Novartis and Biological E agree to deliver affordable vaccines for typhoid and paratyphoid A fevers to developing world
Novartis International AG /
Novartis and Biological E agree to deliver affordable vaccines for typhoid and
paratyphoid A fevers to developing world
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* License agreement advances a Novartis goal to deliver accessible and
affordable vaccines that address unmet medical need in endemic regions
* More than 21 million cases of typhoid fever and five million cases of
paratyphoid A fever are reported worldwide each year[1]
Basel, Switzerland, July 8, 2013 - Novartis today announced that it has entered
into a development and licensing agreement with Biological E Limited (BioE), a
biopharmaceutical company based in India, for two vaccines to protect against
typhoid and paratyphoid fevers. The agreement advances the Novartis goal to
deliver accessible and affordable vaccines that address unmet medical need in
endemic regions.
In just five years, the Novartis Vaccines Institute for Global Health (NVGH),
part of the Novartis Institutes for BioMedical Research, has developed a typhoid
vaccine with funding by the Fondazione Monte dei Paschi di Siena and Regione
Toscana through the Sclavo Vaccines Association (Italy). In addition, a dual-
acting vaccine with components against both typhoid and paratyphoid fevers is
being developed with on-going support from the Wellcome Trust. Both could reduce
the burden of these diseases in endemic regions.
"NVGH uses its innovative know-how to tackle important problems in public
health," said Don Ganem, VP and Global Head of Infectious Diseases, Novartis
Institutes for BioMedical Research. "BioE has a proven track record in vaccine
manufacture, and capabilities to clinically develop and deliver WHO pre-
qualified affordable vaccines to the developing world. Â We are pleased to be
working with them to address this unmet need."
More than 21 million cases of typhoid fever and five million cases of
paratyphoid A fever are reported worldwide in a year[1], especially in areas
that lack appropriate sanitation and access to clean water. Many victims are
children under the age of two for whom there is no widely available typhoid
vaccine, while no vaccine is available for any age group against paratyphoid
fever.
Under the license, NVGH will transfer technology to BioE, which will have
financial and operational responsibility for manufacturing, further clinical
development, approval and distribution in the developing world. Â The typhoid
vaccine (Vi-CRM197) has achieved Proof of Concept, had successful Phase 2
results, and will be transferred to BioE. A combined typhoid-paratyphoid vaccine
will be transferred once Proof of Concept is completed through early, small-
scale studies in humans to determine safety and immunogenicity. The Wellcome
Trust continues to support the development of the dual-acting vaccine through a
Strategic Award that was awarded in 2009.
"Typhoid and paratyphoid are major causes of life-threatening disease worldwide
and with the emergence of resistance to all of the commonly used antibiotics,
they are becoming increasingly difficult to treat," said Ted Bianco, Director of
Technology Transfer and Acting Director of the Wellcome Trust. "This licensing
deal takes us a step closer to getting much-needed affordable vaccines into the
communities that need them most."
BioE is committed to achieving World Health Organization (WHO) pre-qualification
and fulfill specific obligations to meet Novartis standards[2]. The agreement is
worldwide except for developed countries, where Novartis will retain rights.
Information about typhoid and paratyphoid fevers
The bacteria Salmonella enterica serovar Typhi (S. Typhi) causes typhoid fever
and is a significant public health problem in developing countries where access
to clean water and proper sanitation is limited and causes over 21 million cases
and over 200,000 deaths per year worldwide[1]. S. Paratyphi A causes a
clinically similar disease (paratyphoid fever) and is reported to cause five
million cases in a year[1]. Given limitations of current typhoid vaccines and
increasing antibiotic drug resistance of the bacteria, there is an urgent need
for effective vaccines.
Disclaimer
This press release contains expressed or implied forward-looking statements,
including statements that can be identified by terminology such as "to deliver,"
"goal," "could," "will," "committed," or similar expressions. Such forward-
looking statements reflect the current views of the Group 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
expressed or implied by such statements. These expectations could be affected
by, among other things, risks and factors referred to in the Risk Factors
section of Novartis AG's current Form 20-F on file with the US Securities and
Exchange Commission. Novartis is providing the information in this press release
as of this date and does not undertake any obligation to update it in the
future.
About Novartis Vaccines Institute for Global Health
The mission of the Novartis Vaccines Institute for Global Health is to develop
effective and affordable vaccines for neglected infectious diseases of
impoverished communities. In striving to achieve this mission, NVGH aims to
substantially reduce development risks and cost of new vaccines so that
manufacturers will be able to viably produce and distribute these vaccines to
the public health sector of the developing world. NVGH's role is to undertake
the translational research required to take a laboratory concept through
development to the human Proof of Concept and then to transfer this knowledge to
a manufacturer.
About Novartis
Novartis provides innovative healthcare solutions that address the evolving
needs of patients and societies. Headquartered in Basel, Switzerland, Novartis
offers a diversified portfolio to best meet these needs: innovative medicines,
eye care, cost-saving generic pharmaceuticals, preventive vaccines and
diagnostic tools, over-the-counter and animal health products. Novartis is the
only global company with leading positions in all these areas. In 2012, the
Group achieved net sales of USD 56.7 billion, while R&D throughout the Group
amounted to approximately USD 9.3 billion (USD 9.1 billion excluding impairment
and amortization charges). Novartis Group companies employ approximately
129,000 full-time-equivalent associates and operate in more than 140 countries
around the world. For more information, please visit http://www.novartis.com.
Novartis is on Twitter. Sign up to follow @Novartis at
http://twitter.com/novartis.
References
[1] Bulletin of the World Health Organization 2004; 82:346-353
(http://www.who.int/rpc/TFDisBurden.pdf)
[2] http://www.novartis.com/downloads/corporate-responsibility/responsible-
business-practices/10-principles.pdf
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