SINOVAC BIOTECH LTD. SIGNS AVIAN FLU VACCINE
CO-DEVELOPMENT AGREEMENT WITH CHINA CENTRE OF DISEASE CONTROL AND PREVENTION
(CHINA CDC)
BEIJING, December 17, 2004 – Sinovac Biotech Ltd. ("Sinovac") (“the
Company”) (AMEX: SVA) announces that it has signed an Avian Flu Vaccine
Co-development Agreement with China Centre of Disease Control and Prevention
(China CDC).
China CDC is responsible for surveillance of influenza prevalence, molecular
epidemiology study of the virus strain, guidance and establishment of avian
flu vaccine development strategy, participation in avian flu vaccine
research and development, and the design of the technical roadmap. Sinovac
is responsible for avian flu vaccine research and development based on the
established technical platform and vaccine application and production.
Furthermore, China CDC is responsible for conducting several tests,
including genome analysis on the virus strains used in the vaccine R&D,
antigen analysis, and immunization protection analysis among others. Lastly,
China CDC is also responsible for providing guidance on the scope of use of
the vaccine, storage of the vaccine, and the evaluation of the protection of
the vaccine.
The two parties intend to apply for government funding for this avian flu
vaccine co-development project.
Under the terms of the agreement, the new drug certificate, production
license, and patents will all be applied for by Sinovac and as a result the
commercial rights will be owned by Sinovac.
The World Health Organization influenza network began providing the
prototype bird flu virus early in 2004 to vaccine makers around the world.
Sinovac received the virus in April 2004.
About China CDC
Chinese Center for Disease Control and Prevention (China CDC) is the
nonprofit government funded institution working in the fields of disease
control and prevention, public health management and provision of service.
China CDC is committed to retain the nation’s stability, to protect the
country’s security, and to enhance people’s health through disease
prevention. The tenet of China CDC is to rely on science and study, to be
based on intelligence, and to focus on disease control.
Avian Flu
World health authorities have recently warned that if the current avian flu
virus mutates into a form that spreads easily among people it could lead to
the next global flu pandemic, which could kill tens of millions of people
worldwide. Pandemics occur when a completely new flu strain emerges for
which humans have no immunity.
Influenza experts and world health authorities are concerned that the recent
appearance and widespread distribution of an avian influenza virus, H5N1,
has the potential to ignite the next flu pandemic. Given the current threat,
world health authorities are currently urging all countries to develop or
update their influenza pandemic preparedness plans for responding to the
widespread socioeconomic disruptions that would result from having large
numbers of people sick or dying.
Central to preparedness is an estimate of how deadly the next pandemic is
likely to be. Experts' answers to this question have ranged from 2 million
to over 50 million. All these answers are scientifically grounded. There are
several reasons for the wide range of estimates.
Some estimates are based on extrapolations from past pandemics but
significant details of these events are disputed, including the true numbers
of deaths that resulted. The most precise predictions are based on the
pandemic in 1968 but even in this case estimates vary from one million to
four million deaths. Similarly, the reported number of deaths from the
Spanish flu pandemic of 1918 by different investigators ranges from 20
million to well over 50 million. Extrapolations are problematic because the
world in 2004 is a different place from 1918. The impact of greatly improved
nutrition and health care needs to be weighed against the contribution the
increase in international travel would have in terms of global spread. The
specific characteristics of a future pandemic virus cannot be predicted. It
may affect between 20-50% of the total population. It is also unknown how
pathogenic a novel virus would be, and which age groups will be affected.
The level of preparedness will also influence the final death toll. Even
moderate pandemics can inflict a considerable burden on the unprepared and
disadvantaged. Planning to maintain health care systems will be especially
crucial. Good health care will play a central role in reducing the impact,
yet the pandemic itself may disrupt the supply of essential medicines and
health care workers may fall ill. Because of these factors, confidently
narrowing the range of estimates cannot be done until the pandemic emerges.
World health authorities state that even in the best case scenarios of the
next pandemic, 2 to 7 million people would die and tens of millions would
require medical attention. If the next pandemic virus is a very virulent
strain, deaths could be dramatically higher. The global spread of a pandemic
cannot be stopped but preparedness will reduce its impact.
In summary, world health authorities believe that the appearance of H5N1,
which is now widely entrenched in Asia, signals that the world has moved
closer to the next pandemic. While it is impossible to accurately forecast
the magnitude of the next pandemic, it is known that much of the world is
currently unprepared for a pandemic of any size.
About Sinovac Biotech Ltd.
Sinovac Biotech Ltd. specializes in the research, development,
commercialization, and sales of human vaccines for infectious illnesses such
as hepatitis A and hepatitis B, influenza, “SARS”, and avian flu. Sinovac is
one of the leading emerging biotechnology companies in China.
Sinovac has three vaccines that have completed all three phases of clinical
trials – Hepatitis A, Hepatitis A&B combined, and influenza (flu). The
Hepatitis A vaccine, Healive™, is currently experiencing strong sales growth
in China and applications have been filed for its sale in nine other
countries to date. Sinovac’s Hepatitis A&B combined vaccine, Bilive™, is
expected to receive approval to commence sales in China soon and to achieve
similar sales growth to Healive™. The flu vaccine completed clinical trials
in April 2004 and a New Drug Application has been filed with the SFDA
(Chinese FDA). Approval of Sinovac’s flu vaccine is expected in 2005 upon
completion of the flu vaccine production line.
Sinovac is currently the only company in the world to be conducting clinical
trials for a vaccine to prevent SARS. The Company is co-developing a vaccine
targeting avian flu with China CDC.
For further information please refer to the Company’s filings with the SEC
on EDGAR or refer to Sinovac’s website at
www.sinovac.com.
If you would like to receive regular updates on Sinovac please send your
email request to info@sinovac.com
Contact: Investor Relations at (888) 888-8312 or 1 604 684-5990 from outside
of North America or info@sinovac.com
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WITHIN THE MEANING OF SECTION 27A OF THE UNITED STATES SECURITIES ACT OF
1933, AS AMENDED, AND SECTION 21E OF THE UNITED STATES SECURITIES AND
EXCHANGE ACT OF 1934, AS AMENDED, WITH RESPECT TO ACHIEVING CORPORATE
OBJECTIVES, DEVELOPING ADDITIONAL PROJECT INTERESTS, SINOVAC'S ANALYSIS OF
OPPORTUNITIES IN THE ACQUISITION AND DEVELOPMENT OF VARIOUS PROJECT
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ACTUAL RESULTS TO DIFFER MATERIALLY FROM THOSE IN THE FORWARD-LOOKING
STATEMENTS CONTAINED HEREIN
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