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Inside Bavarian Nordic’s late-stage stumbles — and its drive to become a vaccine giant

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Riding a high from sales of its mpox vaccine, Bavarian Nordic strode into 2023 with one major goal in mind — to become one of the largest pure-play vaccine manufacturers in the world.

While the Dutch biotech has focused on vaccines since it was founded in the early ‘90s, it’s largely relied on government contracts, including for its smallpox and mpox shot Jynneos, to stay afloat. And although the approach has proved successful — the company sold almost 5.5 million doses of its mpox vaccine to the U.S. government during the global surge of cases last summer — the business model is “lumpy,” CEO Paul Chaplin said.

“Government contracts are difficult to predict, and the timing is difficult to explain to analysts and investors,” he said. To drive growth, Bavarian pivoted in 2019 toward building a “more traditional, commercial global infrastructure,” buying two GSK vaccines for rabies and tick-borne encephalitis and dedicating its development efforts to infectious disease and cancer vaccines.


“We now have the largest travel commercial portfolio in the globe and that has led us to become a fully integrated, profitable company.”

Paul Chaplin

CEO, Bavarian Nordic


Since then, the transition has been bumpy. In July, for instance, the company dropped out of the respiratory syncytial virus (RSV) vaccine race after its phase 3 trial failed to meet primary endpoints. And just a month later, the biotech ended a phase 3 COVID-19 booster program when it showed limited efficacy against new variants of the virus.

Despite the setbacks, Chaplin said Bavarian is still on track to meet its goal — optimism that’s largely propelled by the extensive travel vaccine portfolio it acquired in a purchase of Emergent BioSolutions earlier this year. Among the deal’s top prospects is a phase 3 vaccine candidate for the mosquito-transmitted chikungunya fever that showed high efficacy in data published last month. For Chaplin, the vaccine represents the next stage of Bavarian’s growth.

Professional headshot of Paul Chaplin

Paul Chaplin, CEO, Bavarian Nordic 

Permission granted by Bavarian Nordic

 

“We now have the largest travel commercial portfolio in the globe and that has led us to become a fully integrated, profitable company,” he said of the Emergent deal, adding that a resurgence in travel demand post-pandemic “bodes well for bringing in new travel vaccines, like chikungunya.”

Here, Chaplin explains the impact of Bavarian’s phase 3 failures, the promise of its chikungunya vaccine candidate and how it fits into the company’s overall strategy for becoming a major vaccine player.

This interview was edited for brevity and style.

PHARMAVOICE: Tell me about the decision to end your RSV program after the phase 3 trial did not meet its primary endpoints.

PAUL CHAPLIN: RSV until very recently has been a bit of a graveyard for companies. We had a candidate that looked highly promising, so we went into phase 3 with some confidence. And unfortunately, as can often happen, when we read out the trial, we got mixed results. There were signals of efficacy around 50% but when we compared that to some of the earlier readouts from GSK and Pfizer, that was not in the same range that was competitive, and therefore we decided to close the program. It’s a setback in terms of our future revenue growth, but the future of Bavarian Nordic didn’t rely on RSV.

You also dropped your COVID-19 booster after poor results. How are you adjusting your short-term strategy as a result of both losses?

Our future strategy hasn’t really changed. We’re a fully integrated vaccine company that’s profitable. We have a vision to continue to grow and become one of the largest pure-play vaccine companies. Depending on how you measure that, we’re already there in terms of the number of products and the profit margin that we’re recording. I would say our strategy is to continue on the commercial journey and add more products, either through additional acquisitions or through organic growth, and bring other products like chikungunya through phase 3 to launch.

Speaking of your chikungunya vaccine, it read out phase 3 results in August. What are some of the next steps to submit the vaccine to the FDA?

We’re heading towards submitting in ‘24. The readout was highly successful, but we still have to complete other studies which we’re doing. Before you can file you also have to show that you’ve got the commercial manufacturing under control and that’s currently being finalized as well. So everything’s going according to plan for next year.

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