Janssen and Capricor reach licensing deal for cell therapy program

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Janssen Inks Up to $337.5M Cell Therapy Collaboration with Capricor
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' k9 O0 R' Q7 w6 g' G, G0 i1 cJohnson & Johnson’s Janssen Biotech entered into an exclusive license option agreement to develop Capricor Therapeutics’ cell therapy program for cardiovascular applications—including its lead product, CAP-1002, a heart-disease treatment now heading into Phase II clinical trials—in a deal that could net Capricor as much as $337.5 million./ _3 m: K! ?. Y5 @+ i

; j# a6 Z+ T, S; ]( s1 q& @Janssen agreed to pay Capricor $12.5 million up front, and up to $325 million if Janssen exercises option rights, plus royalties on commercial sales of CAP-1002. Under the agreement, Janssen has the right to enter into an exclusive license agreement for CAP-1002 at any time until 60 days after Capricor delivers six-month follow-up results from Phase II of its ALLSTAR clinical trial for the cell therapy.
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CAP-1002 is an allogeneic cardiosphere-derived cell therapy under study in patients who have suffered a large myocardial infarction.
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/ |. ?, c6 A7 l2 M. f# h& Y' C"This collaboration with Janssen, one of the world's largest and most respected healthcare companies with a strong presence in cardiovascular and metabolism, is a tremendous milestone for Capricor Therapeutics and an important validation of our lead product, CAP-1002, and the underlying science,” Capricor CEO Linda Marban, Ph.D., said in a statement.4 U+ X7 H1 i# e5 D4 Q. h9 ]# v0 U
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Capricor has won about $19.8 million in funding from California’s stem-cell agency, the California Institute for Regenerative Medicine (CIRM), toward the Phase II trial, through CIRM’s Disease Team Therapy Development-Research program. The trial will be designed to assess both safety and efficacy of a heart-derived stem cell product in patients who have experienced a heart attack either recently or in the past.
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Capricor told CIRM its Phase I data suggest that treatment with the heart-derived cell product under development can turn scar tissue back into healthy heart muscle. The clinical program for CAP-1002 also builds upon earlier research for which Eduardo Marbán, M.D., Ph.D., director of the Cedars-Sinai Heart Institute, won an earlier $5.56 million Disease Team Research I grant from CIRM.7 G# {# J6 a' N  W% }6 K) v, Z

8 `) s& ]0 o. _“The planned mid-stage trial will hopefully confirm that finding in a larger patient group and provide additional data to support the safety profile of the product,” the company stated in an abstract of the research published on CIRM’s website.( B5 o$ _, o  k/ f. V
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A successful Phase II trial would be followed by a Phase III study, then a marketing application to the FDA, Capricor added: “The end result could be an affordable stem cell therapy effective as part of a treatment regimen after a heart attack.”# @( X! N& V) {, h! j" H
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Capricor became publicly traded in July following its merger with Nile Therapeutics, under which Capricor became a wholly owned subsidiary of Nile.
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