TFF Pharmaceuticals Inc., a clinical-stage biopharmaceutical company focused on developing and commercializing innovative drug products based on its patented Thin Film Freezing (TFF) technology platform, has entered into a worldwide exclusive licensing agreement with Union Therapeutics A/S for its TFF technology used in combination with niclosamide.
 
Under the terms of the agreement, Union will acquire an option to obtain a worldwide exclusive license of TFF Pharmaceuticals to its TFF technology to be used in the field of niclosamide, including oral and inhalation versions of niclosamide, potentially for COVID-19, as well as other niclosamide-based therapies. Subject to Union’s exercise of its option, it has agreed to pay TFF Pharmaceuticals potential development, regulatory and sales-related milestone payments of up to $210 million. Union will also pay TFF tiered single-digit royalties on product sales. TFF Pharmaceuticals and Union have agreed to collaborate on securing government support with the aim of funding the development of niclosamide-based products for the treatment of COVID-19.
 
What is Niclosamide?
 
Niclosamide is an oral anthelminthic drug, first approved by the FDA for use in humans in 1982. It has been used to safely treat millions of patients. More recently, niclosamide has been identified as a multifunctional drug, via drug repurposing screens, with potential to be repurposed to treat a variety of viral infections such as severe acute respiratory syndrome coronavirus (SARS-CoV), Middle East respiratory syndrome coronavirus (MERS-CoV), Zika virus (ZIKV), and others, given its inexpensive cost and low in-vivo toxicity profile as an FDA-approved drug in clinical use. Niclosamide has been shown to exhibit potent antiviral activity against SARS-CoV-23, however it has limited aqueous solubility as well as low absorption and oral bioavailability creating challenges for its development as a potential anti-viral therapy. TFF Pharmaceuticals’ TFF technology has demonstrated improvements to the solubility of oral forms of niclosamide as well as to dry powder forms of the drug for delivery directly to the lungs.
 
“We are very excited to be entering into this agreement with Union therapeutics, a company that has had an extensive history working with niclosamide and the compound class in a number of therapeutic areas,” said Glenn Mattes, president and CEO of TFF Pharmaceuticals. “We believe this agreement will help speed up efforts to investigate the promising use of niclosamide for potential COVID-19 therapies using our breakthrough TFF technology to provide a viable therapeutic option with a new delivery method.”
 
Union has worked with niclosamide and the related chemical class for over six years and is currently conducting a Phase 2b study with niclosamide in atopic dermatitis patients. The company has built extensive knowledge and intellectual property rights around the compound class, formulations and various methods of delivery as well as broadening the pipeline to cover additional diseases within inflammation and infection.
 
“Our hope is for the consolidated efforts under the agreement to enable Union to leverage our extensive knowledge of niclosamide and further accelerate the development of treatment options to a broader range of COVID-19 patients,” said professor and CSO and co-founder of Union, Morten Sommer. “We look forward to working with the team at TFF Pharmaceuticals to leverage the TFF technology platform in bringing new treatment options to COVID-19 patients.”