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Citius Pharmaceuticals Acquires Dr. Reddy's Laboratories' License for Late-Phase 3 Oncology Immunotherapy (E7777) for the Treatment of Cutaneous T-Cell Lymphoma and other Cancer Indications
Citius expands late-stage pipeline with the acquisition of Dr. Reddy's exclusive license rights to E7777, an improved formulation of previously FDA-approved
About this update from Citius Pharmaceuticals, Inc.
[{"type":"text","content":"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.\n 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\n 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\n Citius plans to explore the potential of E7777 to treat larger patient populations with additional indications in PTCL and immuno-oncology\n\n\nCRANFORD, N.J., Sept. 7, 2021 /PRNewswire/ -- Citius Pharmaceuticals, Inc. (\"Citius\" or the \"Company\") (Nasdaq: CTXR) today announced that it has entered into a definitive agreement with Dr. Reddy's Laboratories SA, a subsidiary of Dr. Reddy's Laboratories, Ltd. (collectively, \"Dr. Reddy's\") (NYSE: RDY) to acquire its exclusive license of E7777 (denileukin diftitox), a late-stage oncology immunotherapy for the treatment of CTCL, a rare form of non-Hodgkin lymphoma. E7777, an engineered IL-2-diphtheria toxin fusion protein, is an improved formulation of oncology agent, ONTAK®, which was previously approved by the U.S. Food and Drug Administration (FDA) for the treatment of patients with persistent or recurrent CTCL. The last patient in a Pivotal trial of E7777 has been enrolled, and a biologics license application (BLA) for E7777's first indication in CTCL is expected to be filed with the FDA by the end of 2022. \nUnder the terms of this agreement, Citius will acquire Dr. Reddy's exclusive license of E7777 from Eisai Co., Ltd. (\"Eisai\") and other related assets owned by Dr. Reddy's. Citius's exclusive license rights include rights to develop and commercialize E7777 in all markets except for Japan and certain parts of Asia. Additionally, Citius will retain an option on the right to develop and market the product in India. Eisai retains exclusive development and marketing rights for the agent in Japan and Asia. Dr. Reddy's will receive a $40 million upfront payment ...