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Bavarian Nordic will initiate phase III trials with or without partner

Bavarian Nordic has enough money for financing a comprehensive phase III study with its RSV vaccine for approximately USD 100 million alone - unless an attractive partner expresses interest before summer.

Adm. direktør Paul Chaplin, Bavarian Nordic

When the virus- and flu season begins next autumn, Danish Bavarian Nordic is ready for vaccinating thousands of participants in an upcoming phase III trial with its vaccine against Respiratory Syncytial Virus (RSV). The company is prepared to conduct the study alone although the costs might amount to USD 100 million.

CEO of Bavarian, Paul Chaplin, is not in a rush to find a partner for the pivotal study.

"I need a commercial partner but not necessarily a partner for the phase III trial. The longer I keep the asset, the more valuable it will be for an investor in the end. If we receive a fantastic offer from an investor before phase III, we enter a collaboration. Otherwise, we initiate phase III alone," he says to MedWatch.

According to Bavarian's first interim report for 2019, the company is currently good for DKK 2.2 billion (approximately USD 328.8 million). However, the firm maintains its expectations of a so-called cash preparedness of approximately DKK 1.6 billion (USD 246 million) by the end of the year due to investments in research and development and the establishment of a new fill/finish manufacturing line.

Expensive study ahead

Although the final cost of the upcoming trial is still uncertain, Chaplin assures that Bavarian has resources for covering the expenses.

"We are still negotiating the final details about the trial with FDA [the US Food and Drug Agency, ed.] but in total, it will cost USD 80-120 million. We can easily afford the study without having to raise more funds or worry about anything. So, we definitely move into phase III next year. One way or another. With or without a partner," says the CEO.

The relatively high cost of the study is due to the need to vaccinate 12,000-18,000 people. Bavarian Nordic and FDA will have more meetings during summer and afterwards settle the final details and the price.

The Danish company has an exciting year ahead, and Chaplin is absolutely sure that the RSV vaccine is Bavarian's most important asset.

"It's clearly the one thing I'm most proud of. The fact that a Danish company is the world leader in RSV vaccination is a milestone in itself. Bavarian's vaccine stands out and is completely different from everyone else's, so I can't wait to initiate phase III next year," he says.

English Edit: Ida Løjmand

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