Once described as having the potential to become "the best-selling vaccine in the history of vaccines", the Novavax fusion protein nanoparticle against respiratory syncytial virus missed another phase 3 trial, causing loss during his action about two-thirds of his balance. value in the trade before the sale.
In September 2016, Novavax's shares fell after a placebo-controlled study conducted among 12,000 adults aged 60 and older did not achieve its prevention effectiveness goals. RSV-related disease in the lower respiratory tract. The company removes 30% of its workforce two months later.
Now, after receiving a $ 89.1 million grant from the Bill & Melinda Gates Foundation, the RSV ResVax recombinant vaccine has missed its primary endpoint for maternal infant immunization. The study involving 4,600 pregnant women, with the vaccine administered in the third trimester, aimed to determine whether immunity could be transmitted after birth and for at least the first 90 days of life.
While the well-tolerated vaccine was only 39% effective against the main objective of the study, namely the prevention of clinically significant RSV-related lower respiratory tract infections, Novavax cited secondary data. showing that hospitalizations for all causes of LRTI were reduced by 25%. Efficacy of 44% against RSV LRTI hospitalizations.
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RSV is the leading cause of hospitalizations in infants in the United States, and comes just behind malaria as a cause of infant death worldwide, with lifelong susceptibility being common, according to Novavax. In May 2018, leaders said the vaccine could reach $ 1.5 billion in sales – half of which would come from the US and before adding potential revenue from middle and low-income markets – and that the company had begun pre-marketing measures.
Describing the secondary objectives of the new study as the first phase 3 efficacy observed with any RSV vaccine – and indicating that "exploratory assessment criteria and post-hoc analyzes" still suggest a Potential to improve global health, Novavax said its next steps were to take place in the United States and North America. European regulators will discuss ways to access the permit.
"We are very encouraged by the fact that Novavax's maternal RSV vaccine has reduced severe RSV hypoxemia by 60% in the first months of life, and we believe that this vaccine has considerable potential for reducing RSV-associated deaths in young babies, "said Keith Klugman, director of the Gates Foundation pneumonia program, said in a statement. The 60% figure comes from a predefined exploratory analysis and includes additional data from hospitalization records, while the secondary efficacy endpoint from the study of the same measure was 48%.
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Progress in RSV therapy has also been slow, with Johnson & Johnson revealing late last year that he received US $ 630 million after his Phase 2b trial of oral lumicitabine therapy were suspended last August. The depreciation followed the $ 1.75 billion takeover of Alios' antiviral developer by J & J with lumicitabine, also known as AL-8176, serving as the main drug in the deal.
In a report filed with the SEC last October, J & J announced that it would "re-value the book value of the current research and development asset AL-8176" and "monitor the additional write-down of the intangible asset of 900 million US dollars.