Intercell Supports the Japanese Encephalitis Vaccination Recommendations of CDC's Advisory Committee on Immunization Practices
- Expanded Guidelines to include availability of IXIARO(R) vaccine for Japanese Encephalitis
- IXIARO now available in the U.S. for travelers to Asia, military personnel, others at high risk regardless of the length of visit
ATLANTA, June 24 /PRNewswire/ -- Intercell AG (VSE: ICLL) today announced that the U.S. Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) voted to update its previous recommendations and include IXIARO, a new Japanese Encephalitis (JE) vaccine for travelers to countries in Asia where the disease is endemic, as well as Americans living in such high-risk areas.
ACIP made significant changes to their previous Japanese Encephalitis recommendations, last updated in 1993, noting that many more travelers are now visiting areas where the disease is endemic. In addition to recognizing the recent licensure of IXIARO, the committee's expanded recommendations urged clinicians to consider vaccinating travelers visiting endemic areas during the transmission season, even those on short-term visits, if they plan to spend a substantial amount of time outdoors. The panel also concluded that IXIARO, which is derived from a well-established cell line and does not contain stabilizers or preservatives, has a lower risk of vaccine-associated adverse events than older Japanese Encephalitis vaccines.
IXIARO received marketing approval from the U.S. Food and Drug Administration on March 30, 2009 on the basis of studies that showed the vaccine is highly immunogenic after only two doses. IXIARO has been shown to stimulate a long-lasting immune response and to be well tolerated. It is the only currently manufactured Japanese Encephalitis vaccine available in the United States. IXIARO was developed by Intercell AG; the rights to market and distribute the vaccine to the private sector in the United States are held by Novartis Vaccines.
"The consequences of contracting this disease can be devastating due to the high morbidity and mortality associated with the disease, making IXIARO a crucial preventive tool for those spending time in endemic areas. It is gratifying that the ACIP committee of the CDC has chosen to broaden its recommendations and to recognize the benefits of IXIARO," said Gerd Zettlmeissl, Chief Executive Officer of Intercell. "This underscores our commitment to serving the needs of the travelers' and of the military market and developing vaccines to address unmet needs."
The ACIP consists of 15 experts in fields associated with immunization who have been selected by the Secretary of the U.S. Department of Health and Human Services to provide advice and guidance on the control of vaccine-preventable diseases. ACIP develops written recommendations for the routine administration of vaccines to children and adults in the civilian population. The ACIP is the only entity in the federal government that makes such recommendations.
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 misdiagnosis). 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 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 of adults against the Japanese Encephalitis virus. The total development time for this vaccine was 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 IXIARO found that the vaccine demonstrated immunogenicity against Japanese Encephalitis and an overall clinical safety profile similar to the control arm, 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 the control arm.
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 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 (Vaccine Patch, Vaccine Enhancement Patch). Based on these technologies, Intercell has strategic partnerships with a number of global pharmaceutical companies, including Novartis, Merck & Co., Inc., Wyeth, and Sanofi Pasteur.
The Company's pipeline includes a Travelers' Diarrhea Vaccine Patch (Phase III in preparation), a Pseudomonas vaccine candidate (Phase II), a Vaccine Enhancement Patch to prevent Pandemic Influenza in combination with an injected vaccine (Phase II), a vaccine program for S. aureus, which is being developed with Merck & Co., Inc. (Phase II/III), as well as a vaccine candidate for Pneumococcus (Phase I). In addition, three other products focused on infectious diseases are in pre-clinical development.
Intercell is listed on the Vienna stock exchange under the symbol "ICLL" (U.S. level one ADR symbol "INRLY").
For more information, please visit: 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.