ORPH.L Regulatory News (ORPH)

Open Orphan plc

("Open Orphan" or the "Company")

£8.1m Asthma Human Challenge Study Contract Win

Open Orphan plc (AIM: ORPH), a rapidly growing specialist contract research organisation (CRO) and world leader in vaccine and antiviral testing using human challenge clinical trials, announces that hVIVO, a subsidiary of Open Orphan plc, has signed an £8.1m contract with a major global pharmaceutical company to test its inhaled human rhinovirus (hRV) antiviral product using the hVIVO Asthma Human Challenge Study Model, which uses a hRV challenge agent (common cold virus).

Asthma is a long-term condition that is characterised by inflammation and narrowing of the small airways of the lungs, which causes coughing, shortness of breath and chest tightness. 5.4 million people in the UK currently receive treatment for asthma. Illnesses such as the common cold, which is most commonly caused by HRV, can worsen symptoms.

This antiviral study will be conducted by hVIVO and is expected to commence in H1 2022. The Company expects the bulk of the revenue from this contract to be recognised across 2021 and 2022. This new contract further underlines the increased international focus and investment into respiratory and infectious diseases following the outbreak of COVID-19, in areas such as the common cold, Influenza, and many other areas which were previously underserved by the pharmaceutical industry.

hVIVO has two decades of experience and expertise in safely conducting challenge studies across a range of respiratory and infectious disease viruses, including various strains of influenza, RSV, HRV, Asthma and Malaria, etc.

Cathal Friel, Executive Chairman of Open Orphan, said: "We are pleased to sign this contract with this top five European pharmaceutical company to test its inhaled hRV antiviral product using our Asthma Human Challenge Study Model. This contract demonstrates how our broad range of challenge study models can support our clients' varied infectious and respiratory disease product pipelines, and adds to our exciting pipeline of RSV, hRV, Influenza, Malaria, and Asthma challenge study contracts.

"The COVID-19 pandemic has highlighted that for the past 30 years there has been very little investment into the infectious disease and respiratory products space. As such, when the pandemic arrived the world discovered that the medicine cabinet of infectious disease products to deal with COVID-19 was virtually empty. Post-pandemic, most governments across the world, all of the Big Pharma companies and many of the smaller pharma companies are now investing hugely in new infectious and respiratory disease products and as such, this market is expected to grow from $20bn in 2019 to $250bn by 2025. This restocking of the pharmaceutical industries medicine cabinet of infectious disease products around the world is now leading to an enormous expansion of investment into the infectious disease and respiratory product market and will be seen as one of the biggest growth opportunities in the history of the pharmaceutical industry.

"Having recently launched our Malaria Human Challenge Study Model, adding to our world leading portfolio of challenge study models, Open Orphan is now ideally situated to be one of the few companies in the world that can quickly and efficiently test a broad range of these new infectious and respiratory disease products in our human challenge clinical trial studies. Open Orphan is well placed to work with Big Pharma and biotechs alike to move their products through the clinic as human challenge becomes a part of mainstream clinical trial design."

The information contained within this announcement is deemed by the Company to constitute inside information as stipulated under the Market Abuse Regulations (EU) No. 596/2014 (as implemented into English law) ("MAR"). With the publication of this announcement via a Regulatory Information Service, this inside information is now considered to be in the public domain.

Interested in becoming a volunteer?

hVIVO recruits many of its volunteers for its challenge study clinical trials through its dedicated volunteer recruitment website, www.flucamp.com. By volunteering to take part in one of our studies in a safe, controlled, clinical environment under expertly supervised conditions you are playing your part to further medical research and help increase the understanding of respiratory illnesses.

Individuals interested in taking part in COVID-19 human challenge study research can learn more at www.UKCovidChallenge.com.

For further information please contact:

Notes to Editors

Open Orphan plc (London and Euronext: ORPH) is a rapidly growing pharmaceutical service/contract research company that is a world leader in testing vaccines and antivirals using human challenge clinical trials. The company provides services to Big Pharma, biotech and government/public health organisations.

Open Orphan runs challenge studies in London from both its 19-bedroom Whitechapel quarantine clinic, opened in February 2021, and its 24-bedroom QMB clinic with its highly specialised on-site virology and immunology laboratory. Open Orphan has a leading portfolio of human challenge study models for infectious and respiratory diseases and is developing a number of other models including the world's first COVID-19 human challenge study model as part of the Human Challenge Programme.

Building upon its many years of challenge studies and virology research, the Company is developing an in-depth database of infectious disease progression data. Based on the Company's Disease in Motion® platform, this unique dataset includes clinical, immunological, virological and digital (wearable) biomarkers. The Disease in Motion platform has many potential applications across a wide variety of end users including big technology, wearables, pharma and biotech companies. Following COVID-19 there is now a renewed interest and investment in infectious diseases.

Open Orphan's Paris office has been providing biometry, data management and statistics to its many European pharmaceutical clients for over 20 years. For over 15 years, the Company's Netherlands office has been providing drug development consultancy and services, including CMC (chemistry, manufacturing and controls), PK and medical writing, to a broad range of European clients. Both offices are now also fully integrated with the London office and working on challenge study contracts as well as supporting third party trial contracts.