September 16, 2016
By Alex Keown, BioSpace.com Breaking News Staff
GAITHERSBERG, Md. – Shares of Novavax have plummeted more than 82 percent this morning after the company released data that its Phase III trial for its RSV F Vaccine for older adults did not meet its goals, failing to demonstrate “vaccine efficacy.” The trial results are a major blow to the company that was hoping to develop the first RSV vaccine.
Shares of Novavax fell from $8.32 per share at close on Thursday to this morning’s low price of $1.18 per share. Shares are currently trading at $1.48 as of 10:32 a.m.
Gregory Glenn, president of research and development at Novavax, called the trial results surprising and disappointing. In a statement Glenn said the initial review of trial data did “not indicate issues with trial execution, data collection, data integrity, or drug product quality.”The Phase III Resolve trial failed to meet both its primary and secondary endpoints. The primary objective of the Resolve trial was to demonstrate efficacy in the prevention of moderate-severe RSV-associated lower respiratory tract disease. The secondary endpoint was to demonstrate efficacy of the RSV F Vaccine in reducing the incidence of all symptomatic respiratory disease due to RSV.
In his statement, Glenn said the company will investigate “potential root causes” that could have impacted the outcome of this trial. Novavax believes there still remains a path forward for the RSV vaccine, Glenn said.
Novavax’s RSV (respiratory syncytial virus) F vaccine had been fast-tracked by the U.S. Food and Drug Administration. Analysts had predicted that if the drug passed muster and was approved by regulatory agencies, it could yield up to $8 billion in annual revenue and was expected by some to dominate the space held by Pfizer ’s Prevnar 13, which is used to treat pneumococcus. That drug generated $6.3 billion in 2015.
Stanley Erck, president and chief executive officer of Novavax, said that although results from the Phase III trial were “unexpected,” the company believes in the drug candidate “based on the totality of the data from our RSV F Vaccine franchise.”
RSV is a respiratory infectious disease that causes serious infection of the respiratory tract, similar to influenza. For some, RSV may progress in severity, and lead to hospitalization or even death. The spread of RSV occurs annually, with about 2.5 million cases reported annually in the United States. RSV is increasingly being recognized as a significant cause of morbidity and mortality in the population of 64 million older adults. Currently, there is no approved RSV vaccine available. RSV
While the trial failed, in August analysts at The Motley Fool said Novavax maintains “a host of other high-value vaccine candidates” in its pipeline to aid in future stock increases. Prior to Novavax’s announcement, the company had a market value of $2.5 billion, CNBC reported.
