Novavax, PATH to produce vaccines for low-income countries

Monday, July 23, 2012 11:26 AM

Novavax, a clinical-stage biopharmaceutical company based in Rockville, Md., has partnered with international non-profit organization PATH to develop a vaccine against respiratory syncytial virus (RSV) — the most common cause of childhood respiratory infection globally — for infants in low-income countries with a high disease burden.

“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,” said Dr. Kathleen Neuzil, director of PATH’s RSV vaccine project.

The vaccine is designed to provide immunization to infants upon administration to the mother. PATH has awarded Novavax approximately $2 million for initial funding to partially support a phase II dose-ranging clinical trial in women of childbearing age planned for the second half of this year. Following this initial study, PATH may elect to continue to partner with Novavax and provide support for 50% of the external clinical development costs through commercialization for this indication. Novavax will retain global rights to commercialize the product and has made a commitment to make the product affordable and available in low-resource countries.

“We are very proud to partner with PATH, an internationally recognized organization transforming global health through innovation, on our RSV vaccine candidate that has the potential to impact health conditions in the developing world. This partnership further validates the promise of our recombinant nanoparticle vaccines,” said Stanley C. Erck, president and CEO of Novavax. “This partnership with PATH complements our corporate 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 also noted that Novavax is interested in achieving higher distribution through multiple partnerships to help garner a majority of the estimated $5 billion RSV treatment market.

Currently, there are no approved RSV prophylactic vaccines available.

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