ID Biomedical's flu vaccine granted Fast Track status by FDA
12 7월 2005 - 11:00PM
PR Newswire (US)
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, ; To request a free
copy of this organization's annual report, please go to
http://www.newswire.ca/ and click on reports@cnw.
Copyright