Bavarian Nordic has licensed rights to its respiratory syncytial virus (RSV) vaccine in China and certain other Asian markets to Shanghai’s Nuance Pharma in a $225 million deal.
The agreement, which also covers South Korea, Taiwan and certain markets in Southeast Asia, will see Nuance take the lead on a phase 3 trial of the MVA-BN RSV vaccine in China that will run separately to Bavarian Nordics own pivotal trial.
The Danish company has received an upfront payment of $12.5 million, with another $212.5 million tied to clinical, regulatory, and commercial milestones as well as royalties on sales if MVA-BN RSV is launched in those markets.
The agreement gives Bavarian Nordic a leg-up in the big Chinese market, as it tried to keep pace with heavyweight rivals in the RSV vaccine category closer to home.
The company’s own 20,000-subject phase 3 trial aimed at securing FDA approval for MVA-BN RSV is due to get underway in the next few weeks, but rival shots from GlaxoSmithKline, Pfizer and Johnson & Johnson are already in phase 3 trials.
GSK and Pfizer are both expecting a readout for their vaccines in older adults in the first half of this year, with J&J’s trial due to report in 2023. GSK’s jab has however run into trouble in the maternal immunisation setting, halting three trials while it investigates a safety signal.
mRNA vaccine specialist Moderna has also recently entered the running, starting a phase 3 trial in people aged 60 and over last month, hoping to follow the breakneck speed of development it displayed with its COVID-19 shot.
With Bavarian Nordic likely to be playing catch-up with its vaccine in the US, unlocking access to the massive Chinese market could be a canny move. The company estimates that the Chinese target population for an RSV vaccine to be nearly 400 million people aged 60 years or older.
Bavarian Nordic CEO Paul Chaplin said that Nuance’s “regional presence combined with a strong leadership and focus on respiratory diseases provides a unique first-to-market opportunity for MVA-BN RSV to fulfil the unmet need for a vaccine to prevent severe disease from RSV infections in the aging Chinese population.”
In mid-stage trials, MVA-BN RSV achieved a significant reduction in viral load in vaccinated subjects compared to placebo, with a reduction in symptoms associated with RSV infection. The shot had a top-line protective efficacy against symptomatic RSV infection of 79%.
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