Updated on 25 January 2015
Mr Stan Erck, CEO, Novavax
Singapore: Emerging viruses and those with pandemic potential, such as Middle East Respiratory Syndrome (MERS) and Ebola, were an incredibly important global public health issue this past year. Using recombinant nanoparticle technology, Novavax has demonstrated both the ability and agility to rapidly respond to these emerging threats. We announced the publication of significant preclinical data on a vaccine candidate to MERS in April of this year and the first Ebola vaccine candidate based on the 2014 Guinea Ebola strain in October. These programs build on significant momentum from 2013, when we initiated a clinical trial of our H7N9 pandemic influenza vaccine candidate in humans a mere 91 days after the RNA sequence was made available. The encouraging data and speed with which it was obtained was significant enough to merit publication in the New England Journal of Medicine. We expect to initiate a Phase 1 clinical trial of the Ebola vaccine candidate in the first quarter of 2015.
Novavax executed on a number of significant milestones in 2014. We announced the initiation of three key clinical trials of our RSV F-protein vaccine as well as the extension of our partnership with PATH, which partially supports the RSV program. In the second quarter of 2014, we announced data from a RSV F-protein Phase 2 clinical trial in 720 women of childbearing age, establishing a single dose formulation which demonstrated safety and the highest levels of antibodies seen in any previous study. This data formed the basis for dose selection for later trials. Data indicating the RSV F-protein vaccine is safe, potent, and elicits high levels of neutralizing antibodies was published in the journal Vaccine, suggesting that the vaccine provides protection against both homologous strain and heterologous strain viral challenges. Significantly, we received Fast Track Designation from the FDA for RSV F-protein vaccine for protection of infants via maternal immunization, which reflects the FDA's recognition of this important unmet medical need and their support for Novavax's novel approach.
We also received an extension of our BARDA (Biomedical Advanced Research and Development Authority, US Department of Health and Human Services) contract, worth up to $167 million, through September 2016. This contract supports our seasonal and pandemic influenza programs. Finally, Novavax received Fast Track Designation from the FDA for our H7N9 vaccine candidate, underscoring the FDA's recognition of an urgent need for an H7N9 vaccine and the strength of Novavax's H7N9 virus-like particle vaccine candidate.
2015 represents a significant inflection point for Novavax. Respiratory syncytial virus (RSV) preys on the vulnerable, infants, children and the elderly, and is the major cause of hospitalizations of infants 0-12 months. Globally, RSV is the second-leading cause of infant mortality due to infectious disease behind only malaria. We expect to report data on three key clinical trials of our RSV F-protein vaccine in 2015: our maternal study in women in their third trimester of pregnancy to support the development of maternal immunization strategy for protection of infants 0-6 months, our pediatric study in children 6 months to 6 years of age and our study in the elderly over 60 years of age.
We also plan to report data on a phase 2 clinical trial of our recombinant quadrivalent seasonal influenza vaccine candidate. Together, these trials may position Novavax to initiate our first phase 3 clinical trial by the end of 2015, an important final step before receiving FDA approval for our vaccines.
With the independent advancement our RSV vaccine and our seasonal influenza vaccine, we will take the opportunity to explore the combination of these two products into a broad seasonal respiratory vaccine with the initiation of a Phase 1 clinical trial in the first quarter of 2015.
We are proud that we have added over 240 dedicated and talented employees to the Novavax team over the past three years. We look forward to 2015 as a year of continued growth as we advance to a late-stage company and beyond.
While our recombinant protein nanoparticle technology allows us too rapidly respond to emerging threats, we remain focused on executing on a number important milestones including completing the three key clinical trials in our RSV program as well as our quadrivalent seasonal influenza vaccine. Positive results from these programs will position Novavax to potentially advance the development into a phase 3 pivotal study in the elderly in late 2015.
We look forward to another exciting year for the industry. We expect the industry to continue innovate in an effort to create breakthrough products in virtually all fields.