any stabilizers such as gelatin or 
preservatives in its formulation. 
 
On June 13, 2006, Novartis and Intercell announced that the companies had 
reached an agreement for Novartis to acquire marketing and distribution rights 
for Intercell's Japanese Encephalitis Virus Vaccine in the United States, Europe 
and certain other markets in Asia and Latin America. 
 
About U.S. Army Medical Research and Material Command 
 
The US Army Medical Research and Materiel Command (USAMRMC) has the 
accountability to provide medical materiel and information in support of the 
Army's deployed force.  Infectious diseases are of significant interest as 
endemic diseases in areas of potential deployment act as threats to military 
readiness.  Historical data clearly shows that infectious disease remains one of 
the primary sources of hospitalization for soldiers during times of war or 
military operations.  In response, the Walter Reed Army Institute of Research, a 
subordinate command within USAMRMC, has worked vaccine constructs to several 
diseases found throughout the world, to include Japanese Encephalitis.  The 
USAMRMC is pleased that their initial work has led to the maturation of the 
technology into the current vaccine being submitted for licensure.  With a 
successful approval of the submission, the services will again have a reliable 
source of vaccine for their service members. 
 
 
end of announcement                               euro adhoc 
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(END) Dow Jones Newswires

December 20, 2007 08:22 ET (13:22 GMT)