Successful Collaboration between US Army and Intercell Towards a Novel Vaccine Against JE
- Category: Vaccines
- Published on Friday, 21 December 2007 09:12
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Successful Collaboration between U.S. Army and Intercell Towards a Novel Vaccine Against Japanese Encephalitis for Military and Travelers
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.