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Novavax, PATH sign RSV vaccine clinical development partnership

Novavax and PATH have signed a clinical development partnership to develop the respiratory syncytial virus (RSV) vaccine.

According to the collaboration, Novavax’s Phase II trial scheduled for second half of 2012 will be designed to evaluate the immune response to different doses of the vaccine candidate in women of childbearing age.

PATH will fund approximately $2m on a non-dilutive basis for Novavax’s external clinical development costs of the trial.

The recombinant RSV fusion (F) protein vaccine candidate might then be advanced by immunising pregnant women so as to transmit high levels of maternal RSV antibodies to offspring through the placenta before birth thereby providing protection against infection in the early infancy period.

Novavax president and CEO Stanley Erck said the partnership with PATH complements the company’s strategy to develop this RSV vaccine for multiple indications in affected patient populations, in all markets throughout the world with multiple partners.

"We estimate that the world-wide market for an RSV vaccine could exceed $5 billion," Erck added.

PATH may then elect to continue to partner with Novavax and provide support for the external clinical development costs through commercialisation for the indication.

Novavax will retain global rights to commercialise the product and considers making the product affordable and available in low-resource countries.