Janssen and Capricor reach licensing deal for cell therapy program

jack1381818

Janssen Inks Up to $337.5M Cell Therapy Collaboration with Capricor
0 n* i9 k7 H8 P% p* y4 s% j4 f4 P! p: @( _% R# s% S- U; F. P
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 $337.5 million.4 b! f' @: f9 X
, s9 D( s# `$ R
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.9 u3 O) ^7 B3 }* o: k4 _2 A

3 I4 M/ i* I4 v6 t& \0 }CAP-1002 is an allogeneic cardiosphere-derived cell therapy under study in patients who have suffered a large myocardial infarction.. T3 c6 V$ q" F8 m% _# A
* K( I: F4 W6 B  C0 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.
  g7 P: \& I8 y+ E. Y
7 ~/ Q/ i  q* p" X  JCapricor has won about $19.8 million in funding from California’s stem-cell agency, the California Institute for Regenerative Medicine (CIRM), toward the Phase II trial, through CIRM’s Disease Team Therapy Development-Research program. The trial will be designed to assess both safety and efficacy of a heart-derived stem cell product in patients who have experienced a heart attack either recently or in the past./ p. O' j, V" Q3 Q2 [
/ a$ D# q$ S  ]+ k3 c8 f+ T
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 $5.56 million Disease Team Research I grant from CIRM.9 o/ h$ E1 X9 \1 z
- R1 \+ ]* \/ N. Y, w9 t
“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.3 c( n% S& h; x4 \+ O3 @

6 ?* X; j% X. F& LA 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.”9 P- Q- s9 H! @  u- g/ |( g2 B
" k# I6 Q5 Z6 M& ~4 m6 g- ^
Capricor became publicly traded in July following its merger with Nile Therapeutics, under which Capricor became a wholly owned subsidiary of Nile.
3 ]# b1 K8 c) N3 `* s) ]5 p. I5 u! `; F* }. W