Big Pharma's J&J Buys Into California Stem Cell Therapy Research for Heart Disease

California's $27 million investment involving a Beverly Hills stem cell firm is paying off once again as the business attracted a major, financial vote of confidence from Big Pharma's Johnson&Johnson.

The firm, Capricor Therapeutics, last month received approval for a phase two clinical trial for its heart disease therapy. Yesterday, it announced that the Janssen Biotech arm of Johnson&Johnson was immediately pumping $12.5 million into the product with the potential of $325 million more, depending on the outcome of the phase two trial.

Linda Marban
Capricor photo

John Carroll of Fierce Biotech wrote that the move marked a “rare Big Pharma gamble on a field that is trying hard to mount a comeback.” The California stem cell agency, which is funding the phase two trial, said the news was “heartening”and a represented a “very good start” to the year for Capricor.

Linda Marban, CEO of Capricor, told Fierce Biotech that J&J had been probing Capricor for a year. She said, 

“One of the reasons why I was motivated to work on this deal is because of the statement it makes in the field. It says, OK, somebody very large and powerful is taking a look at this technology and saying there's something there, and that's the most exciting thing for me."

Interest from the “large and powerful” is of major importance not only to Capricor but to the stem cell agency, which runs out of state money for new research grants in 2017. It is slowly trying to develop other sources of revenue, and it has yet to bring a therapy to market despite promises to voters during the 2004 ballot campaign that created the agency. Votes of confidence from Big Pharma will go a long way in encouraging investment in the agency and the stem cell field generally.

Investors indeed were more than encouraged by the yesterday's news, which sent Capricor's stock soaring 48 percent. It closed at $5.06 yesterday, up from $3.40 on Friday. Marban has said the firm hopes to be profitable by 2018.

Johnson&Johnson's investment is not the first tied to a key executive at Capricor, Frank Litvack, who is executive chairman of the firm. Litvack, who unsuccessfully ran in 2011 against Jonathan Thomas for the chairmanship of the stem cell agency, sold Conor MedSystems to J&J for $1.6 billion in 2006.

Bradley Fikes of the San Diego U-T discussed the Capricor research late last month in some detail. One of the phase one trial sites was at Scripps Health. Fikes wrote,

“Mark Athens received Capricor’s treatment on Sept. 25, about a month after having a moderate heart attack. The Encinitas resident was the last treated under Phase 1, said Scripps cardiologist Richard Schatz, who performed the procedure. It will take about six months to know whether the treatment worked, Schatz said.”

Fikes continued,

“'All their previous work showed that the scar got smaller and the muscle tissue around it got more robust,' Schatz said. 'So two things happened: The viable tissue got bigger and the scar got smaller. And that should translate into some sort of clinical benefit down the road.'”

Here are links to the press release from Capricor and other stories in story Genetic Engineering and Biotechnology News and PharmaTimes.

Cardiologist/Entrepreneur Eyed for Stem Cell Agency Chair

Frank Litvack
Cedars Photo

A Los Angeles cardiologist who is also described as a "serial entrepreneuer" is under consideration as a possible candidate for chairman of the $3 billion California stem cell agency.

He is Frank Litvack, former CEO of of Conor Medsystems Inc. of Menlo Park, Inc., which was purchased by Johnson & Johnson for $1.4 billion in 2006. Conor developed what Business Week called a "new breed of stent."

Several sources told the California Stem Cell Report that Litvack is one of several possibilities to replace Robert Klein, who is resigning effective June 23, as chairman of CIRM.

Four statewide officials are scheduled to make nominations for the post on Monday. At one point earlier this year, it appeared that there would be an effort to have the four nominate one person. However, that attempt has fallen by the way. John M. Simpson, stem cell project director at Consumer Watchdog of Santa Monica, Ca., said,

"There will definitely be choices."

The 29-member CIRM board is expected to vote on the candidates at its meeting June 23 in San Diego. The CIRM directors Evaluation Subcommittee is expected to schedule a closed door meeting to interview candidates, who will make public presentations to the full board probably at the June meeting. At that time, the public will have an opportunity to comment.

The California Stem Cell Report disclosed yesterday that Jonathan Thomas, chairman of the Saybrook Capital of Santa Monica, Ca., is also under consideration as a candidate. Thomas is reportedly backed by Klein, although Klein has denied that via a spokesman.

Thomas is believed to support the current dual-executive structure at CIRM with overlapping responsibilities involving the chair and the president. The structure has been strongly criticized and has created public conflict in the past. Litvack reportedly favors a role that would place the chair instead in more of an oversight role.

Litvack has a slight connection already to the CIRM board. He and Sherry Lansing, chair of the CIRM Governance Committee, both serve on the Health Board of Advisors at RAND, a Santa Monica, Ca., thinktank.

In 2005 while Litvack was head of Conor, Business Week wrote about how the firm provided stock options to some doctors evaluating its technology, which was well-regarded.

The magazine said,

"Yet Conor's technology is difficult to assess, in part because some doctors helping to evaluate the devices have received stock options from the company. Among the 14 doctors who sit on Conor's scientific advisory board and are participating in clinical trials of its stent, three received consulting fees and five have received options, according to documents obtained by BusinessWeek.

"Such relationships are a growing source of concern in the medical-device industry, drawing increasing scrutiny from regulators and medical ethicists. Still, Wall Street is smitten with Conor's potential."

According to Bloomberg Business Week, Litvack is managing director of Calmedica Capital LP and a director of Nile Therapeutics Inc. and Pervasis Therapeutics Inc. From 1986 to 2000, he co-directed the Cardiovascular Intervention Center at Cedars-Sinai Medical Center. He has also founded Progressive Angioplasty Systems Inc., and co-founded itherX Pharmaceuticals, Inc.