Celltrion and Rani Therapeutics to Jointly Develop Oral Formulation of Adalimumab Biosimilar

Celltrion and US-based Rani Therapeutics (“Rani”) announced that they entered an agreement to develop RT-105, an orally administered adalimumab biosimilar made using the RANIPILL platform.  The announcement explains that RANIPILL capsules are Rani’s payload agnostic oral delivery technology intended to replace subcutaneous or intravenous injection of biologics or drugs, and states that the RT-105 project is “the first announced partnership for a program involving the RANIPILL HC, a high-capacity device that is designed to deliver up to 20mg of payload with high bioavailability and is in preclinical testing.”  Pursuant to the agreement, Celltrion will exclusively supply the adalimumub biosimilar drug substance (CT-P17) for RT-105, Rani has an exclusive license to use CT-P17 to develop and commercialize RT-105, and Celltrion has “a right of first negotiation to acquire worldwide rights to RT-105 after a Phase 1 study.”

The RT-105 agreement expands upon an existing agreement between Celltrion and Rani for the joint development of an oral formulation of Celltrion’s CT-P43 biosimilar of STELARA (ustekinumab), upon which we previously reported.