Celltrion said on Monday that it signed a contract with U.S.-based Rani Therapeutics to jointly develop an oral formulation of its Stelara biosimilar CT-P43 (ingredient: ustekinumab) for the treatment of psoriasis, Crohn's disease, and ulcerative colitis.

Celltrion said on Monday that it signed a contract with U.S.-based Rani Therapeutics, to jointly develop an oral formulation of its Stelara biosimilar CT-P43 (ingredient: ustekinumab) for the treatment of psoriasis, Crohn's disease, and ulcerative colitis.
Celltrion said on Monday that it signed a contract with U.S.-based Rani Therapeutics, to jointly develop an oral formulation of its Stelara biosimilar CT-P43 (ingredient: ustekinumab) for the treatment of psoriasis, Crohn's disease, and ulcerative colitis.

Accordingly, Celltrion will exclusively supply its CT-P43 biosimilar to Rani Therapeutics for the non-clinical and phase 1 clinical trials of oral ustekinumab (development name: RT-111), with preferential negotiating rights for future global development and marketing rights.

CT-P43's original drug Stelara, an inhibitor of interleukin (IL)-12 and 23, is available in two formulations -- intravenous and subcutaneous injection. According to Johnson & Johnson, Stelara is a blockbuster biopharmaceutical with sales of $9.13 billion in 2021.

Rani Therapeutics has developed a platform technology that enables oral use of intravenous and subcutaneous injection formulations of protein and antibody drugs through its proprietary oral capsule platform, RaniPill. With this technology, capsules are broken down in the small intestine, and drugs are delivered to the small intestine through soluble microneedles in the capsule to move to blood vessels.

Celltrion plans to expand cooperation in applying innovative drug delivery platforms throughout its product pipeline, starting with the oral ustekinumab new drug development collaboration.

An official from Celltrion said, "By collaborating on the development of an oral treatment for ustekinumab, we expect to secure product competitiveness of CT-P43 and bring innovation and diversity to the future pipeline."

“We are excited to collaborate with Celltrion, a leader in biosimilars and biopharmaceuticals, on RT-111 and hope to expand the partnership between the two companies,” said Rani Therapeutics CEO Talat Imran.

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