Collaboration in India for Typhoid/Paratyphoid Vaccine Development

Partnership objective

A collaboration to deliver affordable vaccines for typhoid and paratyphoid A fevers to low-and-middle income coutries.

Given limitations of current typhoid vaccines and increasing antibiotic drug resistance of the bacteria, there is an urgent need for effective vaccines. Given limitations of current typhoid vaccines and increasing antibiotic drug resistance of the bacteria, there is an urgent need for effective vaccines. Copyright Novartis

What are the health needs and challenges?

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. S. Paratyphi A causes a clinically similar disease (paratyphoid fever) and is reported to cause five million cases in a year.

Given limitations of current typhoid vaccines and increasing antibiotic drug resistance of the bacteria, there is an urgent need for effective vaccines. Many victims of these diseases 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.

Description of partnership activities and how they address needs and challenges

Novartis 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.

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.  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.

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.

Summary of impact and forward looking information

The typhoid vaccine (Vi-CRM197) has achieved successful clinical proof-of-concept and Phase 2 clinical trials and is now in the process of being transferred to BioE. A combined typhoid-paratyphoid vaccine that is still undergoing testing at NVGH will be transferred to BioE once clinical proof-of-concept will be completed through early, small-scale human studies to determine safety and immunogenicity.

On 2 March 2015, Novartis announced the completion of a series of transactions with GlaxoSmithKline plc (GSK), including the divestiture of the Novartis non-influenza Vaccines business to GSK.

Partnership information

Company(ies) Novartis

Partner(s) Biological E Limited (BioE), Wellcome Trust

Type of Partner(s) Generic Manufacturers, NGOs

Therapeutic Focus Vaccine-Preventable Diseases

Disease(s) Paratyphoid fever, Typhoid Fever

Program Type(s) Availability of Treatment - Differential Pricing, Availability of Treatment - Technology Transfer - Manufacturing and Entrepreneurial Know-How, Prevention Programs - Vaccines, Research & Development - Development of Treatments

Targeted Population(s) Children, Marginalised / Indigenous People, Patients in needs of treatment, People with low income

Region(s) South Asia

Number of Countries 1

Country(ies) India

Start Date 2013

More information Novartis Newsroom

Completed date 2015

« This licensing deal takes us a step closer to getting much-needed affordable vaccines into the communities that need them most. »

Ted Bianco, Director of Technology Transfer and Acting Director of the Wellcome Trust