Novartis and Biological E, a biopharmaceutical company based in India, have entered into an agreement that aims to deliver affordable and accessible vaccines for typhoid and paratyphoid A fevers to developing countries and thereby address the unmet medical need in endemic regions. 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). In addition, a dual-acting vaccine with components against both typhoid and paratyphoid fevers is being developed with ongoing support from the Wellcome Trust.
The press release stated that under the license, NVGH will transfer technology to Biological E, who will have financial and operational responsibility for manufacturing, further clinical development, approval and distribution in the developing world. The terms of the agreement apply worldwide except for developed countries, where Novartis retains its rights.
Proof of concept has been achieved with the typhoid vaccine (Vi-CRM197), with successful Phase II results. The technology for this vaccine will be transferred to Biological E. The combined typhoid-paratyphoid vaccine will be transferred after proof of concept has been demonstrated through early, small-scale safety and immunogenicity studies in humans. The Wellcome Trust continues to support the development of the dual-acting vaccine through a Strategic Award that was awarded 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 a step closer to getting much-needed affordable vaccines into the communities that need them most."