Novavax has pushed again its timeline and can apply for authorisation of its vaccine within the UK, US and Europe within the third quarter of the 12 months as the corporate struggles to rapidly collate the info required for submission.
“It’s only a lengthy course of,” Stanley Erck, chief govt of Novavax, instructed the Monetary Instances. “Our steering had been that we’d get the challenge carried out by the second quarter and I’m now saying … we will’t get all of it carried out by the top of June so it’s going to slide into the third quarter sadly.”
His feedback got here because the biotech reported first-quarter revenues of $447m, surpassing analysts’ expectations of $234m and surging past the $3m price of gross sales that it booked in the identical interval final 12 months.
The US and UK are usually not reliant on the Novavax jab for immunising their populations as a result of orders from different authorised drugmakers have been met. But when authorised, the protein-based vaccine would enhance the worldwide provide of jabs and profit growing nations, particularly as a result of the jab might be simply saved in a fridge.
Novavax’s two-dose vaccine has proved 96 per cent efficacy in opposition to the unique pressure of coronavirus and 86 per cent efficacy in opposition to the variant first detected within the UK.
“It’s the quantity of labor,” Erck mentioned in regards to the delay, including that the corporate has gone from a workers of 150 to 900 over the previous 12 months. “I should have 100 consultants which might be engaged on it.”
Novavax’s UK medical trial knowledge are full however it’s engaged on gathering manufacturing knowledge that may present the drugmaker can safely and repeatedly make the identical vaccine doses. Its US medical trial is anticipated to complete within the second quarter of the 12 months.
The Maryland-based firm made a internet lack of $223m within the three months to March. Analysts had anticipated a internet lack of $256m.
Erck mentioned the biotech has struggled with a scarcity of uncooked supplies together with luggage, filters and cell tradition media. He mentioned it was “painful” that one Novavax plant didn’t function for 3 weeks due to a scarcity of supplies, which has now been resolved. If all its vegetation are working at full capability, Novavax ought to be capable of make 150m doses each month, he added.
Novavax’s share worth has rocketed almost 4,000 per cent because the begin of 2020. Its shares rose 3 per cent in after-market buying and selling on Monday after closing 9 per cent decrease.