A needle-free vaccine against traveller’s diarhoea may be in the offing.
GlaxoSmithKline Biologicals SA has tied up with Intercell in a strategic alliance to accelerate the development and commercialisation of needle-free, patch-based vaccines including vaccine for travellers’ diarrhoea (TD).
Intercell’s investigational travellers’ diarrhoea (TD) vaccine is currently in Phase III stage.
Intercell’s investigational vaccine against travellers’ diarrhoea (TD) is being studied in 1,800 subjects travelling from Europe to Mexico and Guatemala. If approved, it will be the first vaccine delivered with a patch and the first to prevent TD.
The late-stage TD vaccine is based on a needle-free vaccine patch technology and is designed to confer protection against the most prevalent causative agents of diarrhoeal diseases.
Analysis of a Phase II field study of 170 travellers verified that the vaccine patch reduced the risk of moderate to severe TD by 75 percent.
The positive results from the field study were published in The Lancet in June 2008. In addition, clinical testing has shown a strong immune response directed against ETEC bacteria.
Intercell’s other candidate vaccines include an investigational single application pandemic influenza vaccine which is in Phase II.
GSK and Intercell’s candidate will use the patch technology for other vaccines in GSK’s portfolio.
Under the terms of the agreement, GSK will make an up-front cash contribution of € 33.6 (£30) million, in addition to an equity investment of up to € 84 (£75) million through a staggered shareholding purchase option of up to 5 % in Intercell.
“GSK has an extensive portfolio of vaccines and we believe needle-free vaccination could offer benefits such as simplified administration and increased compliance.” said Jean Stephenne, President of GSK Biologicals.
This new partnership is combining the forces of Intercell’s innovative needle-free vaccination programme and technologies with a vaccine leader’s strength in development and commercialisation.
Each year, approximately 20 million international travellers develop travellers’ diarrhoea while visiting endemic areas in Asia, Africa and South America. Currently, there is no vaccine available to address this medical need.
GSK and Intercell will collaborate on the TD Vaccine Patch, currently in phase III, to commercialise this vaccine once it has gained regulatory approval.
The agreement will also include a collaboration between the two companies to further develop and co-market an innovative pandemic influenza vaccination approach.
The patch technology is a new way of vaccine delivery that could make vaccines easier to administer, faster to deliver, and could result in lower or fewer doses. The vaccine patch is a new and needle free delivery technology which can be used to: Enhance the effect of injected vaccines: Vaccine Enhancement Patch (VE Patch) and develop new vaccines which require transcutaneous administration because the antigen can not be delivered safely through other routes of administration.
Compared with standard immunisation via needles, the patch technology could offer certain benefits, e.g. easy administration and direct delivery of the antigen and adjuvant to the immune system through natural defence pathway, which could make vaccination more efficient.
In studies, the patch was shown to boost cellular immunity to a diverse range of antigens and to stimulate both B-cell and T-cell responses. It contains the heat labile enterotoxin from E. coli (LT), one of the most potent stimulators of the immune system.
GlaxoSmithKline is one of the world’s leading research-based pharmaceutical and healthcare companies.
Intercell AG is an innovative biotechnology company that develops novel vaccines for the prevention and treatment of infectious diseases. Intercell’s vaccine to prevent Japanese Encephalitis is the Company’s first product on the market.
Intercell”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.
Intercel’s ‘s pipeline of investigational products includes a Travelers’ Diarrhoea Vaccine Patch (Phase III), 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.