HELLERUP, Denmark—UNION Therapeutics A/S has announced the completion of an agreement with TFF Pharmaceuticals, Inc. to acquire an option for a worldwide exclusive license for the use of in combination with niclosamide, to be used as a treatment for COVID-19.

 

Under the agreement, UNION will acquire an option to obtain a worldwide exclusive license to TFF’s Thin Film Freezing technology, and rights relating to the formulations of niclosamide for the treatment of COVID-19. UNION will pay TFF up to US $210 million related to option exercise, development and commercial milestones, as well as tiered single-digit royalties on product sales.

 

“We have interacted closely with TFF and have been impressed with their team as well as their formulation technologies, which complement our current niclosamide-programs,” commented Prof. Morten Sommer, co-founder and CSO of UNION.

 

TFF’s Thin Film Freezing platform was designed to improve the solubility and absorption of poorly water-soluble drugs. It’s particularly suited to generate dry powder particles with properties targeted for inhalation delivery — especially to the deep lung, an area of significant interest in respiratory medicine.

 

Niclosamide was recently identified by Institut Pasteur Korea as a potent inhibitor of SARS-CoV-2, the virus which causes COVID-19, based on in vitro studies. Niclosamide reportedly has the potential to become a truly differentiated treatment of COVID-19, blocking replication of SARS-CoV-2 by targeting host cells to disrupt the viral life cycle.

 

UNION is progressing the niclosamide-based UNI911 through clinic development, and the agreement with TFF has the potential to substantially broaden UNION’s niclosamide product offering. The company is currently conducting a Phase 1 clinical trial of an optimized salt form of the compound, which was developed as a potential inhalation treatment for COVID-19.

 

Based on research from the University of Texas and the company’s patented formulation technology and expertise, TFF has developed alternative oral and inhalation versions of niclosamide, which are currently being prepared for human studies.

 

“Like UNION, TFF has been working with niclosamide for an extended period of time and has taken an interesting approach to the formulation of niclosamide for COVID-19. We are excited to formalize our collaboration with the TFF team and consolidate our joint efforts under the wings of UNION,” added Rasmus Toft-Kehler, CEO and co-founder of UNION. “This will allow us to maximize the likelihood of getting the best possible product to as many COVID-19 patient segments in the shortest possible timeframe.”