Novavax, a clinical-stage biopharmaceutical company, has entered into a clinical development partnership with PATH to develop its respiratory syncytial virus (RSV) vaccine.
As a part of 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 award approximately $2m on a non-dilutive basis for Novavax’s external clinical development costs of the trial.
Stanley Erck, Novavax president and CEO, 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.
In future, the companies may advance the Novavax’s recombinant RSV fusion (F) protein vaccine candidate with the goal of immunising pregnant women.
With the immunisation, high levels of maternal RSV antibodies will be transmitted to offspring through the placenta before birth thereby providing protection against infection in the early infancy period.
Following the initial study, PATH may 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 plans to make the product affordable and available in low-resource countries.
Kathleen Neuzil, PATH RSV vaccine project director, said: "Based on Novavax’s Phase I clinical trial results, we view this RSV vaccine as a promising candidate to address a very large unmet need in infant populations throughout the world, but particularly in low-resource countries."