Novartis is handing off two new vaccines to India’s Biological E for manufacturing, further clinical development, approval, and distribution in the developing world.
The Novartis Vaccines Institute for Global Health is first transferring to BioE a mid-stage typhoid fever vaccine, to be followed by an early-stage typhoid-paratyphoid fever vaccine, once early proof-of-concept studies are complete.
More than 21 million cases of typhoid fever and five million cases of paratyphoid A fever are reported worldwide a year, especially in areas that lack appropriate sanitation and access to clean water, according to the World Health Organization. There is currently no vaccine against paratyphoid fever.
The deal provides BioE with financial and operational responsibility for the vaccines, although specific financial terms have not been disclosed. Novartis retains rights to the vaccines in developed countries, for which it already produces various travel and other vaccines.
“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,” says Don Ganem, vice president and global head of infectious diseases for Novartis’ Institutes for BioMedical Research.
The Novartis Vaccines Institute developed the typhoid vaccine with funding from Italy’s Fondazione Monte dei Paschi di Siena and Regione Toscana through the Sclavo Vaccines Association. The dual-acting vaccine with components against both typhoid and paratyphoid fevers is being developed with support from the Wellcome Trust.
“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,” says 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.”
July 09, 2013