ID Biomedical Completes Enrollment of 1,000 Subjects for Pivotal Fluviral Clinical Trial in the U.S.
31 March 2005 - 1:42AM
PR Newswire (US)
ID Biomedical Completes Enrollment of 1,000 Subjects for Pivotal
Fluviral Clinical Trial in the U.S. VANCOUVER, March 30
/PRNewswire-FirstCall/ -- ID Biomedical Corporation (TSX: IDB;
NASDAQ: IDBE) announced today that it has completed the enrollment
of 1,000 subjects for its Fluviral clinical trial intended to
support accelerated approval in the United States. As recently
announced, the Company expanded this trial from 300 subjects to
1,000 healthy adults from age 18 to 64. This randomized,
double-blind, comparator-controlled study is designed to evaluate
the safety and immunogenicity of Fluviral in healthy adults. "We
are extremely pleased with the quick enrollment of the 1,000
subjects in this clinical trial. The completion of the enrollment
arrives six weeks earlier than we had originally expected. This
achievement represents another very positive step towards a BLA
filing later in the year with a view, pending necessary regulatory
approvals, to manufacture and ship influenza vaccine to the United
States for the 2006-2007 season," said Anthony Holler, M.D., ID
Biomedical's Chief Executive Officer. ID Biomedical is also
conducting a similar clinical trial of Fluviral in Canada. The
Canadian clinical trial enrolled 658 people and is also designed to
evaluate the safety and immunogenicity of Fluviral. The Canadian
trial is being conducted in adults in two age groups, 50 to 64
years old and over 64 years of age; these data will also be filed
in support of U.S. licensure. On March 15, ID Biomedical announced
that it has been advised by the United States Food and Drug
Administration's Center for Biologics Evaluation and Research
(CBER) that Fluviral is eligible for accelerated approval and
priority review mechanisms. ID Biomedical and CBER have outlined a
clinical trial program that will allow the Company to submit a
Biologics License Application (BLA) by the end of 2005. The
approval to market the ID Biomedical injectable influenza vaccine
in the U.S. will be based on achieving agreed-upon safety and
immunogenicity endpoints from these ongoing clinical trials in
Canada and the United States. ID Biomedical produces Fluviral from
its two flu vaccine production facilities located in Laval and
Quebec City, Quebec. The company's Quebec City facility is being
expanded to increase total manufacturing capacity to approximately
50 million doses by 2007, and will house what is believed to be the
newest egg-based vaccine production facility in the world. The
production capacity of ID Biomedical for the U.S. market in
2006-2007 is expected to be approximately 20-25 million doses. Upon
FDA approval, Fluviral will be distributed in the U.S. by ID
Biomedical's distribution partners: Henry Schein, Inc.,
AmerisourceBergen Corporation's Specialty Group and McKesson
Corporation. These distribution partners have agreed to purchase
and distribute 38 million doses of the Company's flu vaccine
annually beginning in 2007. If ID Biomedical obtains FDA approval
by April 1, 2006 under the accelerated approval mechanism, then the
agreement will be applicable to the 2006 season as well. 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. 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 integrate the Shire
vaccine business; (ii) the company's ability to successfully
complete preclinical and clinical development of its products;
(iii) the company's ability to manufacture its products; (iv) the
seasonality of the flu-vaccine business and related fluctuations in
the company's revenues from quarter to quarter; (v) decisions, and
the timing of decisions, made by the health regulatory agencies
regarding approval of its products for human testing; (vi) 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; (vii) market acceptance of its technologies and products;
and (viii) 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://www.newswire.ca/ and click on reports@cnw.
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