Istodax, Gloucester’s only drug candidate, is also being evaluated in PTCL, multiple myeloma, and solid tumors.
Celgene is taking over Gloucester Pharmaceuticals for $340 million in cash to pad its position in the development of therapies for rare and debilitating blood cancers. Celgene will pay another $300 million if certain U.S. and international regulatory milestones are met.
Celgene’s decision follows on the heels of Gloucester winning FDA approval for Istodax in cutaneous T-cell lymphoma (CTCL). The drug, a histone deacetylase (HDAC) inhibitor, was sanctioned in November to treat patients who have received at least one prior systemic therapy.
Istodax is Gloucester’s only candidate in clinical development. It has orphan drug designation from the FDA and EMEA for the treatment of non-Hodgkin T-cell lymphomas, which includes CTCL and peripheral T-cell lymphoma (PTCL), as well as fast track status in PTCL.
Accrual of the Istodax registration trial for PTCL is expected to be completed early next year. Combination regimens of Istodax are also being investigated in hematologic and solid tumors at the Phase I and II stage.
Celgene’s portfolio of marketed drugs for blood disorders includes Revlimid for multiple myeloma (MM) and myelodysplastic syndromes (MDS), Vidaza for MDS, and Thalomid for MM and erythema nodosum leprosum.
Celgene expects to complete the transaction in the first quarter of 2010 and believes it will be neutral to non-GAAP diluted earnings for 2010 and accretive in 2011.