ICLL receives manufacturer's licence for future commercial manufacturing of its JE vaccine
- Category: Vaccines
- Published on Wednesday, 16 January 2008 23:59
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Intercell Receives Manufacturer’s Licence for Future Commercial Manufacturing of its Vaccine Against Japanese Encephalitis
VIENNA, Austria | January 16, 2008 | Intercell AG (VSE: ICLL) announced today that its fully owned manufacturing site in Livingston, Scotland (Intercell Biomedical Ltd.), has been granted the Manufacturer’s Licence for the commercial manufacturing of its vaccine against Japanese Encephalitis. The issuance of the license is following a GMP (Good Manufacturing Practice) inspection performed by the Medicines and Healthcare products Regulatory Agency (MHRA).
The Manufacturer’s Licence is required to support the Marketing Authorization Application (MAA) process in Europe which is being coordinated by the European Medicines Agency (EMEA) and represents the basis for future product release and export to the US.
"The issuance of the Commercial Manufacturer’s Licence is a key achievement on Intercell´s path to bringing our new investigational Japanese Encephalitis vaccine onto the market and should allow us to produce a sufficient launch stock for product approvals in the respective locations," states Gerd Zettlmeissl, Intercell´s Chief Executive Officer.
"Receiving the Manufacturer’s Licence validates our ongoing commitment to focus on quality compliance and execution for our future commercial supplies," says Thomas Lingelbach, Intercell´s Chief Operating Officer.
Intercell expects the pre-approval inspection by the US FDA (Food and Drug Administration) in support of the US licensure process within the forthcoming months.
About Intercell’s investigational JE vaccine (IC51)
Intercell´s novel investigational JE vaccine (IC51) 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. The JE virus remains virulent in this region and has recently spread to countries not previous affected.
In successfully concluded pivotal Phase III trials, Intercell’s IC51 vaccine has demonstrated a favorable safety and immunogenicity profile:
-- The immunogenicity of IC51 was at least as good as the U.S. licensed product, JE-VAX®
-- IC51 demonstrated an overall clinical safety profile similar to placebo
-- Further, IC51 showed an excellent local tolerability profile in this head-to-head study with JE-VAX®
Intercell’s novel JE vaccine is produced using tissue culture rather than live organisms and does not contain any stabilizers such as gelatin or preservatives in its formulation.
Novartis will market and distribute Intercell’s Japanese Encephalitis virus vaccine in the United States, Europe and certain other markets in Asia and Latin America. CSL is Intercell’s marketing and distribution partner in Australia.
About Intercell Biomedical Ltd. (Livingston, Scotland)
In 2004, Intercell acquired a manufacturing plant in Livingston, Scotland, which has enabled the Company to gain in-house GMP manufacturing capabilities for its Japanese encephalitis vaccine and to manufacture the investigational product used in the Phase III clinical trials. With major investments in the last years, the Company has further increased capacities and established a state-of the art, GMP commercial manufacturing facility to support the future supplies of its Japanese encephalitis vaccine. Besides the fully dedicated and further expandable manufacturing facility, the Livingston site has also separate development and clinical manufacturing capacities.