MedWatch

Former Leo Pharma candidate heads into big study as FDA fast-tracks assessment

Union Therapeutics is preparing a large-scale phase IIb trial to test its candidate orismilast within atopic dermatitis. On Thursday, the FDA fast-tracked the drug, potentially saving the biotech company "several months" in a potential approval case processing, the company's CFO says.

Morten Boesen, CFO at Union Therapeutics. | Photo: Union Therapeutics

Acquiring drug candidate orismilast from Leo Pharma in summer of last year in a deal valued up to DKK 1.2bn (USD 186.4m) has turned out to be a good decision for Union Therapeutics.

Last month, the company entered into a strategic collaboration and license agreement about orismilast with the Chinese company Innovent Biologics, which could end up paying Union Therapeutics up to USD 267m for the exclusive rights to the research, development and commercialization of the drug in China, Hong Kong, Macau and Taiwan. It was also recently revealed that the US Food and Drug Administration has fast-tracked the former Leo Pharma eczema candidate, which is an oral treatment for atopic dermatitis, commonly known as eczema.

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