Novartis has entered into a development and licensing agreement with Biological E (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 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. 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.
More than 21 million cases of typhoid fever and five million cases of paratyphoid A fever a year are reported worldwide, especially in areas that lack sanitation and access to clean water. Many victims are children under age two for whom there is no widely available typhoid vaccine, while no vaccine is available for any age group against paratyphoid fever.
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 II 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 given 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 closer to getting affordable vaccines into the communities that need them most."