Janssen is sticking with a 2021 agreement for Cidara Therapeutics' flu prophylaxis, but the Big Pharma intends to offload rights to someone else amid a shutdown of infectious disease R&D.
Cidara said Janssen has elected to proceed with CD388, a formal notice that triggered a $7 million milestone payment to Cidara, according to an announcement Wednesday. However, the smaller biotech also said that Janssen does not intend to develop the asset but rather to “transfer its rights and obligations under the agreement to another entity,” according to a release.
Cidara had previously disclosed Janssen’s intentions to discontinue internal development amid a larger winding down of all infectious disease and vaccine R&D, as previously reported by Fierce Biotech. The company also said that once it submitted full phase 2 data to Janssen, the latter would have 90 days to decide whether it would proceed with the program. Cidara CEO Jeff Stein, Ph.D., said in an interview that Janssen considered CD388 "the marquee program in their infectious disease portfolio."
"They really share that vision with us and even though they're exiting the infectious disease space, they thought was very important that they do whatever they can to advance the program," he said.
The deal was first announced in April 2021 with Janssen taking on late-stage development and commercialization rights for CD388 in addition to other potential antiviral conjugates. Cidara was responsible for phase 1 and 2 development of CD388, with Janssen taking the reins from there. Janssen coughed up $27 million in upfront cash in addition to $753 million in R&D funding and milestone payments. Cidara said Wednesday that it still stands to gain $685 million in milestone payments plus any commercial royalties.
Arrowhead Pharmaceuticals has been in a similar spot as it awaits word from Janssen on next steps for a partnered hepatitis B med, ARO-HBV. Like Cidara, Janssen will have the opportunity to proceed with the deal but can offload the rights to a different company.
Cidara reported interim phase 2 data in March showing that patients receiving CD388 had a lower viral load and reduced the incidence of influenza infection. Full data is set to be presented at IDWeek next month, Stein says.
"We believe that working with an appropriate external partner is the best way to advance JNJ-0953 as a universal flu prevention option for at-risk populations, and therefore, we intend to transfer the rights and obligations to the program to another entity in the future, including all development, manufacturing and commercialization activities," according to a statement from Janssen. The company said it wouldn't comment on ongoing business development discussions.
Stein noted the new partner will likely be another Big Pharma and that potential suitors have reached out after the company publicly disclosed its divestments from the infectious disease space. He added that because the original deal was signed when CD388 was a preclinical asset, he expects there will be additional value Janssen could pursue in a new deal.
Editor's note: This story was updated with comments from Janssen and Cidara CEO Jeff Stein.