标题: Janssen and Capricor reach licensing deal for cell therapy program [打印本页] 作者: jack1381818 时间: 2014-1-9 09:26 标题: Janssen and Capricor reach licensing deal for cell therapy program
Janssen Inks Up to $337.5M Cell Therapy Collaboration with Capricor; N& ], L( Q6 r5 A+ ]# z8 e' m
& g! U5 e* s4 ^0 _Johnson & 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.+ h+ c+ Y2 o: c9 _9 P
' a- G5 n; d; B# a: E1 ]* r% qJanssen agreed to pay Capricor $12.5 million up front, and up to $325 million if Janssen exercises option rights, plus royalties on commercial sales of CAP-1002. Under the agreement, Janssen has the right to enter into an exclusive license agreement for CAP-1002 at any time until 60 days after Capricor delivers six-month follow-up results from Phase II of its ALLSTAR clinical trial for the cell therapy. ; a/ r) t% @7 V) X' y' E5 @3 ^5 ? q( g# S5 w" Z
CAP-1002 is an allogeneic cardiosphere-derived cell therapy under study in patients who have suffered a large myocardial infarction. 4 v4 _3 X$ b) S4 z8 V p2 J9 I" b4 [4 V, R& X+ u0 \* k
"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.0 N# `/ e% N1 J$ l6 \* ? Z6 }
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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. 4 i0 S K/ e) g) J& S& R6 \ V" a6 c2 [& a2 i# ?, J+ i; n
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 $5.56 million Disease Team Research I grant from CIRM. * y c7 Q9 i" N# D$ R6 h: }; t5 S8 `% d
“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. 5 Q- d8 M% p: g+ }) R2 b 2 y0 c& Z9 y) j$ ~+ {! JA 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.”0 k5 K( V6 U* V/ O, Y4 s
3 |( {7 e) o# s7 wCapricor became publicly traded in July following its merger with Nile Therapeutics, under which Capricor became a wholly owned subsidiary of Nile. " t+ Q4 F% L2 I5 {1 M " y4 d: S0 x# T* A, V