A pair of Celgene partners gets on the FDA fast track

Celgene's ($CELG) expansive approach to partnering continues to bear fruit, as two of the Big Biotech's in-licensed treatments have been added to the FDA's fast-track program, promising a speedy regulatory review as each approaches Phase III.

Acceleron Pharma ($XLRN) picked up the fast-track nod for luspatercept, a protein therapy designed to treat the rare blood disorder beta-thalassemia, which can lead to iron overload and organ failure. The drug is now in the midst of a Phase II trial with a late-stage effort planned for this year. Under a 2011 deal, Celgene paid $25 million up front and promised $217 million to partner up on luspatercept, committing to handle the drug's Phase III development. Bluebird bio ($BLUE), another Celgene collaborator, is at work on a high-profile gene therapy for the same disease.

Separately, Celgene partner Agios Pharmaceuticals ($AGIO) got its AG-120 into the fast-track program, advancing a treatment now in Phase I for acute myelogenous leukemia (AML), an aggressive form of marrow cancer. Agios is expecting to present Phase I data on the drug next month, and, with Celgene's help, kick off a Phase III program in the first half of next year. Like most of Agios' projects, AG-120 targets cellular metabolism to essentially starve cancers to death, and Celgene, after opting in on the drug earlier this year, is promising up to $120 million for a share of its future revenue.

The fast-track program is designed to expedite the development of treatments for under-served diseases--like beta-thalassemia and AML--and grants drugmakers access to top agency officials as they work through the regulatory process. And, if fast-tracked projects meet certain agency criteria, the FDA allows for rolling submissions and shortens its review time from 10 months to 6 months.

The regulatory nods cap a busy dealmaking season for Celgene, which has signed more than $1 billion worth of partnerships and buyouts over the last 30 days, illustrating its commitment to expanding its pipeline by any means available.

- read the Agios news
- here's the Acceleron release

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