Novartis, BioE in typhoid vaccine deal

Novartis has entered into a development and licensing agreement with India-based Biological E Limited (BioE) for two vaccines to protect against typhoid and paratyphoid fevers. Novartis has a goal to deliver accessible and affordable vaccines that address unmet medical need in endemic regions and this new collaboration further advances the pharma company towards its goal.

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). The typhoid vaccine (Vi-CRM197) has already achieved Proof of Concept and has had successful Phase 2 clinical trial results, and will be transferred to BioE.

Under terms of the agreement, NVGH will transfer technology to BioE, who will then have financial and operational responsibility for manufacturing, further clinical development, approval and distribution in the developing world.

"NVGH uses its innovative know-how to tackle important problems in public health. 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. We are pleased to be working with them to address this unmet need."

Don Ganem, VP and Global Head of Infectious Diseases, Novartis Institutes for BioMedical Research.

BioE is committed to achieving World Health Organization (WHO) pre-qualification and fulfill specific obligations to meet Novartis standards. The agreement is worldwide except for developed countries, where Novartis will retain rights.

There are approximately 21 million cases of typhoid fever and five million cases of paratyphoid A fever reported globally in a year. Many victims are children under the age of two as there is no widely available typhoid vaccine. No vaccine is available for any age group against paratyphoid fever.