ID Biomedical (NASDAQ:IDBE)
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ID Biomedical receives clearance for Fluviral clinical testing in
the U.S.
VANCOUVER, Jan. 7 /PRNewswire-FirstCall/ -- ID Biomedical Corporation (TSX:
IDB; NASDAQ: IDBE) announced today that it has received clearance from the U.S.
Food and Drug Administration (FDA) to begin immediate clinical testing of its
influenza vaccine, Fluviral(TM), in the United States under an Investigational
New Drug application (IND). The Company intends to ship product to the U.S. and
initiate enrollment of subjects before the end of January 2005. The Fluviral
vaccine to be tested was produced using a terminal sterile filtration step.
This minor modification to the production process is an FDA requirement for flu
vaccines entering the U.S. market. ID Biomedical also announced that it has
completed enrollment of a similar clinical trial of Fluviral in Canada.
The U.S. clinical trial will involve approximately 300 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. The Canadian clinical trial enrolled 658 people and is also designed to
compare the safety and immunogenicity of Fluviral utilizing the new production
process versus a comparator flu vaccine. The Canadian trial is being conducted
in adults in two age groups, 50 to 64 years old and over 64 years of age,
thereby addressing a key vaccine target population in both the U.S. and Canada.
Between the Canadian and U.S. studies, ID Biomedical will test Fluviral in 958
people, with 528 subjects receiving Fluviral and 430 receiving a comparator
influenza vaccine. Over the last several years, over 40 million doses of
Fluviral have been distributed throughout Canada. ID Biomedical is the market
leader for influenza vaccines in Canada, and is one of only two flu vaccine
manufacturers located in North America.
"We are very excited to initiate clinical testing of Fluviral in the U.S. We
believe this trial data, along with that being obtained from our ongoing
Canadian study, will be necessary to support licensure of Fluviral for the U.S.
market. We are currently in active discussions with the FDA regarding our
clinical and regulatory strategy for Fluviral's entry into the U.S. Once we
have a full picture, we can determine whether accelerated approval is feasible
for this year," commented Louis F. Fries, M.D., Vice President, Clinical
Affairs.
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 in 2005 is expected to be approximately 22 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.
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
(604) 431-9314
Michele Roy
(450) 978-6313
DATASOURCE: ID Biomedical Corporation
CONTACT: Investor Relations / Media, Dean Linden, (604) 431-9314,
; Michele Roy, (450) 978-6313,
;
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