CAMBRIDGE, MA--(Marketwire - August 05, 2009) -
-- Novartis Vaccines ships doses of seasonal influenza vaccine to the
U.S. market aided by an expedited FDA review
-- Providing 30 million doses of Fluvirin vaccine in the U.S., to support
the annual seasonal influenza vaccination campaign
-- Early delivery of vaccine will allow public health officials to begin
the vaccination campaign weeks ahead of the normal schedule
Novartis Vaccines has started shipping seasonal influenza vaccine to U.S.
healthcare facilities for the 2009-2010 season. The company delivered
Fluvirin® influenza virus vaccine, which has been approved by the U.S.
Food and Drug Administration (FDA), to the U.S. weeks ahead of schedule in
anticipation of the increased demand for seasonal influenza vaccine created
by the current global (A) H1N1 influenza pandemic.
"With the (A) H1N1 influenza pandemic underway, it is important that we
take every possible precaution to help protect U.S. citizens from all
circulating strains of influenza," said Andrin Oswald, CEO of Novartis
Vaccines and Diagnostics. "By receiving the seasonal influenza vaccine
early, physicians and public health officials can better prepare for the
upcoming flu season."
An estimated 36,000 people in the United States die each year from the flu
and another 200,000 are hospitalized. Early arrival of the seasonal
influenza vaccine will also allow public health officials to begin
administering vaccinations weeks ahead of their normal schedule, which is
in accordance with guidelines from the Advisory Committee on Immunization
Practices (ACIP) of the U.S. Centers for Disease Control and Prevention
(CDC). Federal health officials advise that the single best way to protect
against the flu is to get vaccinated each year, and that in general anyone
who wants to reduce their chances of getting the flu can get vaccinated.
Novartis Vaccines will provide the U.S. market with approximately 30
million doses of Fluvirin vaccine, 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):
-- 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
"Novartis Vaccines committed early on that we would not let production of a
pandemic vaccine get in the way of our ongoing commitment to provide
seasonal influenza vaccine for the U.S. market," Oswald said. "We have
been able to meet that promise with the early delivery of Fluvirin to the
U.S. Our next goal will be to bring an (A) H1N1 influenza vaccine for
public health use as soon as possible."
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.
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 and about half of the estimated 70,000 people who die
annually of diabetes and its complications. During the 2007-2008 seasonal
influenza season, 83 children were reported to have died of
influenza-related causes. Of the 63 whose vaccination status was known, 58
(92 percent) were not vaccinated according to recommendations. 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.
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
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.
Disclaimer
The foregoing release contains forward-looking statements that can be
identified by terminology such as "will," "can," "committed," "would,"
"commitment," "goal," "recommends," "recommended," or similar expressions,
or by express or implied discussions regarding Novartis' potential
production output for Fluvirin and A(H1N1) vaccines, and regarding
potential future revenues from Fluvirin vaccine. 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 achieve any particular production output for
its Fluvirin or A(H1N1) vaccines, or indeed that the A(H1N1) vaccine will
be approved for sale in any market. Nor can there be any guarantee that
Fluvirin vaccine will achieve any particular levels of revenue in the
future. In particular, management's expectations could be affected by,
among other things, unexpected regulatory actions or delays or government
regulation generally; unexpected clinical trial results, including
unexpected new clinical data and unexpected additional analysis of existing
clinical data; unexpected manufacturing difficulties or delays; 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. 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' blood testing and
diagnostics business is dedicated to preventing the spread of infectious
diseases through the development of novel blood-screening tools that
protect the world's blood supply.
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 http://www.novartis.com.
