Press Release

TFF Pharmaceuticals Enters into Worldwide Licensing Agreement with UNION therapeutics for its Thin Film Freezing Technology in Combination with niclosamide

August 13, 2020 at 4:00 PM EDT

Aims to accelerate development and commercialization of dry powder forms of niclosamide as a new potential treatment for COVID-19

Agreement provides for UNION therapeutics’ potential payment of development, regulatory and sales-related milestone payments of up to $210 million as well as tiered royalties

AUSTIN, Texas--(BUSINESS WIRE)--Aug. 13, 2020-- TFF Pharmaceuticals, Inc. (NASDAQ: TFFP), a clinical-stage biopharmaceutical company focused on developing and commercializing innovative drug products based on its patented Thin Film Freezing (TFF) technology platform, today announced that it has entered into a worldwide exclusive licensing agreement with UNION therapeutics A/S (UNION) 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, UNION 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 (contracts, grants, etc.) with the aim of funding the development of niclosamide-based products for the treatment of COVID-19.

Niclosamide is an oral anthelminthic drug, first approved by the US FDA for use in humans in 1982 and is included in the World Health Organization's list of essential medicines1. 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.2 Niclosamide has been shown to exhibit potent antiviral activity against SARS-CoV-23 and totally eliminated viral antigen synthesis at a concentration of 1.56 μM.4 However, niclosamide has limited aqueous solubility as well as low absorption and oral bioavailability5 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.”

“We’ve made significant progress in the past three months in our efforts to examine niclosamide for potential COVID-19 applications,” continued Mattes. “This agreement will further those efforts as well as provide a number of opportunities to synergize both our company’s drug portfolios in new, potentially more effective combinations for eventual commercialization.”

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.”

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 multiple candidates in clinical development. The leadership team of UNION has successfully developed multiple approved drugs on the market. UNION is headquartered in Copenhagen (Denmark) and managed by an experienced team across Europe and USA.

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 42 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 Korea6, 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.

References:

  1. WHO. World Health Organization; Geneva: 2007. The Selection and Use of Essential Medicines.
  2. Broad Spectrum Antiviral Agent Niclosamide and Its Therapeutic Potential, Jimin Xu, Pei-Yong Shi, Hongmin Li, and Jia Zhou ACS Infectious Diseases Article ASAP
    DOI: 10.1021/acsinfecdis.0c00052
  3. Identification of antiviral drug candidates against SARS-CoV-2 from FDA-approved drugs
    Sangeun Jeon, Meehyun Ko, Jihye Lee, Inhee Choi, Soo Young Byun, Soonju Park, David Shum, Seungtaek Kim
    DOI: 10.1128/AAC.00819-20
  4. Alhalaweh, A., Alzghoul, A., Kaialy, W., Mahlin, D. & Bergström, C. A. S. Mol. Pharm. 11, 3123–3132 (2014). Barbosa, E. J., Löbenberg, R., de Araujo, G. L. B. & Bou-Chacra, N. A. Eur. J. Pharm. Biopharm. 141, 58–69 (2019).
  5. Wu, C.-J., Jan, J.-T., Chen, C.-M., Hsieh, H.-P., Hwang, D.-R., Liu, H.-W., Liu, C.-Y., Huang, H.-W., Chen, S.-C., Hong, C.-F., Lin, R.-K., Chao, Y.-S., and Hsu, J. T. A. (2004) Inhibition of severe acute respiratory syndrome coronavirus replication by niclosamide. Antimicrob. Agents Chemother. 48, 2693– 2696, DOI: 10.1128/AAC.48.7.2693-2696.2004
  6. Identification of antiviral drug candidates against SARS-CoV-2 from FDA-approved drugs Sangeun Jeon, Meehyun Ko, Jihye Lee, Inhee Choi, Soo Young Byun, Soonju Park, David Shum, Seungtaek Kim DOI: 10.1128/AAC.00819-20

SAFE HARBOR

This press release contains forward-looking statements regarding TFF Pharmaceuticals, Inc., including the license agreement with UNION therapeutics, the potential success of the collaboration between TFF and UNION, TFF’s potential receipt of milestone and sales-based payments from UNION, the benefits of the Company’s TFF platform and its dry powder formulations of niclosamide and other materials, and the Company’s plans to add to its existing pipeline of product candidates and license its technology to third-parties. Those forward-looking statements involve known and unknown risks, uncertainties and other factors that could cause actual results to differ materially. Among those factors are: (i) the risk that UNION will not exercise its option and that the collaboration will go no further than the investigator lead studies, (ii) if UNION does exercise its option to license TFF’s technologies, the risk that UNION will not pursue the development of a product candidate under the license with TFF or, if it does, that such product candidate will obtain regulatory approval or commercial success, (iii) the risk that few, or none, of the milestone or sales and sales-based payment will be satisfied and TFF will receive little, or none, of such milestone and sales-based payments, (iv) the fact that no drug product incorporating the TFF platform has received FDA pre-market approval or otherwise been incorporated into a commercial drug product, and (v) the Company has no current agreements or understandings with any large pharmaceutical companies for the development of a drug product incorporating the TFF Platform, and (v) those other risks disclosed in the section “Risk Factors” included in the Company’s 2019 Annual Report on Form 10-K filed with the SEC on March 26, 2020. TFF Pharmaceuticals cautions readers not to place undue reliance on any forward-looking statements. TFF Pharmaceuticals does not undertake, and specifically disclaims, any obligation to update or revise such statements to reflect new circumstances or unanticipated events as they occur, except as required by law.

TFF Pharmaceuticals:

Glenn Mattes
President and CEO
TFF Pharmaceuticals, Inc.
gmattes@tffpharma.com
737-802-1973

Kirk Coleman
Chief Financial Officer
TFF Pharmaceuticals, Inc.
kcoleman@tffpharma.com
817-989-6358

Investor Relations and Media Contact:
Paul Sagan
LaVoieHealthScience
psagan@lavoiehealthscience.com
617-953-4779

UNION Therapeutics

Morten Boesen
Chief Financial Officer
Tel: +45 2381 5487
Email: info@uniontherapeutics.com

Source: TFF Pharmaceuticals, Inc.

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