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Novartis completes shipment of US supply of Fluvirin? seasonal influenza vaccine

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  • Novartis completes shipment of US supply of Fluvirin? seasonal influenza vaccine

    2009-10-06 07:18:02 -

    * 27 million doses shipped to US market by Novartis - providing
    more seasonal flu vaccine earlier than in any previous year

    * Shipments completed ahead of normal seasonal vaccine delivery
    schedules to allow for earlier vaccination

    * First shipments of A(H1N1) vaccine delivered to US government
    less than four months after the pandemic declaration by the WHO

    Basel, October 6, 2009 - Novartis announced today that the company
    has completed its entire shipment of seasonal influenza vaccine to
    the United States for the 2009/2010 season. As previously
    anticipated, the company delivered 27 million doses of Fluvirin?
    influenza virus vaccine, which has been approved by the U.S. Food and
    Drug Administration (FDA).
    Novartis completed this season's shipment
    earlier than in previous years, in anticipation of demand for earlier
    vaccination with seasonal influenza vaccine created by the current
    global A(H1N1) influenza pandemic.

    "Novartis is pleased to have delivered more seasonal influenza
    vaccine to the US market by the end of September than we have in any
    previous year allowing more people to get their vaccine early in the
    season," said Andrin Oswald, CEO of Novartis Vaccines and
    Diagnostics. "We are relieved to have been able to complete our
    deliveries ahead of schedule despite the challenging task to produce
    large quantities of A(H1N1) pandemic vaccines at the same time.
    We
    hope that the early delivery of our Fluvirin vaccine will help
    physicians and public health officials better prepare for the
    upcoming flu season and balance the needs for pandemic and seasonal
    vaccination."

    On September 27, Novartis also began shipments of the first doses of
    its influenza A(H1N1) 2009 monovalent vaccine[1] to the United
    States.
    The early shipment is the first of an accelerated effort to
    provide as much A(H1N1) vaccine as soon as possible, despite the low
    yield seen with the initial production seed strain provided by the
    World Health Organization. Production has switched to a new higher
    yielding seed strain which will allow deliveries of higher volumes
    later in the year.


    Novartis Influenza A(H1N1) 2009 monovalent vaccine was approved by
    the FDA on September 15, 2009.
    The A(H1N1) vaccine is an inactivated
    subunit vaccine approved for active immunization of persons 4 years
    of age and older, including patients with underlying chronic medical
    conditions. The US Department of Health and Human Services (HHS)
    awarded Novartis two contracts totaling USD 979 million for purchase
    of H1N1 bulk vaccine and the Novartis proprietary MF59 adjuvant.


    The Novartis seasonal influenza vaccine, Fluvirin is indicated for
    patients 4 years and older. Fluvirin vaccine contains antigens to the
    three influenza virus strains for this year's vaccine recommended by
    the World Health Organization (WHO) in January 2009:

    * A/Brisbane/59/2007, IVR-148 (H1N1)
    * A/Uruguay/716/2007, NYMC X-175C (H3N2) (an
    A/Brisbane/10/2007-like virus)
    * B/Brisbane/60/2008[2]


    About seasonal influenza
    Seasonal influenza is a highly communicable, acute viral infection
    that predominantly attacks the respiratory tract and sometimes the
    lungs. It can cause mild to severe illness and can lead to death[3].

    The number of people in the U.S. who die every year from the flu is
    similar to the more than 40,000 people in the U.S. estimated to die
    from breast cancer every year[4] and about half of the estimated
    70,000 people who die annually of diabetes and its complications[5].
    During the 2007-2008 influenza season, 83 children were reported to
    have died of influenza-related causes[6]. Of the 63 whose vaccination
    status was known, 58 (92 percent) were not vaccinated according to
    recommendations[7]. Final numbers for the 2008-2009 flu season are
    not yet available.

    Influenza vaccination is one of the most effective public health
    interventions ever implemented, sparing millions of people from
    complications of the infectious disease. Use of currently available
    seasonal flu vaccines has been calculated to save more than 8 million
    lives annually; translating to one person saved every five
    seconds[8].

    ACIP recommends seasonal influenza vaccinations as the principal
    method of preventing seasonal influenza. The vaccine is recommended
    for those at greatest risk for serious complications, including:

    * Children between 6 months and 18 years of age
    * Pregnant women
    * People 50 years of age and older
    * People of any age with certain chronic health conditions, such as
    asthma, diabetes or heart disease
    * People in nursing homes and other long-term care facilities,
    * Household contacts of person at high risk for complications from
    influenza,
    * Household contacts and out-of-home caregivers of children less
    than 6 months of age
    * Healthcare workers[9]

    Important safety information
    As is the case with most drugs and vaccines, there is a chance that a
    serious allergic reaction, serious illness or even death could occur
    as a result of vaccination with Fluvirin vaccine. The most common
    side effect of vaccination with Fluvirin influenza virus vaccine is
    soreness at the injection site. Less common side effects include
    fever, malaise, myalgia and allergic reactions. Fluvirin vaccine
    should not be administered to anyone with a history of
    hypersensitivity to any component of the vaccine, including eggs, egg
    products or thimerosal. Generally, persons should not be vaccinated
    during an acute febrile illness. Vaccination should be delayed in
    persons with an active, unstable neurological disorder, but should be
    considered when the disorder has been stabilized. The occurrence of
    any neurological symptoms or signs following administration of any
    vaccine is a contraindication to further use. Fluvirin vaccine is not
    indicated for use in children under four years of age. Persons should
    consult with their healthcare providers if they are pregnant and/or
    are taking other medications.
    Fluvirin vaccine may not protect 100%
    of individuals who are susceptible to influenza. Before administering
    Fluvirin vaccine, please see full prescribing information.

    Important Safety Information for US Market
    Adverse reaction information is based on studies conducted with
    seasonal trivalent Influenza Virus Vaccine manufactured by Novartis
    (Fluvirin). The most frequently reported adverse reactions are mild
    hypersensitivity reactions (such as rash), local reactions at the
    injection site, and influenza-like symptoms. For patients who have
    experienced Guillain-Barr? syndrome within 6 weeks of receipt of
    prior influenza vaccine, the decision to administer Influenza A
    (H1N1) 2009 Monovalent Vaccine should be based on careful
    consideration of the potential benefits and risks. Immunocompromised
    persons may have a reduced immune response to Influenza A (H1N1) 2009
    monovalent vaccine.

    Disclaimer
    The foregoing release contains forward-looking statements that can be
    identified by terminology such as "hope," "will," or similar
    expressions, or by express or implied discussions potential future
    deliveries of influenza vaccines, or regarding potential future
    revenues from influenza vaccines. You should not place undue reliance
    on these statements. Such forward-looking statements reflect the
    current views of management regarding future events, and involve
    known and unknown risks, uncertainties and other factors that may
    cause actual results to be materially different from any future
    results, performance or achievements expressed or implied by such
    statements. There can be no guarantee that Novartis will successfully
    meet its delivery obligations for its influenza vaccines. Neither
    can there be any guarantee that Novartis' influenza vaccines will
    achieve any particular levels of revenue in the future. In
    particular, management's expectations regarding Novartis' influenza
    vaccines could be affected by, among other things, unexpected
    regulatory actions or delays or government regulation generally;
    unexpected manufacturing difficulties or delays, including unexpected
    difficulties with our flu cell culture manufacturing facility and
    processes; unexpected clinical trial results, including unexpected
    new clinical data and unexpected additional analysis of existing
    clinical data;
    the company's ability to obtain or maintain patent or
    other proprietary intellectual property protection; competition in
    general; government, industry and general public pricing pressures;
    the impact that the foregoing factors could have on the values
    attributed to the Novartis Group's assets and liabilities as recorded
    in the Group's consolidated balance sheet, and other risks and
    factors referred to in Novartis AG's current Form 20-F on file with
    the US Securities and Exchange Commission. Should one or more of
    these risks or uncertainties materialize, or should underlying
    assumptions prove incorrect, actual results may vary materially from
    those anticipated, believed, estimated or expected. Novartis is
    providing the information in this press release as of this date and
    does not undertake any obligation to update any forward-looking
    statements contained in this press release as a result of new
    information, future events or otherwise.


    About Novartis
    Novartis Vaccines and Diagnostics is a division of Novartis focused
    on the development of preventive treatments. The division has two
    businesses: Novartis Vaccines and Novartis Diagnostics. Novartis
    Vaccines is the world's fifth-largest vaccines manufacturer and
    second-largest supplier of flu vaccines in the US. The division's
    products also include meningococcal, pediatric and travel vaccines.
    Novartis Diagnostics prevents the spread of infections through the
    development and marketing of innovative technologies that enable
    early detection of pathogens to protect the world's blood supply and
    prevent the spread of infectious diseases.

    Novartis provides healthcare solutions that address the evolving
    needs of patients and societies. Focused solely on healthcare,
    Novartis offers a diversified portfolio to best meet these needs:
    innovative medicines, cost-saving generic pharmaceuticals, preventive
    vaccines, diagnostic tools and consumer health products. Novartis is
    the only company with leading positions in each of these areas. In
    2008, the Group's continuing operations achieved net sales of USD
    41.5 billion and net income of USD 8.2 billion. Approximately USD 7.2
    billion was invested in R&D activities throughout the Group.
    Headquartered in Basel, Switzerland, Novartis Group companies employ
    approximately 99,000 full-time-equivalent associates and operate in
    more than 140 countries around the world. For more information,
    please visit www.novartis.com.
    </pre>


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