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Intercell Announces FDA Approval of IXIARO®, a Vaccine against Japanese Encephalitis – A Successful Collaboration with the U.S. Army
- U.S. FDA (Food and Drug Administration) approves Intercell's first marketed product, a new vaccine against Japanese Encephalitis for adult travelers and military personnel
- Success of Intercell's new JE vaccine is a result of an excellent collaboration between Intercell and the Walter Reed Army Institute of Research in the U.S.
- Supply contract for IXIARO with the U.S. military, to be concluded in the near future, forms the basis for distribution of the vaccine to the U.S military
Vienna, Austria, March 31, 2009 – Intercell AG (VSE: ICLL) today announced FDA approval of its new vaccine, IXIARO, for the prevention of Japanese Encephalitis (JE), which now builds the basis for the future distribution of the vaccine to the U.S. military. The Defense Logistics Agency (DLA), United States Department of Defense, already posted a Request for Proposal (RFP) for purchase of JE vaccine in August 2008. As JE is a serious and growing public health threat in Asia, the DLA intends to enter into a contract to purchase supplies of JE vaccine for use with military personnel who are deployed to affected countries.
"With the approval of IXIARO, Americans – both civilians and military personnel – will have an efficacious and safe vaccine to protect themselves from the devastating effects of Japanese Encephalitis. JE is a deadly disease found mainly in Asia that kills approximately one-third of those persons who contract it and leaves one-half of survivors with permanent brain damage. As there is no specific treatment for JE, health care experts recommend vaccination as the best protection for the millions of travelers and military personnel who live in or travel to areas where the virus circulates," said Intercell's Chief Executive Officer, Gerd Zettlmeissl. "The timing of this FDA approval of IXIARO is good news because production has been halted and inventories are almost exhausted for the only other JE vaccine licensed in the United States today."
IXIARO was developed for over 10 years under a Collaborative Research and Development Agreement (CRADA) with the Walter Reed Army Institute of Research (WRAIR). "The expert scientists at WRAIR made a significant contribution towards development of IXIARO and Intercell is very appreciative of this outstanding collaboration. The FDA approval of IXIARO is an excellent example of what can be achieved when industry and government work together towards an important common goal. Intercell looks forward to supplying this novel vaccine to the U.S military for use in their JE immunization program," added Zettlmeissl.
"The U.S. Department of Defense (DoD) welcomes the news that IXIARO has now been approved by FDA," stated LTC(P) Wayne Hachey, Director of Preventive Medicine in the Office of the Deputy Assistant Secretary of Defense for Force Health Protection and Readiness. "The Department has been committed to protecting its Service members from this serious disease since the threat was first recognized during World War II", Hachey said. "DoD researchers developed the initial vaccine against Japanese Encephalitis (JE) and are responsible for much of our understanding regarding the effectiveness and safety of that vaccine.
"Recognizing that a replacement vaccine would be required," Hachey explained, "DoD researchers were again at the forefront of the JE vaccine development that eventually led to IXIARO. Through a decade-long successful collaboration between DoD and Intercell, we now have an effective vaccine that early indications predict both improved safety and convenience for our Service members."
IXIARO is a purified, inactivated product for active immunization against viral infections of Japanese Encephalitis. IXIARO is manufactured at Intercell’s proprietary manufacturing facility in Scotland and is prepared using modern tissue culture rather than live organisms.
Intercell will directly distribute and market IXIARO to the U.S. military, while such functions will be handled by Novartis Vaccines USA to the private market.
About Japanese Encephalitis
Japanese Encephalitis is a mosquito-borne infection that strikes approximately 50,000 persons per year and causes 15,000 deaths (both probably an underestimate due to underreporting and other factors). The disease is most common in several developing countries in Asia, including India and China. JE causes death in one out of every three people with overt encephalitis and one-half of survivors develop permanent brain damage. No treatment is currently available for JE and only vaccination effectively prevents the disease. Though another JE vaccine was available in the past, use of that product was limited by reports of adverse reactions; furthermore, this vaccine is no longer being produced for the United States market and supplies will soon be exhausted.
About IXIARO
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®.
- 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®.
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