Celltrion signs up to support Rani's oral biosimilar copy of J&J's Stelara, lands right of first negotiation

Rani Therapeutics has secured a supply of ustekinumab for an oral drug delivery program, partnering with Celltrion to access materials for its development of a biosimilar rival to Johnson & Johnson’s Stelara. The deal gives Celltrion the right of first negotiation on the oral ustekinumab biosimilar program.

Most doses of Stelara are delivered via subcutaneous injection, although adults with Crohn’s disease and ulcerative colitis receive their first dose as an intravenous infusion. Patients prescribed the drug lack an oral option. Last year, Rani outlined plans to change that by applying its RaniPill delivery technology to the monoclonal antibody. 

Now, Rani has sourced the monoclonal antibody for the candidate—and found a potential buyer for the program in the process. Celltrion is exclusively supplying Rani with ustekinumab for the program as part of a deal that gives it right of first negotiation for global rights to the oral candidate after a phase 1 trial. The ustekinumab biosimilar, CT-P43, is in phase 3 development as an injectable at Celltrion.

The Rani drug candidate, RT-111, is underpinned by a capsule designed to protect its therapeutic payload through the harsh environment in the stomach and get to the intestine. Upon reaching its destination, the capsule injects the drug into the intestinal wall. Rani is applying the technology to diseases including acromegaly and osteoporosis.  

Through the deal with Celltrion, a company that sees potential for the RaniPill platform to be applicable to other biologics, Rani has landed a partner to support its ambitions, as CEO Talat Imran explained in a statement. 

“This agreement is a validation of our RaniPill oral drug delivery technology, which has already performed well in two separate phase 1 trials of RT-101 and RT-102, respectively. We value Celltrion as the exclusive provider of ustekinumab biosimilar for our RT-111 program and look forward to sharing the results of our study in due course, and potentially broadening our partnership with Celltrion,” Imran said.