ID Biomedical Provides Update on Vaccine Development Programs
October 24 2005 - 10:40AM
PR Newswire (US)
- Clinical testing of FluINsure in children has begun - Clinical
testing of StreptAvax to be postponed VANCOUVER, Oct. 24
/PRNewswire-FirstCall/ -- ID Biomedical Corporation (TSX: IDB;
NASDAQ: IDBE) today provided an update on two of its lead vaccines
in clinical development: FluINsure(TM), a non-living intranasally
delivered influenza vaccine, and StreptAvax(TM), a subunit
protein-based vaccine against group A streptococcal diseases. ID
Biomedical announced that it has obtained clearance from Health
Canada to begin the first pediatric study of the FluINsure vaccine.
This Phase II study will be conducted at three centers in Canada in
160 healthy children, aged 3 to 12 years old. The study will be
blinded, randomized, and placebo- controlled and will evaluate
safety and immunogenicity of one-dose and two- dose regimens of the
vaccine. Enrollment for the study has begun. The Company also
announced that it recently held a pre-Investigational New Drug
("IND") meeting with the U.S. Food and Drug Administration ("FDA")
regarding the pediatric development program for its StreptAvax
vaccine. At the pre-IND meeting, the FDA asked the Company to
provide a significant amount of additional information and
follow-up from the recently completed adult study prior to further
considering initiation of studies in children. At this time, ID
Biomedical is not able to precisely predict how long it may take to
generate this data and to what extent additional testing and follow
up in adults may be required before obtaining approval to conduct
studies in children. Based on a preliminary assessment of the
nature and the amount of information requested by the FDA, the
Company does not currently expect to begin testing the vaccine in
children in the U.S. prior to 2007. The Company expects additional
dialogue with the FDA regarding the requirements for continuing
development of the vaccine candidate. About ID Biomedical ID
Biomedical is an integrated biotechnology company dedicated to the
development of innovative vaccine products. It operates in
research, development, manufacturing, sales and marketing from its
facilities in Canada and in the United States. ID Biomedical is
dedicated to becoming a premier vaccine company with significant
marketed products worldwide and an extensive pipeline in both
clinical and preclinical development. ID Biomedical has a leading
position in the Canadian influenza market. It received a ten-year
mandate from the Government of Canada in 2001 to assure a state of
readiness in the case of an influenza pandemic and provide
influenza vaccine for all Canadians in such an event. It also
currently supplies approximately 75% of the Canadian government's
influenza vaccine purchases. On September 7, 2005, ID Biomedical
announced an agreement for GlaxoSmithKline to acquire ID
Biomedical. The acquisition, which has been approved unanimously by
both GlaxoSmithKline and ID Biomedical's Boards of Directors, is
subject to the approval of ID Biomedical's shareholders, applicable
regulatory clearances and certain other conditions. The transaction
is expected to close by the end of 2005 or early 2006. For further
information on ID Biomedical, please visit the Company's website at
http://www.idbiomedical.com/. The information in this news release
contains so-called "forward-looking" statements. These include
statements regarding ID Biomedical's expectations and plans
relating to the integration of the vaccine business acquired from
Shire, statements about ID Biomedical's expectations, beliefs,
intentions or strategies for the future, which may be indicated by
words or phrases such as "anticipate", "expect", "intend", "plan",
"will", "we believe", "ID Biomedical believes", "management
believes", and similar language. All forward-looking statements are
based on ID Biomedical's current expectations and are subject to
risks and uncertainties and to assumptions made. Important factors
that could cause actual results to differ materially from those
expressed or implied by such forward-looking statements include:
(i) the company's ability to successfully complete preclinical and
clinical development of its products; (ii) the company's ability to
manufacture its products; (iii) the seasonality of the flu-vaccine
business and related fluctuations in the company's revenues from
quarter to quarter; (iv) decisions, and the timing of decisions,
made by the health regulatory agencies regarding approval of its
products for human testing; (v) the company's ability to enter into
distribution agreements for its products, and to complete and
maintain corporate alliances relating to the development and
commercialization of its technology and products; (vi) market
acceptance of its technologies and products; and (vii) the
competitive environment and impact of technological change and
other risks detailed in the company's filings with the Securities
and Exchange Commission. ID Biomedical bases its forward-looking
statements on information currently available to it, and assumes no
obligation to update them. For further information, please contact:
Investor Relations/Media Dean Linden Michele Roy (604) 431-9314
(450) 978-6313 DATASOURCE: ID Biomedical Corporation CONTACT:
Investor Relations/Media: Dean Linden, (604) 431-9314, ; Michele
Roy,(450) 978-6313, ; To request a free copy of this organization's
annual report, please go to http://newswire.ca/ and click on Tools
for Investors.
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