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  • 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.

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

JW Communications
Julia Wilson
Tel: +44 781 8430877
Email: communications@uniontherapeutics.com

1 Source: https://www.biorxiv.org/content/10.1101/2020.03.20.999730v2.full.pdf

 

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  • Candidates in the LEO PDE4 inhibitor compound series have demonstrated potential to become ‘best-in-class’ based on Phase 2 studies in psoriasis (oral) and atopic dermatitis (topical)
  • PDE4 compound series strengthens UNION’s pipeline and offers potential synergies at organizational, financial and commercial levels

Hellerup, Denmark, July 21, 2020 – UNION therapeutics A/S (“UNION”) today announced the completion of a transaction with LEO Pharma A/S (LEO Pharma) to acquire the global rights for the LEO PDE4 inhibitor compound series to be re-named UNI500.

UNI500 is a series of phosphodiesterase type 4 (PDE4) inhibitors that were discovered by LEO Pharma. LEO Pharma has been developing candidates from this series from discovery into Phase 2 in psoriasis (orismilast, oral) and atopic dermatitis (orismilast, topical) and in both indications demonstrated superior effect over placebo in randomized, double-blinded, placebo-controlled clinical studies.

“The acquisition of the PDE4 inhibitor compound series is perfectly aligned with UNION’s vision to build a sustainable pharmaceutical company and it complements our current clinical activities in immuno-dermatology. The acquisition substantially accelerates our growth trajectory and enables synergies at organizational, financial, and commercial levels. Above and beyond that, UNION considers compounds from the PDE4 inhibitor compound series to have best-in-class potential for the treatment of psoriasis and other immune-dermatological disorders, with an overarching aim to address unmet medical needs”, said Rasmus Toft-Kehler, Chief Executive Officer of UNION.

Morten Sommer, Chief Scientific Officer, of UNION explains “Orismilast has demonstrated promising effects in clinical studies suggesting that it could become an attractive oral treatment option for patients with psoriasis and other immune-dermatological disorders. Our ambition, based on demonstrated potency levels, is to develop orismilast as a best-in-class PDE4 inhibitor across multiple immune-related diseases. As a next step, UNION will finalize formulation efforts with orismilast and simultaneously evaluate priority indications for clinical advancement”.

Thorsten Thormann, Vice President, Global Research at LEO Pharma added “LEO Pharma has been working very closely with the UNION team and have been impressed with their approach and professionalism in dermatological drug development. Accordingly, when the strategic decision was taken to divest the LEO PDE4 inhibitor compound series and orismilast, UNION was an obvious partner of choice for LEO Pharma. We look forward to seeing the program moving forward for the benefit of patients in need of new treatment options”.

Under the agreement, UNION will pay upfront, development and commercial milestones of up to 200 million USD, plus low single-digit royalties on sales. As part of the transaction, LEO Pharma also becomes a minority shareholder in UNION therapeutics.

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.

About LEO Pharma A/S
The company is a leader in medical dermatology with a robust R&D pipeline, a wide range of therapies and a pioneering spirit. Founded in 1908 and owned by the LEO Foundation, LEO Pharma has devoted decades of research and development to advance the science of dermatology, setting new standards of care for people with skin conditions. LEO Pharma is headquartered in Denmark with a global team of 6,000 people, serving 92 million patients in 130 countries.


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

JW Communications
Julia Wilson
Tel: +44 781 8430877
Email: communications@uniontherapeutics.com

 

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  • Niclosamide has been identified as a potent inhibitor of SARS-Cov-2 by Institut Pasteur Korea, with potency >40x higher than remdesivir
  • UNION has leveraged existing deep knowledge of niclosamide, derivatives and formulation technologies to rapidly advance a treatment candidate for COVID-19
  • The Danish Medicines Agency has approved UNIONs Clinical Trial Application to initiate study with niclosamide in healthy volunteers
  • The COVID-19 program has been awarded financial support from the Innovation Fund Denmark


COPENHAGEN, Denmark: UNION therapeutics A/S (“UNION”), a privately held clinical stage pharmaceutical company dedicated to the discovery and development of novel medicines for patients with unmet medical needs in inflammatory and infectious diseases, announced this morning that the Danish Medicines Agency has approved initiation of a clinical study with an optimized salt form of niclosamide as a new treatment candidate for COVID-19.

Chief Medical Officer of UNION, Dr Philippe Andres states: “The approval of our Clinical Trial Application is a major milestone, enabling us to further assess the safety and tolerability profile of UNI911 which has the potential to be a uniquely differentiated treatment candidate for COVID-19”.

Over a number of years, UNION has built a deep understanding of niclosamide and its mechanism of action. Professor Morten Sommer, Chief Scientific Officer and Co-founder of UNION, explains: “Niclosamide is a truly differentiated candidate for the treatment of COVID-19, with its method of action, effectively blocking replication of SARS-CoV-2 by targeting host cells to disrupt the viral life cycle. The extensive experience and data generated to date by UNION with niclosamide, and in particular optimized salt forms thereof, have enabled rapid progress leading to the successful approval of the Clinical Trial Application”.

CEO and Co-founder of UNION, Dr. Rasmus Toft-Kehler concludes: “UNION has been through an amazing period of process leading to approval of the Clinical Trial Application. The team, including all stakeholders, partners, physicians, Innovation Fund Denmark, The European Investment Bank, global organizations, investors and not least regulatory authorities, have acted with passion and in concert to advance UNI911 at an incredible pace. We are honored to be part of this venture and excited to be at the cusp of initiating clinical studies with the ultimate goal of making a differentiated product available for patients in need”.

UNION is conducting the first human study at the Zelo Phase I Unit at Bispebjerg and Frederiksberg Hopsital as well as Center for Physical Activity Research at Rigshospitalet, in collaboration with Trial Nation Denmark and the Technical University of Denmark, and with financial support from the Innovation Fund Denmark.

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

About UNION:
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 a versatile new mode-of-action chemistry platform, including well-characterized compounds as well as new chemical entities. The leadership team of UNION has successfully developed multiple approved drugs. UNION is headquartered in Copenhagen (Denmark) and managed by an experienced team across Europe and the USA. UNION has received financial support from the European Investment Bank’s InnovFin program under Horizon 2020. Visit the Company’s website at https://uniontherapeutics.com

About niclosamide
Niclosamide is approved as an oral anthelmintic. UNION has been working 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 inflammatory and infectious diseases.

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.

This press release contains forward-looking statements. Forward-looking statements are statements that are not historical facts and can be identified by words such as committed, will, steps, may, can, portfolio, planned, advancing, look forward, expected, or similar words. These forward-looking statements are based upon current expectations, estimates, believed potentials and can, therefore, involve risks and uncertainties. Many of these risks and uncertainties can be difficult to predict and could be out of the control of UNION therapeutics A/S. We may not actually achieve our intended plans, and you should not place undue reliance on these forward-looking statements

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  • Niclosamide identified as the most potent FDA approved inhibitor of SARS-Cov-2 by Institut Pasteur Korea
  • Potency of niclosamide >25x higher than chloroquine and >40x higher than remdesivir
  • UNION has extensive knowledge with niclosamide and formulation technology to be deployed in a new potential treatment of COVID-19
  • COVID-19 development program being prepared for submission to the Danish medical authorities

COPENHAGEN, Denmark: UNION therapeutics A/S (“UNION”), a privately held clinical stage pharmaceutical company dedicated to the discovery and development of novel medicines for patients with unmet medical needs in inflammatory and infectious diseases, today announced the launch of a program to test an optimized salt form of niclosamide as a treatment of COVID-19, in collaboration with Institut Pasteur Korea.

Researchers at Institut Pasteur Korea, an infectious disease-focused research institute, have identified niclosamide as the most potent FDA approved inhibitor of SARS-Cov-2 (the virus causing COVID-19) based on in vitro studies, while also having superior potency to the leading programs in development (e.g. remdesivir by Gilead and chloroquine) by 25-40-fold*.

Dr. Wang-Shick Ryu, CEO of Institut Pasteur Korea, states: “I am glad that our experimental finding on the antiviral effect of niclosamide can be immediately translated into COVID-19 therapy. I am impressed by the fact that UNION therapeutics is moving so quickly towards clinical development. It is our hope that the novel formulation ofniclosamide could help to contain the COVID-19 outbreak.”

UNION has worked with niclosamide and the related chemical class for more than five years and is currently conducting a Phase 2b study with niclosamide in atopic dermatitis patients. In recent years, UNION 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.

Professor and CSO and co-founder at UNION, Morten Sommer states: “The data from Institut Pasteur Korea confirmed the anti-viral potency of niclosamide in the context of SARS-CoV-2. Combined with our knowledge about the compound’s features, mechanism of action, and favorable safety profile, we consider it to be a promising candidate for treating COVID-19, and believe we can leverage our existing data for an accelerated development program”.

Professor Jutta Heim, Board member of UNION and member of the scientific advisory committee of GARDP, founded by WHO and DNDi, concludes: “The biotech and pharmaceutical industry needs to stand together in their response to this urgent crisis. Accordingly, I am very pleased that UNION can contribute with what I consider a unique and promising program for potential treatment of COVID-19”.

UNION is working towards a submission of the development program to the regulatory authorities.

For inquiries contact:
UNION therapeutics: Morten Boesen, +45 2381 5487 / info@uniontherapeutics.com

* Source: https://www.biorxiv.org/content/10.1101/2020.03.20.999730v2.full.pdf

About Institut Pasteur Korea:
Institut Pasteur Korea (IPK) is an international infectious disease-focused research institute dedicated to address global health issues with a combination of cutting-edge approaches in order to understand disease mechanisms and develop new treatments. By promoting multi-disciplinary projects, IPK is at the forefront of drug discovery and contributes to Korea’s future scientific resources through research, education and technological innovation. IPK is a private, non-profit foundation with four core missions of public interest – Research, Education, Public Health, and Translation of biomedical discoveries to improve health via technology transfer and industrial partnerships.

About UNION:
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 of a versatile new mode-of-action chemistry platform, including well-characterized compounds as well as new chemical entities. 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.

This press release contains forward-looking statements. Forward-looking statements are statements that are not historical facts and can be identified by words such as committed, will, steps, may, can, portfolio, planned, advancing, look forward, expected, or similar words. These forward-looking statements are based upon current expectations, estimates, believed potentials and can, therefore, involve risks and uncertainties. Many of these risks and uncertainties can be difficult to predict and could be out of the control of UNION therapeutics A/S. We may not actually achieve our intended plans, and you should not place undue reliance on these forward-looking statements

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  • Multi-national, double-blinded, and vehicle-controlled study
  • Study expected to enroll approximately 210 patients

COPENHAGEN, Denmark: UNION therapeutics A/S (“UNION”), a privately held clinical stage pharmaceutical company dedicated to the discovery and development of novel medicines for patients with unmet medical needs in inflammatory and infectious diseases, today announced the First Patient First Visit in a Phase 2b dose-ranging study evaluating the safety and efficacy of ATx201 OINTMENT in adult and adolescent patients with mild-to-moderate atopic dermatitis.

“Atopic dermatitis is a debilitating disease affecting the lives of millions of patients and their families. Despite it being the most common form of eczema, the current treatments continue to be characterized by a trade-off between efficacy and safety. We hope to be able to break this trade-off with ATx201 OINTMENT, and believe it could become a new mainstay treatment for atopic dermatitis”, states Rasmus Toft-Kehler, CEO of UNION.

“The mechanism of action of ATx201 is novel, making it a new class of treatment for inflammatory diseases and differentiating it from the products on the market as well as in development. Our initial clinical and preclinical studies have generated support for the mechanism of action to be well suited for treatment of atopic dermatitis. We are therefore very excited to initiate this study as an important step towards helping the many patients with atopic dermatitis”, states Professor Morten Sommer, Chief Scientific Officer of UNION.

“Despite positive advancements in recent years, the medical need for new treatment solutions for atopic dermatitis is very significant, and I look forward to seeing the data for ATx201”, says Jacob Thyssen, Clinical Professor in Dermatology at Copenhagen University and Herlev-Gentofte Hospital, and Principal Investigator in Denmark on the study.

ATx201 Phase 2b study
The randomized, double-blinded, vehicle-controlled, parallel group Phase 2b study is designed to evaluate the safety and efficacy of ATx201 OINTMENT as a monotherapy and to establish the dosing regimen for a potential Phase 3 program in patients with mild-to-moderate atopic dermatitis. The study is expected to enroll approximately 210 patients aged 12 years and older with mild-to-moderate atopic dermatitis. The study is conducted at sites in three countries in the European Union. The study will evaluate two active treatment groups compared to a placebo (vehicle) treatment group for 6 weeks, with patients randomized in a 1:1:1 fashion:

  • Treatment group 1: Twice-daily treatment with 4% ATx201 OINTMENT
  • Treatment group 2: Twice-daily treatment with 7% ATx201 OINTMENT
  • Treatment group 3: Twice-daily treatment with placebo (vehicle)

The primary end-point of the study is the mean change in Eczema Area Severity Index (EASI) from baseline to week 6. Secondary end-points include a number of other efficacy measures as well as patient reported outcomes.

About UNION:
UNION is a privately held, clinical stage, pharmaceutical company dedicated to the development of novel treatments for inflammatory and infectious diseases. The company is working of a versatile new mode-of-action chemistry platform. The leadership team of UNION has successfully developed multiple approved drugs on the market. UNION is headquartered in Copenhagen (Denmark) and managed by a global team across Europe and USA.

This press release contains forward-looking statements. Forward-looking statements are statements that are not historical facts and can be identified by words such as committed, will, steps, may, can, portfolio, planned, advancing, look forward, expected, or similar words. These forward-looking statements are based upon current expectations, estimates, believed potentials and can, therefore, involve risks and uncertainties. Many of these risks and uncertainties can be difficult to predict and could be out of the control of UNION therapeutics A/S. We may not actually achieve our intended plans, and you should not place undue reliance on these forward-looking statements

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