ID Biomedical receives clearance for Fluviral clinical testing in the U.S.
2005年1月7日 - 11:15PM
PRニュース・ワイアー (英語)
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, ; To request a free copy of this
organization's annual report, please go to http://www.newswire.ca/
and click on reports@cnw.
Copyright