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Ixiaro® vaccine receives Marketing Authorization in Europe for the prevention of Japanese Encephalitis

Corporate news announcement processed and transmitted by Hugin AS.
The issuer is solely responsible for the content of this
announcement.
----------------------------------------------------------------------
--------------




* First major achievement from strategic alliance between Novartis
Vaccines and Intercell announced in 2006

* Ixiaro strengthens Novartis Vaccines travel portfolio which now
includes vaccines against Japanese Encephalitis, rabies and
tick-borne encephalitis

* Japanese Encephalitis is a potentially life-threatening disease
for travelers from Europe to Asia


Basel, April 2, 2009 - The European Commission has granted Marketing
Authorization to Ixiaro® vaccine for the prevention of Japanese
Encephalitis (JE). JE, a mosquito-borne flaviviral infection,
results in 10,000-15,000 deaths annually[1],[2] and is a potentially
life-threatening disease for travelers to Asia.

Ixiaro was developed to provide a well-tolerated, effective and
convenient vaccine against JE, suitable for administration to
travelers who wish to reduce their risk of acquiring the disease.
Until now there has not been a licensed Japanese Encephalitis vaccine
in Europe. JE is highly prevalent in Asia. It has occurred from the
islands of the Western Pacific in the east to Pakistan in the west,
and from far Eastern Russia and Korea in the north to Northern
Australia in the south.

"Asia is a very popular travel destination for Europeans. Since JE
is spread by mosquitoes, the threat to travelers is unpredictable,"
said Dr. Andrin Oswald, CEO of Novartis Vaccines and Diagnostics.
"Vaccination is the most effective preventive measure against the
disease and Ixiaro will address an unmet medical need for travelers
from Europe to Asia."

Ixiaro was developed by Intercell AG. Novartis and Intercell have a
strategic alliance that provides Novartis with the commercialization
rights to Ixiaro. On December 18, 2008, the Committee for Medicinal
Products for Human Use (CHMP) recommended to grant marketing
authorization to Ixiaro. The European Commission has granted
marketing authorization for the 27 countries of the European Union,
as well as Norway and Iceland. Ixiaro vaccine also has received
marketing authorization in Australia and received FDA approval in the
United States on March 30, 2009. Further pediatric studies with the
vaccine are planned.

Ixiaro Pivotal Study Details
A total of 5,102 subjects have participated in eight Ixiaro clinical
trials. A randomized, multicenter, observer-blinded Phase III study
was conducted to evaluate the immunogenicity of two doses of Ixiaro
compared to three doses of the currently licensed vaccine (in the US)
in healthy adults.

The primary objective of the study was to demonstrate non-inferiority
of Ixiaro to JE-Vax®[9] in terms of immunogenicity at day 56.
Secondary objectives included the safety and local tolerability of
both vaccines. Ixiaro was found to be highly immunogenic, resulting
in protective antibody titers in 99% of subjects following two
doses[4]. The immune response following vaccination with Ixiaro was
sustained at six months, with 95% of the 181 subjects maintaining
protective antibody titers. Eighty-three percent (83%) of subjects
still maintained protective antibody levels after one year[7].

In addition, a multicenter, randomized, double-blind Phase III study
was conducted in 2,675 healthy adults to assess the safety and
tolerability of Ixiaro compared with placebo injections. Ixiaro was
found to be well tolerated and no allergic reactions were observed.
Ixiaro was found to have a similar safety profile to placebo and a
statistically significantly better local tolerability profile than
JE-Vax® [5],[6],[9].

About Ixiaro Vaccine
Ixiaro is indicated for active immunization against JE virus for
persons 18 years of age and older. Ixiaro is a purified inactivated
state-of-the-art JE vaccine that uses cell culture technology. It
provides a good immune response while being well tolerated. It does
not contain thiomersal, gelatin or any other stabilizers or
preservatives in its formulation. The vaccine is provided as a
ready-to-use liquid formulation in pre-filled syringes and is
administered in two doses 28 days apart.

On June 13, 2006, Novartis and Intercell announced that Novartis
Vaccines had obtained worldwide marketing and distribution rights to
the vaccine with the exception of Australia, Korea, Japan and certain
other Asian markets. Ixiaro complements the Novartis Vaccines
portfolio of travel vaccines which includes: Rabipur®/RabAvert®
vaccine, protection against rabies; Typhoral L® vaccine, an oral
typhoid vaccine and HAVpur® vaccine for the prevention of Hepatitis
A.

About Japanese Encephalitis (JE)
Japanese Encephalitis (JE) disease is an acute inflammatory condition
of the brain and spinal cord caused by the Japanese encephalitis
virus (JEV). Most JE virus infections are mild (fever and headache)
or without apparent symptoms, but approximately one in 300 infections
results in severe disease characterized by rapid onset of high fever,
headache, neck stiffness, disorientation, coma, seizures, spastic
paralysis and death. The fatality rate is approximately 30% and as
many as 50% of those who survive suffer from long term persistent
neurological sequelae[2],[3]. In areas where the JE virus is common,
encephalitis occurs mainly in young children because older children
and adults are likely to have acquired natural immunity (through
infection) or have been vaccinated. JE is a leading cause of viral
encephalitis in Asia with 30,000 to 50,000 clinical cases reported
annually[3].

Japanese encephalitis virus is only transmitted by certain types of
mosquitoes (most commonly Culex tritaeniorhynchus). These mosquitoes
are usually found in rural rice-growing areas of Asia, but can also
be found at the outskirts of cities. The mosquitoes become infected
by feeding on domestic pigs and wild birds that are infected with the
Japanese encephalitis virus. Infected mosquitoes then transmit the
Japanese encephalitis virus to other pigs and water birds and also to
humans during feeding[8]. The nature of the JE life cycle means it is
not possible to eradicate JE.

The transmission of JE is linked to the seasonality of the mosquitoes
in these areas. JE is transmitted seasonally in large areas of Asia,
but in some locations may be transmitted year round. Many areas with
tropical climates hold a potential for year round transmission and,
elsewhere, peak periods of increased viral transmission follows
monsoon seasons and irrigation associated with rice cultivation.
Approximately 3 billion people live in areas at risk of the disease.
Novartis Vaccines is committed to educating travelers and healthcare
providers about the risk of acquiring JE during travel and about
protective modalities, including Ixiaro vaccine.


Disclaimer
The foregoing release contains forward-looking statements that can be
identified by terminology such as "potentially," "will," "planned,"
"committed," "awaiting," or similar expressions, or by express or
implied discussions regarding potential new indications or marketing
approvals for Ixiaro or regarding potential future revenues from
Ixiaro. 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 with
Ixiaro to be materially different from any future results,
performance or achievements expressed or implied by such statements.
There can be no guarantee that Ixiaro will be approved for any
additional indications or in any additional markets. Nor can there be
any guarantee that Ixiaro will achieve any particular levels of
revenue in the future. In particular, management's expectations
regarding Ixiaro 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;
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 Chiron. 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 AG 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, preventive vaccines, diagnostic tools,
cost-saving generic pharmaceuticals and consumer health products.
Novartis is the only company with leading positions in 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 96,700 full-time-equivalent associates and operate in
more than 140 countries around the world. For more information,
please visit http://www.novartis.com.

References
[1] PATH. JE in depth. http://www.path.org/projects/JE_in_depth.php
2008
[2] Centers for Disease Control and Prevention. Travelers' Health:
Yellow Book; Chapter 4, Japanese Encephalitis.
http://www.cdc.gov/travel/yellowBookCH4-JapaneseEncephalitis.aspx2007

[3] http://cdc.gov/ncidod/dvbid/jencephalitis/facts.htm
[4] C - Tauber, E. Kollaritsch, H. Korinel, M. et al. Safety and
immunogenicity of a Vero-cell derived, inactivated Japanese
encephalitis vaccine: a non-inferiority, Phase III, randomized
control trial Lancet 370[9602], 1847-1853. 1-12, 2007
[5] Tauber E, Kollaritsch H, von Sonnenburg F et al. Randomized,
Double-Blind, Placebo-Controlled Phase 3 Trial of the Safety and
Tolerability of IC51, an Inactivated Japanese Encephalitis Vaccine.
J Infect Dis 2008; 198:493-499
[6] Dubuscgar-Kastner, K., Kaltenboeck, A., Schuller, E. et al. Six
months Safety of a Vero-cell culture derived Japanese Encephalitis
Vaccine, IXIARO, IC51, across Phase 3 trials and in a long
term-follow up cohort. Abstracts of the 57th American Society for
Tropical Medicine and Hygiene annual meeting, New Orleans, LA, USA,
December 7-11, 2008
[7] Schuller, E., Jilma, B., Voicu, V. et al. Long-term
immunogenicity of the new Vero cell-derived, inactivated Japanese
encephalitis virus vaccine IC51: six and 12 month results of a
multicenter follow-up phase 3 study. Vaccine. 2008. Aug
12;26(34):4382-6
[8] Solomon, T, Mallewa M. Dengue and other emerging flaviviruses. J
Infect 2001;42:104-115
[9] Produced by The Research Foundation for Microbial Diseases of
Osaka University, BIKEN in Japan


# # #
Novartis Media Relations


Central media line : +41 61 324
2200
Eric Althoff Paul Newman
Novartis Global Media Relations Novartis Vaccines and Diagnostics
+41 61 324 7999 (direct) +1 (617) 871-7931 (direct)
+41 79 593 4202 (mobile) +1 (617) 710-8953 (mobile)
eric.althoff@novartis.com paulc.newman@novartis.com


e-mail: media.relations@novartis.com

Novartis Investor Relations


Central phone: +41 61 324 7944
Ruth Metzler-Arnold +41 61 324 9980 North America:
Pierre-Michel +41 61 324 Richard Jarvis +1 212 830
Bringer 1065 2433
John Gilardi +41 61 324 3018 Jill Pozarek +1 212 830
2445
Thomas +41 61 324 8425 Edwin Valeriano +1 212 830
Hungerbuehler 2456
Isabella Zinck +41 61 324 7188

e-mail: e-mail:
investor.relations@novartis.com investor.relations@novartis.com



--- End of Message ---

Novartis International AG
Posfach Basel

WKN: 904278; ISIN:
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