Janssen sign

Janssen agrees $780 million deal for authorisation of Cidara flu treatment

pharmafile | April 6, 2021 | News story | Manufacturing and Production Janssen, cidara, influenza 

Janssen has struck a deal worth up to $780 million with Cidara Therapeutics for exclusive worldwide rights to Cidara’s CD388 medicine for the treatment and prevention of influenza.

Under the collaboration, Cidara will remain responsible for the development and manufacturing of CD388, into the clinic and through Phase II clinical development; Janssen will then be in charge of late-stage development, manufacturing, registration, and global commercialisation. 

In return, Cidara will receive an upfront payment of $27 million, and Janssen will fund all future research, development, manufacturing and commercialisation for CD388. 

The therapeutics company will also receive up to $753 million in budgeted R&D funding, and development, regulatory, and commercial milestones, plus tiered royalties on worldwide sales of the drug. Cidara has the option to co-detail CD388 in the US.

CD388 is a long-acting antiviral immunotherapy designed to deliver universal protection for an entire influenza season. It targets a highly conserved region on the virus, meaning it has the potential to protect individuals from all strains, including seasonal and pandemic influenza A, influenza B, and major clinically characterised drug-resistant influenza strains. 

Cidara expects to file an Investigational New Drug Application for CD388 with the FDA by the end of this year.

An estimated 100 million people in the US are at high risk for complications due to seasonal influenza, with up to 650,000 deaths due to the virus worldwide each year. 

Jeffrey Stein PhD, President and CEO of Cidara, said: “This collaboration represents a significant advancement toward fulfilling our vision of providing universal, seasonal protection against all seasonal and pandemic strains of influenza.

”We believe Janssen, with its expertise in the development and commercialisation of vaccines, and therapies for viral respiratory diseases, is the ideal partner to rapidly advance CD388. Importantly, this agreement validates our Cloudbreak antiviral platform as we continue to advance our AVC programs in RSV, HIV and SARS-CoV-2.”

Jack Goddard

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