DJ EANS-Adhoc: Intercell AG Announces Q3 2009 Results and Updates on R&D Progress and Management:
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09.11.2009
» Progress on Japanese Encephalitis vaccine (IXIARO®/JESPECT®) business and
global reach - approval in Canada obtained - Phase III study start in
India for JE-vaccine for endemic countries imminent
» Start of the Phase III study for Travelers' Diarrhea Vaccine Patch in
October
» Phase II data for single-dose Pandemic Influenza vaccine with Vaccine
Enhancement Patch expected before end 2009
» First interim data from Phase II for Pseudomonas vaccine expected before
end of 2009
» Net loss for the first nine months increased to EUR 25.9m - Revenues
increased by 16.6% in the same period - Lower than anticipated sales
increase for IXIARO® with Q3 sales revenues of EUR 2.7m
» Strong Q4 revenues anticipated from expected partnering of future
commercialization of Travelers' Diarrhea Vaccine and of certain aspects
of Patch Technology
» Lower than anticipated IXIARO® sales revenues and significant investments
in strongly progressing late-stage development programs likely to result
in full year net loss
» Management Board appointed for the next three years; Alexander von Gabain
to transition from Management Board (Chief Scientific Officer) into a new
strategic role within the Company
Vienna (Austria), November 9, 2009 - Today, Intercell AG (VSE: ICLL) announced
its financial results for the third quarter of 2009 and presented an update on
the Company's key R&D programs as well as changes to the Management Board.
Japanese Encephalitis vaccine: Progress on IXIARO®/JESPECT® business and global
reach
The market preparation and launch activities in the 30 countries where
IXIARO®/JESPECT® is approved have been slower than anticipated, with more than
50% of the countries still awaiting product launch. Significant efforts are
needed to create national recommendations for JE-vaccination, to build awareness
and hence optimize product uptake in the markets. Some countries have
successfully reached vaccination rates that are already now in reach of the
anticipated business opportunity and hence we are optimistic that others can
achieve similarly over time. First deliveries of IXIARO® to the U.S. military
were concluded in September under the exclusive Supply Agreement signed earlier
this year. As sole supplier for the U.S. military, Intercell is working closely
with the Army's health representatives on recommendations towards an increased
use of the novel, cell-culture vaccine to prevent Japanese Encephalitis (JE).
Recently Intercell reported that Health Canada granted product approval for
IXIARO®. This decision of the Canadian authorities represents another important
milestone for the product's global reach. Intercell's vaccine has already been
successfully approved and launched in the USA, Europe, and Australia. The
vaccine will be available for the Canadian market by the end of the year and
will be distributed and marketed to travelers by Novartis Pharmaceuticals Canada
Inc. and to the military personnel by Intercell.
Additionally Intercell has initiated regulatory licensure processes in other,
small territories where there is an attractive market segment for a product
already approved in highly regulated environments. Intercell AG and its partner
Biological E. Ltd. are expecting an imminent start of a pivotal Phase III study
for the investigational vaccine to protect children and adults from JE. The
investigational vaccine is manufactured in India by Biological E. and is based
on Intercell's technology, which was successfully used to gain product licensure
of the adult vaccine in Europe, the United States, and Canada (IXIARO®) as well
as in Australia (JESPECT®). The randomized and controlled study will be the key
pivotal Phase III trial in an endemic region towards licensure of the JE
vaccine. The planned Phase III trial will investigate safety and immunogenicity
compared to JenceVacTM, the locally licensed, Korean-made, inactivated, mouse
brain-derived JE vaccine. The approval of the vaccine in India is expected by
the end of 2010 with WHO pre-qualification planned to follow in 2011.
Strong performance on late-stage patch-based vaccine pipeline
In October, Intercell's investigational Travelers' Diarrhea (TD) Vaccine Patch
entered clinical Phase III development. This pivotal efficacy field study
started with the first subjects vaccinated in the United Kingdom. The randomized
and placebo-controlled study with 1,800 travelers from Europe to Mexico and
Guatemala will evaluate the efficacy of the TD Vaccine Patch to actively
immunize against moderate to severe enterotoxigenic E. coli (ETEC) disease in a
field setting.
The investigational TD vaccine system consists of a self-adhesive patch
containing the vaccine antigen, the heat-labile toxin (LT) from E. coli, and a
single-use device used to prepare the skin at the site of patch administration,
the Skin Preparation System (SPS). Intercell combines the classical toxin
approach to vaccination with its innovative patch-based, needle-free delivery
system. The SPS partially disrupts the stratum corneum of the skin. The dry
patch contains the antigen in a stabilizing excipient formulation and delivers
the antigen through the skin.
Phase II data for an investigational Vaccine Enhancement Patch to potentially
enable single application for Pandemic Influenza prevention is expected before
the end of 2009.
The clinical trial is investigating Intercell's Vaccine Enhancement (VE) Patch
in combination with an injectable H5N1 Pandemic Influenza vaccine (manufactured
by Solvay Biologicals, B.V., The Netherlands) and enrolled 500 subjects in the
USA with serological analysis under way. The study, as part of Intercell`s
overall PanFlu program, is fully funded by the U.S. Department of Health and
Human Services (HHS).
In 2008, Intercell announced the results of a Phase I clinical trial in a
similar setting with the VE Patch combined with an injectable H5N1 Influenza
vaccine. The data revealed that a single 45-microgram dose of the H5N1 Influenza
vaccine, when administered with the Intercell VE Patch containing 50-microgram
LT adjuvant, was sufficient to provide an immune response seen to be protective
in 73% of the vaccinees. This was the first time that a single dose of H5N1
Pandemic Influenza vaccine met the level of protection suggested in the U.S.
Food and Drug Administration guidance. The U.S. Food and Drug Administration
considers a pandemic vaccine to be protective if it achieves immune response
levels in at least 70% of the vaccine recipients.
Excellent progress for all other clinical programs
Staphylococcus aureus vaccine (V710) clinical program: First critical interim
analysis (surpassing futility) from the ongoing Phase II/III trial in
cardiothoracic surgery patients is expected in 2010. The Phase II/III trial is
designed to evaluate investigational vaccine efficacy/safety in patients
undergoing cardiothoracic surgery. To date, the trial has experienced slower
than anticipated enrollment and accrual of individuals with S. aureus
infections. The double-blind, randomized, placebo-controlled trial utilizes an
adaptive (group-sequential) design incorporating several interim analyses to
evaluate accrued data and allow for objective assessment of study progress. The
study involves more than 90 centers in 18 countries, including the USA, Europe,
South America, and Japan.
Collaborator Merck & Co., Inc. is responsible for clinical development,
manufacturing, and marketing.
Pseudomonas aeruginosa vaccine:
First interim data on the Phase II study are expected by the end of 2009.
Intercell's investigational prophylactic Pseudomonas aeruginosa vaccine aims to
protect Intensive Care Unit (ICU) patients against Ventilator-Associated
Pneumonia (VAP) and Bacteremia. For the current Phase II clinical trial, about
400 patients are enrolled in more than 50 ICUs in 11 countries in Europe and
Latin America.
Streptococcus pneumoniae vaccine:
Initial results of the clinical Phase I trial with the Company's protein-based
vaccine are expected at the beginning of 2010. The program is financially
supported by PATH.
Therapeutic Hepatitis C vaccine:
the strategic partnering process is progressing well and it is expected that a
partnership will be closed in the first half of 2010. The strategic aim is to
combine Intercell´s vaccine approach, which in a previous Phase II trial showed
a significant virus decline in chronic Hepatitis C patients, with a small
molecule treatment scheme of the potential partner.
Tuberculosis vaccine:
Phase I/II clinical programs are proceeding according to plan. These programs
are based on a partnership between Intercell, Statens Serum Institut, Sanofi
Pasteur, and the AERAS Global Tuberculosis Foundation. Further clinical data is
expected for 2010.
Management Board
Intercell's Supervisory Board confirmed the existing Management Board members
Gerd Zettlmeissl as Chief Executive Officer and Thomas Lingelbach as Chief
Operating Officer for the next three years.
Reinhard Kandera, Chief Financial Officer since March 2009, has been appointed
for a term of three years as a new member of Intercell's Management Board.
Kandera, who joined Intercell in 2001, has served the Company in different areas
of responsibility - most recently as Global Head of Investor Relations and Chief
(MORE TO FOLLOW) Dow Jones Newswires
November 09, 2009 01:28 ET (06:28 GMT)
