Bridgewater, NJ - Celgene's 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 $120 million for a share of its future revenue.
Separately, Celgene partner Agios Pharmaceuticals ($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.
