Novartis to enter Japan vaccines market through agreement for
Haemophilus Influenzae Type B (Hib) vaccine
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* Marketing and distribution agreement with Takeda Pharmaceuticals
for Vaxem-Hib® is another step in Novartis global vaccines
expansion strategy.
* Takeda will become the exclusive partner for Vaxem-Hib in Japan
and pay Novartis 100 million Yen and milestone and royalty
payments.
* Hib infection is responsible for an estimated 386,000 deaths per
year worldwide.
Basel, May 26, 2009 - Novartis announced today that it has entered an
agreement with the Takeda Pharmaceutical Company in Japan for the
distribution of the Novartis Vaxem-Hib® vaccine for the prevention of
infection caused by Haemophilus influenzae type B (Hib). Through this
agreement, Novartis will manufacture the vaccine and supply it to
Takeda, which will obtain exclusive rights to license, market and
distribute the vaccine in Japan.
The WHO estimates that Hib is responsible for some three million
serious illnesses and an estimated 386,000 deaths per year world
wide, chiefly through meningitis and pneumonia[1]. Every year in
Japan, 7.5 per 100,000, or more than 450 children, under the age of
five are affected by Hib meningitis[2]. Almost all victims are
children under the age of five[1].
"Novartis is committed to bringing Vaxem-Hib® to Japan as soon as
possible to help protect Japanese children from Meningitis and other
Hib induced infectious diseases through this strategic partnership
with Takeda," said Dr. Andrin Oswald, CEO of Novartis Vaccines and
Diagnostics. "Vaxem-Hib® is the first of many vaccines that Novartis
hopes to bring to Japan to help improve public health and address
unmet medical needs."
Vaxem-Hib® will mark Novartis entrance into the Japan vaccines market
and is part of Novartis Vaccines global expansion strategy. Japan is
the world's third largest vaccine market valued at USD 640 million
and is expected to grow further.
With this agreement Takeda will become the exclusive partner for
Vaxem-Hib in Japan, and will be responsible for conducting clinical
trials and submitting a New Drug Application (NDA). Following
approval, Takeda will label the product and sell the vaccine under
the Novartis brand name. Under the terms of the deal, Takeda will pay
Novartis 100 million Yen upfront and will be responsible for paying
milestones and royalties in accordance with development and sales of
the product.
About Haemophilus Influenzae Type B
Hib is a severe bacterial infection, occurring primarily in infants
and children under 5 years[3]. It is commonly found in the noses and
throats of healthy individuals living in regions where vaccination is
not carried out[2]. Hib disease is spread through the air by
coughing, sneezing, and even breathing. If the bacteria spread to the
lungs or bloodstream, the child can get meningitis (inflammation of
the covering of the brain), pneumonia, epiglottitis (inflammation in
the throat), arthritis, or other problems. A child who is infected
can spread the disease to others for as long as the bacteria remain
in the body[3].
Symptoms of Hib are meningitis, pneumonia, sepsis, epiglotittis (a
severe throat infection), skin infections, and arthritis.
Complications of the disease can lead to Hib meningitis (death in one
out of 20 children, and permanent brain damage in 10% - 30% of the
survivors)[3].
About Vaxem-Hib
Vaxem-Hib is a vaccine indicated for vaccination against Haemophilius
Influenzae Type B in children less than five years of age.
Disclaimer
The foregoing release contains forward-looking statements that can be
identified by terminology such as "to enter," "strategy", "will,"
"committed," "hopes," "expected," "can," or similar expressions, or
by express or implied discussions regarding potential Japanese
marketing approvals for Vaxem-Hib, potential future agreements to
sell additional Novartis vaccines in Japan or regarding potential
future revenues from Vaxem-Hib or other Novartis vaccines in Japan.
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 Vaxem-Hib will be approved for sale in Japan. Nor can
there be any guarantee that Novartis will reach agreements to market
any other vaccines in Japan. Neither can there be any guarantee that
Vaxem-Hib or any such other vaccines 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;
competition in general; government, industry and general public
pricing pressures; the company's ability to obtain or maintain patent
or other proprietary intellectual property protection; 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, cost-saving generic pharmaceuticals, preventive
vaccines, diagnostic tools 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
98,000 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.] World Health Organization. Haemophilus influenzae type B (HiB).
http://www.who.int/mediacentre/factsheets/fs294/en/. Accessed May 12,
2009
[2.] Kato et al. Japan Medical Journal, No.4370, p77
[3.] Centers for Disease Control and Prevention. Parents Guide to
Childhood Immunizations (Hib).
http://www.cdc.gov/vaccines/vpd-vac/hib/downloads/pg_why_vacc_hib-508.pdf.
Accessed May 14, 2009.
# # #
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