Novavax, Inc. announced the continuation of their partnership with PATH to develop Novavax' RSV (respiratory syncytial virus) vaccine for maternal immunization. Under this amendment, PATH will provide Novavax approximately $3.5 million in funding to support the ongoing Phase II dose-confirmatory clinical trial in women of childbearing age, initiated in October 2013. Under this partnership, Novavax and PATH will also initiate planning activities for clinical development of the vaccine in low-resource countries.
Data from the ongoing Phase II clinical trial will provide additional evidence of the vaccine candidate's safety and establish the appropriate dose to be used in a follow-on clinical trial in pregnant women. By immunizing pregnant women, Novavax believes that high levels of protective maternal RSV antibodies will be transferred to their offspring through the placenta before birth, providing protection in early infancy when RSV infection is most dangerous.
Under this partnership, PATH and Novavax may elect to continue to collaborate on additional clinical trials to further develop Novavax' RSV vaccine for maternal immunization in low-resource countries. Novavax retains global rights to commercialize the product and will support PATH in its goal to make the product affordable and available in low-resource countries.
"PATH, an internationally recognized innovative global health organization, continues to support a key portion of the development expenses for our RSV vaccine candidate. We are gratified by PATH's continued funding of this vaccine development program, which has the potential to dramatically improve pediatric health worldwide," said Stanley C. Erck, President and CEO of Novavax.
"We are pleased to be working with Novavax to support the development of a maternal RSV vaccine that has the potential to protect infants in low-resource countries during the critical early months of life," said Dr. John Donnelly, director of PATH's RSV vaccine project.
Respiratory syncytial virus (RSV) is one of the most common causes of lower respiratory tract infection among young children, both globally and in the United States. The majority of cases of severe RSV disease occur in otherwise healthy children. It is estimated that there are 64 million cases of RSV disease worldwide each year, resulting in 160,000 deaths. In the U.S., RSV causes as many as 172,000 annual hospitalizations among children younger than 5 years old, with the vast majority of these occurring in infants less than six months of age. Maternal immunization for the protection of young infants against infectious diseases has been successfully employed to eliminate 92% of neonatal tetanus cases globally, and in the U.S. is currently used to prevent whooping cough and influenza. Currently, there is no approved vaccine against RSV.
Novavax, Inc. (Nasdaq:NVAX) is a clinical-stage biopharmaceutical company creating novel vaccines and vaccine adjuvants to address a broad range of infectious diseases worldwide. Using innovative proprietary recombinant protein nanoparticle vaccine technology, the company produces vaccine candidates to efficiently and effectively respond to both known and newly emergent diseases. Additional information about Novavax is available on the company's website, novavax.com.
PATH is an international nonprofit organization that transforms global health through innovation. We take an entrepreneurial approach to developing and delivering high-impact, low-cost solutions, from lifesaving vaccines, drugs, diagnostics, and devices to collaborative programs with communities. Through our work in more than 70 countries, PATH and our partners empower people to achieve their full potential. For more information, please visit www.path.org.