Citius expands late-stage pipeline with the acquisition of Dr. Reddy's exclusive license rights to E7777, an improved formulation of previously FDA-approved ONTAK®; the exclusive license is with Eisai Co. Ltd.
Patient enrollment has been completed in the Pivotal Phase 3 trial for the treatment of relapsed or refractory cutaneous T-cell lymphoma (CTCL) with a BLA filing expected by the end of 2022; if approved, the BLA will provide regulatory exclusivity for 12 years; E7777 has been granted orphan drug designation by the FDA for the treatment of CTCL
Citius's exclusive license of E7777 is for all markets excluding certain parts of Asia and Japan; E7777 was approved in Japan for the treatment of CTCL and PTCL in 2021
Citius plans to explore the potential of E7777 to treat larger patient populations with additional indications in PTCL and immuno-oncology
PR Newswire
CRANFORD, N.J., Sept. 7, 2021
