Janssen and Capricor reach licensing deal for cell therapy program

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Janssen Inks Up to $337.5M Cell Therapy Collaboration with Capricor
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$ B9 l& m1 _' s6 ]1 F: x$ AJohnson & 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.. `+ B+ Y/ u1 Z( E8 L

6 {2 ], \  j( ?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.6 ^8 n0 D! ^( y
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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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& \+ B! D2 S3 M4 O6 a- h. ^. {3 u"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.8 n! \  U1 G- X  I( D" H3 A

2 g9 v+ b8 N" L! }( a# b1 S) RCapricor 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." n& \; x* t9 t& ^0 ^) C9 J4 E

% S+ K; p& H1 D0 q“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.& n0 Z' |, U5 @5 j
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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.”- c4 d7 ]( m/ ?. u% Z
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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.  j' a! ?' y! d9 E, H3 t$ B

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