Citius Pharmaceuticals’ spinoff plans advance

Citius Pharmaceuticals Inc., a biopharmaceutical company headquartered in Cranford, announced March 30 that it’s moving forward with previously announced plans to spin off its oncology asset, I/ONTAK, into a separate publicly traded company. 

The company made the original spinoff announcement in May 2022, soon after it realigned its management team. At the time, Citius said the move would allow it to better focus on the commercial launch of its two late-stage products.

Maxim Group LLC will serve as financial advisor to its wholly owned subsidiary, Citius Acquisition Corp. Inc., in connection with the intended spinoff. The company added that the U.S. Food and Drug Administration (FDA) is reviewing a biologics license application (BLA) for I/ONTAK (denileukin diftitox), with a set targeted decision date of July 28. 

In December 2022, Citius said the FDA accepted its BLA for I/ONTAK, which is an engineered IL-2-diphtheria toxin fusion protein intended to treat patients with persistent or recurrent cutaneous T-cell lymphoma (CTCL). At that time, the targeted decision date was Sept. 28, 2023.

“Citius is committed to maximizing the value of I/ONTAK and advancing our pipeline. Maxim Group has a strong track record of executing strategic and financial transactions in the life science sector, and we look forward to working closely with them to optimize the structure and timing of contemplated I/ONTAK transactions,” Citius Chairman and CEO Leonard Mazur said in a statement. 

A previous version of the treatment, ONTAK, was marketed in the U.S. from 1999 to 2014, when it was voluntarily withdrawn from the market. However, advances in manufacturing led to the current formulation, which received regulatory approval in Japan in 2021 for the treatment of CTCL and peripheral T-cell lymphoma (PTCL). 

In 2011 and 2013, the FDA granted orphan drug designation to I/ONTAK for the treatment of PTCL and CTCL, respectively.