Novartis, Biological E Limited in agreement for two vaccines to protect against typhoid and paratyphoid fevers

Novartis announced a development and licensing agreement with Biological E Limited (BioE, India) ) for two vaccines to protect against typhoid and paratyphoid fevers. Under the license, Novartis Vaccines Institute for Global Health (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) involved 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. BioE said it is committed to achieving WHO pre-qualification and fulfill specific obligations to meet Novartis standards. The agreement is worldwide except for developed countries, where Novartis will retain rights.