Friday, May 31, 2013

Bluebird bio of Massachusetts Still Waiting for California Stem Cell Money

Seven months after the California stem cell agency awarded $9.4 million to bluebird bio of Cambridge, Mass., the company has yet to receive any of the cash from the Golden State.

Kevin McCormack, a spokesman for the $3 billion agency, this week said negotiations are still underway with the bluebird, which is planning to go public,  but did not elaborate. Post-award negotiations are common at the agency, but generally take much less time.

The cash from CIRM is scheduled to assist in clinical trials for a stem cell-gene therapy to correct a genetic disease in young patients with B-thalassemia, a rare blood disorder that can cause widespread organ damage and premature death.

Earlier this month, bluebird bio, which prefers the lower case lettering for its name, announced that it intends to take the company public in an $86 million offering. In March, it announced a collaboration with Celgene that provided for an upfront payment of $75 million and promised up to $225 million per product in potential option fees and clinical and regulatory milestones. The CIRM grant is conditioned on a matching commitment from bluebird.

Cash from the stem cell agency can only be spent on operations within California. According to the CIRM summary of the review of the bluebird application, which was scored at 73, the company said,
“We will have at least two clinical sites in California, and more likely up to 4 sites, 2) our viral vector manufacturing will occur in California, 3) our cell processing will occur in California, 4) we will hire several consultants and full-time employees within California to support the program. Overall, several million dollars will be spent employing the services of people, academic institutions, and other companies within the state of California.”
The company has said that it is working with Donald Kohn at UCLA and Elliot Vichinsky at Oakland's Children's Hospital.

The bluebird web site lists a California location for bluebird at 1001 Bayhill Dr, Suite 200, in San Bruno, which is south of San Francisco. An Internet search indicates that is a generic address for a number of business including a realty firm, a roof repair business and a family law attorney. The California Stem Cell Report has asked bluebird to clarify the nature of the address.

In an interview last October with Ron Leuty of the San Francisco Business Times, David Davidson, the lead scientist on the project, said,
“We began the process (with CIRM) early in (2012) but discussions have been going on for over a year about potentially pursuing this.
“The interaction with CIRM has been extraordinarily collaborative. We had contact with the coordinators at CIRM that helped us manage the process. It took a lot of effort on our part to put together a dossier providing support for our program. It was really like a mini-regulatory filing — on the science, the preclinical toxicology work that we’ve done, a detailed plan for the trial, a detailed plan for the budgets, a detailed plan on how we intended to spend the CIRM money in California. That was an important part of it. They wanted a clear plan on how this investment would be spent."
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