News
Intercell AG announces Q1 2011 results and updates on R&D progress
Vienna (Austria), May 10, 2011 – Today Intercell AG (VSE: ICLL) announced its Q1 results and presented an update on the Company’s R&D progress.
IXIARO®/JESPECT® – Significant sales increase leads to best Q1 sales revenues since product launch
Revenues from IXIARO®/JESPECT® product sales increased from EUR 0,4m in Q1 2010 to EUR 3.3m in Q1 2011. This excellent result in the usually weakest quarter of the year - due to travel seasonality - reflects the positive trend of increasing sales of IXIARO®/JESPECT® a already seen in 2010 in key travel markets and to U.S. military. Intercell’s vaccine is currently marketed to travelers in the U.S., EU, Australia, Canada and Switzerland and it is supplied to the U.S. military under an exclusive five-year contract.
Intercell expects a growth of sales to the U.S. military in 2011 due to higher vaccination rates and the finally expired stock of no longer manufactured JE-Vax®.
Intercell continues to expand the global availability of IXIARO® by increasing the number of regulatory approvals and subsequent launches in various global markets. Furthermore it is planning to launch the product with its partner Novartis in additional European countries as well as Hong Kong and Singapore as the first Asian territories during 2011.
The U.S. authorities recently confirmed to Intercell that the first postmarketing safety evaluation of IXIARO® concluded that no new safety concerns were identified and no labeling changes are requested at this time.
Phase III clinical trials for IXIARO® as JE vaccine candidate for children traveling to endemic areas are currently ongoing and the pediatric vaccine launch is expected for end 2012/beginning of 2013.
The pivotal Phase II/III trial in children living in Asia is progressing according to plan and first results are expected in 2011. This randomized and controlled study is the first pivotal Phase II/III study for the Intercell vaccine in an endemic region and is designed to lead to Asian licensure of the product. The vaccine is manufactured in India by Biological E. Ltd. and is based on Intercell’s technology. The first product launch for the new vaccine in Asia is expected in H1 2012. The WHO recommends that Japanese Encephalitis vaccination be integrated into national immunization programs in endemic areas.
Focus on leading position in vaccines against nosocomial infections
Next development steps for Pseudomonas vaccine candidate agreed with Novartis
In April, Intercell announced that it has agreed with Novartis to advance Intercell's investigational Pseudomonas aeruginosa vaccine into a confirmatory clinical efficacy trial in ventilated ICU (Intensive Care Unit) patients. The planned double-blind study is powered to show a clinically meaningful and statistically significant reduction in overall mortality between the vaccine and control group and envisages enrolling about 800 subjects. The study is subject to final regulatory concurrence and its start is planned for the first half of 2012. Intercell will execute the trial and the costs will be shared with Novartis.
The trial is expected to be conducted in various countries, predominantly in the EU, involving up to 50 study sites. Two study groups, both receiving standard of care in addition to the vaccine or placebo, will be compared. The subjects in the vaccine group, which will comprise about 400 ventilated ICU patients, will be vaccinated twice within a 7-day interval with the non-adjuvanted product formulation that was found to most impact observed survival. Primary endpoint of the trial will be mortality at day 28 after first vaccination in both study groups. Secondary objectives are to investigate Pseudomonas aeruginosa infections, infection-related mortality as well as immune response to the vaccine candidate and its safety and tolerability.
Intercell's Pseudomonas aeruginosa vaccine program is one of the development programs under the strategic alliance between Intercell and Novartis. Decisions on the program’s next steps will be based upon data from the planned efficacy trial, taking into consideration Novartis’ option rights and the Intercell right to choose between the option of profit-sharing or receiving milestones and royalties.
Staphylococcus aureus vaccine candidate (Phase II/III, Phase II)
On April 11, Intercell and Merck (known as MSD outside the United States and Canada) announced that following a pre-specified interim analysis from the Phase II/III clinical trial evaluating V710, the independent Data Monitoring Committee (DMC) recommended suspension of enrollment. Although the vaccine met the pre-specified efficacy criteria for non-futility, the independent Data Monitoring Committee (DMC) nonetheless recommended suspension of enrollment pending further analyses of the benefit/risk profile of the vaccine candidate. Merck and Intercell plan to provide a further update when analyses have been completed.
Data from a Phase II clinical study evaluating the immunogenicity and safety of V710 in patients with end-stage renal disease were presented by Merck at the National Kidney Foundation 2011, Spring Clinical Meetings (April 26-30) in Las Vegas and showed that the vaccine was immunogenic and generally well tolerated.
S. aureus is the most frequent cause of hospital-acquired infections. In addition to bloodstream infections with a mortality rate of up to 35%, infections of bone, heart and other inner organs lead to serious health complications, death and economic burden. Today, approximately 50% of S. aureus strains isolated in hospitals worldwide are resistant to multiple antibiotics, rendering staphylococcal disease management increasingly difficult and challenging.
Clostridium difficile vaccine candidate (Phase I) – main cause of nosocomial diarrhea
Intercell aims at developing a vaccine for the prevention of recurring C. difficile diarrhea for hospital prophylaxis and eventually a community-wide prophylaxis on an age- and risk-based vaccination strategy. The Phase I clinical study started at the end of 2010 and is progressing according to plan. First study results are expected for 2011.
C. difficile is the leading cause for nosocomial diarrhea in Europe and the U.S. It is estimated that in the U.S. alone, about 500,000 to three million people become infected every year while receiving hospital treatment. Currently, no vaccine against C. difficile exists and antibiotic treatment of the established disease has significant limitations.
Start of clinical trial in Pandemic Influenza with Intercell's Vaccine Enhancement Patch (VEP) – Intercell and GSK maintain commitment on strategic patch collaboration
On May 4, Intercell announced the start of a further trial in the field of Pandemic Influenza, investigating Intercell's adjuvant patch (Vaccine Enhancement Patch - VEP) containing LT (a heat-labile toxin from E. coli) in combination with GSK's H5N1 pandemic antigen. This trial follows prior work with a non-GSK Pandemic Influenza antigen carried out by Intercell under its contract with the U.S. Department of Health and Human Services (HHS) to develop a dose-sparing approach with potential for a single dose immunization.
The confirmatory trial will be performed under a Phase I protocol due to the introduction of a different H5N1 antigen. The study will involve 300 healthy adults and investigate various combinations of antigen and patch doses in one and two injection regimes to confirm the mode of action and the value of "external" adjuvantation. GSK's adjuvanted and licensed H5N1 vaccine will be used to provide a positive control for the patch and GSK's well established and validated H5N1 hemagglutination inhibition (HI) assay will be applied.
Intercell and GSK have maintained their commitment to continue to explore the value of the patch technology and will focus on evaluating the use of the patch technology for transcutaneous vaccination with existing or new antigens. Following the discontinuation of the Travelers' Diarrhea (TD) Vaccine Patch program as announced at the end of 2010, Intercell and GSK have mutually terminated the respective marketing and distribution collaboration. On this basis, all rights on the TD Vaccine Patch revert back to Intercell. Based on the clinical efficacy data obtained against LT-positive enterotoxigenic E. coli (ETEC) Intercell will continue to evaluate the potential of the vaccine candidate especially for endemic countries.
Additional candidate vaccines with high medical need progressing in development
Hepatitis C vaccine: Intercell and Romark joined forces in combining therapies against Hepatitis C. The companies are designing a treatment that combines Intercell’s investigational Hepatitis C vaccine with Romark’s antiviral drug, nitazoxanide. A combination Phase II trial is expected to start in H1 2011.
Pneumococcus vaccine: Intercell and its partner PATH are currently evaluating possible next development steps, following the successfully completed Phase I study in healthy adults.
Tuberculosis vaccine: Phase I clinical programs are proceeding according to schedule, and promising clinical data have been obtained in multiple Phase I studies. The start of a Phase II study is expected in 2011.
IC31® adjuvant: Novartis has initiated a Phase I clinical trial, combining an undisclosed vaccine candidate with Intercell's IC31® adjuvant. Under a Strategic Alliance Agreement signed in 2007, Novartis received a non-exclusive license for the use of IC31® in selected new vaccines.
Corporate
On May 5, Intercell announced that the company’s Supervisory Board has appointed Thomas Lingelbach as new Chief Executive Officer (CEO) for Intercell, effective May 10, 2011.
Gerd Zettlmeissl, current CEO, resigns from the Management Board as of today to pursue other personal and professional interests.
Key Financial Information
EUR in thousands | 3 months ended March 31, 2011 | 3 months ended March 31, 2010 | Year ended Dec. 31, 2010 |
|---|---|---|---|
Revenues | 5,692 | 4,756 | 34,215 |
Net loss | (11,257) | (14,702) | (255,182) |
Net operating cash flow | (23,453) | (15,468) | (65,120) |
Cash and marketable securities, end of period | 87,697 | 158,216 | 86,182 |
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