ID Biomedical (NASDAQ:IDBE)
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ID Biomedical to pursue U.S. accelerated approval process for its
influenza vaccine
VANCOUVER, March 15 /PRNewswire-FirstCall/ -- ID Biomedical Corporation (TSX:
IDB; NASDAQ: IDBE) announced today that it has been advised by the United
States Food and Drug Administration's Center for Biologics Evaluation and
Research (CBER) that the Company's injectable influenza vaccine is eligible for
accelerated approval and priority review mechanisms, allowing possible
licensure of the vaccine in time to manufacture product for the 2006/07 season.
Accelerated approval and priority review are specific regulatory programs
developed by FDA to expedite the availability of products addressing important
needs. ID Biomedical and CBER have outlined a clinical trial program that will
allow the Company to submit a Biologics License Application (BLA) later this
year.
"We are extremely pleased with the collaborative relationship we have
established with CBER, and their clear recognition of the importance of
expanding U.S. influenza vaccine availability," said Anthony Holler, M.D., ID
Biomedical's Chief Executive Officer. "Obviously nothing is guaranteed and we
have a lot of work to do, but we are optimistic we can be in the U.S. market by
next year, or a year ahead of expectations."
Approval to market the ID Biomedical flu vaccine in the U.S. will be based on
achieving agreed-upon safety and immunogenicity endpoints from clinical trials
that are already ongoing in Canada and the United States. Based on discussions
with CBER, the trial in the United States, originally announced on January 7,
2005, will be expanded to include up to approximately 1,000 subjects. ID
Biomedical believes it will be able to gather this data and, if positive, file
a Biologics License Application (BLA) by the end of 2005. If the data and
inspection of ID Biomedical's manufacturing facilities are acceptable, the
Company will be in the position to manufacture and ship influenza vaccine to
the United States market in 2006.
Additional post-approval confirmatory studies will be required. The Company has
agreed with CBER to conduct a confirmatory efficacy study in adults and also an
additional study of the immunogenicity of Fluviral in the elderly.
The Company also announced that the ongoing expansion and upgrading of its
Quebec-based flu vaccine manufacturing facilities is on schedule. ID Biomedical
expects that with U.S. regulatory approval of Fluviral and a successful
pre-approval inspection of its facilities, the company will be able to produce
approximately 20 million doses of influenza vaccine for the U.S. market in
2006, and approximately 40 million doses in 2007. ID Biomedical is also
committed to develop a preservative-free formulation of its product for the
pediatric population.
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. 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,
;
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