ID Biomedical to pursue U.S. accelerated approval process for its influenza vaccine
March 15 2005 - 9:30AM
PR Newswire (US)
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, ; 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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