ID Biomedical (NASDAQ:IDBE)
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ID Biomedical's flu vaccine granted Fast Track status by FDA
- Company's plant upgrade and expansion on track - Capacity expected to
increase to approximately 75 million doses annually
VANCOUVER, July 12 /PRNewswire-FirstCall/ -- ID Biomedical Corporation (TSX:
IDB; NASDAQ: IDBE) announced today it has been advised by the United States
Food and Drug Administration's Center for Biologics Evaluation and Research
(CBER) that the Company's Influenza Virus Vaccine (Fluviral(TM)) has been
granted a Fast Track designation.
Under the Food and Drug Administration Modernization Act of 1997, the Fast
Track program was implemented to facilitate the development and expedite the
review of new drugs that are intended to treat serious or life-threatening
disease, and that demonstrate the potential to address unmet medical needs. The
Fast Track designation allows for frequent communications with the FDA and the
possibility of submitting portions of marketing application (BLA) before the
complete BLA is submitted.
Earlier this year, ID Biomedical announced that its flu vaccine was eligible
for accelerated approval and priority review. With this newly obtained Fast
Track designation, ID Biomedical has access to the major regulatory mechanisms
put in place by the FDA to facilitate rapid licensure. These programs are
applicable due to the ongoing shortages of influenza vaccine in the United
States.
"We are very pleased to receive Fast Track designation for our injectable flu
vaccine," said Jane Halpern, ID Biomedical's Vice President of Regulatory
Affairs. "This designation along with our access to accelerated approval and
priority review mechanisms clearly signal the importance of expanding flu
vaccine availability in the United States."
The Company also announced today that the ongoing expansion and upgrading of
its Quebec-based flu vaccine manufacturing facilities is on schedule. The
construction work to expand the primary influenza vaccine manufacturing site in
Quebec City is completed and the validation process has been initiated. The
upgrade of the Laval facility has begun to allow additional upstream
capabilities. The expansion at the Quebec City facility, the upgrade at the
Laval facility and the harmonization of the two facilities will allow ID
Biomedical to further increase its production capacity from the 50 million
doses production capacity originally announced (utilizing only the Quebec City
plant), to approximately 75 million doses per year in 2007, after all expansion
and upgrade work is completed at both sites.
"We now have access to all three regulatory mechanisms available to expedite
regulatory approval of our flu vaccine in the United States and we are working
diligently toward this important goal," said Dr. Anthony Holler, ID
Biomedical's Chief Executive Officer. "Additionally, the expansion of our
production capacity is right on track. Once completed, ID Biomedical will be
positioned as one of the largest flu vaccine manufacturers in the world. This
is a tremendous opportunity given the continuing worldwide shortage of flu
vaccines."
ID Biomedical expects that with the U.S. regulatory approval of its injectable
flu vaccine and a successful pre-approval inspection of its facilities, the
company will be able to produce approximately 20-25 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
will house 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, Dean Linden, (604) 431-9314,
; Media, Michele Roy, (450) 978-6313,
;
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