VIENNA, March 2 /PRNewswire-FirstCall/ -- Today, the biotech-vaccine company Intercell AG (VSE: ICLL) announced its financial results for Q4 and the preliminary results for the full financial year 2009, and presented an update on the Company’s development programs.
IXIARO(R)/JESPECT(R) - Foundation for further growth
Global marketing and sales efforts for IXIARO(R)/JESPECT(R) by Intercell’s partners to increase awareness and vaccination recommendations are the basis for growing product uptake in 2010. According to current plans, product sales are expected to increase as of Q2 2010. Product supplies to marketing and distribution partners for the main travel season are expected to partially shift from Q1 to Q2 2010 due to lot release timing for European markets.
TD Vaccine Patch - First-ever patch vaccine in Phase III and basis for patch collaboration with GSK
With GSK as its future marketing partner, Intercell is pushing its development efforts for the investigational Travelers’ Diarrhea (TD) Vaccine Patch towards licensure. The vaccine candidate targets an indication that affects approximately 20 million international travelers annually and for which no vaccine is currently available. The TD Vaccine Patch is presently being investigated in a randomized, placebo-controlled Phase III pivotal efficacy study of 1,800 travelers from Europe to Mexico and Guatemala. In addition, a Phase II placebo-controlled pilot-efficacy trial was launched in 800 subjects from the UK and Germany traveling to India as well as a recently initiated Phase II supportive safety study in healthy U.S. volunteers.
Intercell and GSK will continue developing the single application Pandemic Influenza Vaccine Patch system that consists of the VE Patch administered in conjunction with GSK’s injected Pandemic Influenza vaccine. Intercell’s VE Patch contains the heat-labile enterotoxin (LT) from E. coli, a potent stimulator of the immune system. Because LT is able to boost the effectiveness of an injectable vaccine, Intercell believes that the VE Patch may improve the efficacy of numerous vaccines for which increased immunogenicity, decreased antigen doses or fewer immunizations are desired.
Enrollment in this study has concluded and the serological analysis is under way. The availability of data has shifted to Q2 2010 due to broader than expected validation activities related to this analysis.
Intercell expects important data from two ongoing late-stage vaccine candidates against hospital-acquired infections during 2010. If successful, we expect the Staphylococcus aureus vaccine candidate (partnered with Merck & Co., Inc.) and our Pseudomonas aeruginosa vaccine candidate to significantly contribute to the prevention of these conditions if adults and children are vaccinated on, or before, admittance to hospital.
Pseudomonas aeruginosa vaccine: Intercell’s vaccine candidate against the nosocomial infection, Pseudomonas aeruginosa, is currently being investigated in a 400-patient Phase II clinical trial. Immunogenicity and safety are being examined and first indications for the vaccine’s efficacy are expected.
Additional candidate vaccines with high medical need progressing in development
The development of Intercell’s Streptococcus pneumoniae vaccine is supported by PATH (Program for Appropriate Technology in Health), a U.S.-based non-profit organization dedicated to finding solutions for global health.
Tuberculosis vaccine: Phase I clinical programs are proceeding according to plan. These programs are based on a partnership between Intercell, Statens Serum Institut, sanofi-aventis, and the AERAS Global Tuberculosis Foundation. Further clinical data is expected during 2010.
The full report can be downloaded at http://www.intercell.com/main/forinvestors/downloads/quarterly-reports/
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 pipeline of investigational products includes a Travelers’ Diarrhea Vaccine Patch (Phase III), a Pseudomonas vaccine candidate (Phase II), a vaccine to prevent Pandemic Influenza combining our Vaccine Enhancement Patch 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, further products focused on infectious diseases are in pre-clinical development.
For more information, please visit www.intercell.com
CONTACT: Lucia Malfent, Intercell AG, +43-1-20620-1303,
LMalfent@intercell.com
Web site: http://www.intercell.com/
