UNION therapeutics A/S enters option agreement to acquire worldwide exclusive license for COVID-19 technologies developed by TFF Pharmaceuticals, Inc.

·         Niclosamide identified as a potent inhibitor of SARS-Cov-2 by Institut Pasteur Korea, with potency >40x higher than remdesivir

·         UNION has advanced niclosamide-based program for COVID-19 (UNI911) to clinical development, currently in Phase 1 study

·         TFF formulation technology can broaden the possible range of niclosamide formulations and treatments

·         Collaboration between UNION and TFF holds potential to make niclosamide treatments available to a broader range of patients globally

Hellerup, Denmark, August 13 2020 – UNION therapeutics A/S (“UNION”) today announced the completion of an agreement with TFF Pharmaceuticals, Inc. (“TFF”) to acquire an option to obtain a worldwide exclusive license for the use of their Thin Film Freezing technology in combination with niclosamide to focus on treatments for COVID-19.

Niclosamide was recently identified by Institut Pasteur Korea as a potent inhibitor of SARS-CoV-2, the virus causing COVID-19¹.

For a number of years, UNION has worked with niclosamide as a potential treatment for a range of inflammatory and infectious diseases. The Company is currently conducting a Phase 1 clinical trial of an optimized salt form of the compound developed as a potential inhalation treatment of COVID-19.

Based on research from the University of Texas and its patented formulation technology and expertise, TFF has developed alternative oral and inhalation versions of niclosamide, which are currently being prepared for human studies. Under the agreement, UNION will acquire an option to obtain a worldwide exclusive license to the technology and rights relating to the formulations of niclosamide for the treatment of COVID-19. UNION is already progressing the niclosamide-based product UNI911 through clinic development, and the agreement with TFF has the potential to substantially broaden UNION’s niclosamide product offering.

“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. 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,” said Rasmus Toft-Kehler, CEO and co-founder of UNION.

Prof. Morten Sommer, co-founder and CSO of UNION further commented; “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.”

Under the agreement, UNION will pay TFF up to 210 million USD related to option exercise, development and commercial milestones, as well as tiered single-digit royalties on product sales.

About UNION therapeutics A/S

UNION therapeutics A/S is a privately held, clinical stage, pharmaceutical company dedicated to the development of novel treatments for inflammatory and infectious diseases. The Company is working on two complementary chemistry classes spanning immunology and microbiology and has three candidates in clinical development. UNION is headquartered in Hellerup (Denmark) and managed by an experienced team across Europe and USA. For more information please visit www.uniontherapeutics.com.

About TFF Pharmaceuticals’ Thin Film Freezing technology platform

TFF Pharmaceuticals’ Thin Film Freezing (TFF) platform was designed to improve the solubility and absorption of poorly water-soluble drugs and is particularly suited to generate dry powder particles with properties targeted for inhalation delivery, especially to the deep lung, an area of extreme interest in respiratory medicine. The TFF process results in a “Brittle Matrix Particle,” which possesses low bulk density, high surface area, and typically an amorphous morphology. allowing the particles to supersaturate when contacting the target site, such as lung tissue. Based upon laboratory experiments the aerodynamic properties of the particles are such that the portion of a drug deposited to the deep lung has the potential to reach as high as 75 percent.

About TFF Pharmaceuticals

TFF Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company focused on developing and commercializing innovative drug products based on its patented Thin Film Freezing, or TFF, technology platform. Early testing confirms that the TFF platform can significantly improve the solubility and absorption of poorly water-soluble drugs, a class of drugs that comprises approximately one-third of the major pharmaceuticals worldwide, thereby improving their pharmacokinetics. TFF Pharmaceuticals has two lead drug candidates: Voriconazole Inhalation Powder and Tac-Lac Inhalation Powder. The Company plans to add to this pipeline by collaborating with large pharmaceutical partners. The TFF Platform is protected by 41 patents issued or pending in the US and internationally. To learn more about TFF Pharmaceuticals and its product candidates, visit the Company’s website at https://tffpharma.com.

About niclosamide in COVID-19

Recent studies undertaken by the Institut Pasteur Korea, an infectious disease-focused research institute, have identified niclosamide as one of the most potent inhibitors of SARS-Cov-2; the virus causing COVID-19 based on in vitro studies. Niclosamide has the potential to become a truly differentiated treatment of COVID-19, effectively blocking replication of SARS-CoV-2 by targeting host cells to disrupt the viral life cycle.