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Open Orphan #ORPH – £5.1m RSV Human Challenge Study Contract Win
Open Orphan (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, has signed a £5.1m contract with a biopharmaceutical company to test its Investigational Medicinal Product (IMP) using hVIVO’s respiratory syncytial virus (RSV) Human Challenge Study Model.
The study is due to commence in H2 2022, with the revenue from the contract being recognised across 2021 and 2022. hVIVO will conduct this study on behalf of this biopharmaceutical client to demonstrate the efficacy of its IMP against RSV infection.
RSV is a contagious virus that affects the respiratory tract of children and at-risk older adults; in severe cases, it can cause pneumonia and other life-threatening breathing difficulties. RSV is a significant public health threat and is one of the leading causes of hospitalisation of young children across the world. It also poses a significant threat to at-risk older adults; in the current climate, RSV may also lower immunity and increase the risk of developing COVID-19, and where these infections occur together, it can worsen the severity of COVID-19 illness.
hVIVO has two decades of experience and expertise in safely conducting challenge studies across a range of respiratory viruses, including RSV, various strains of Influenza, human Rhinovirus HRV (common cold virus), malaria, and asthma. In October 2020, this expanded to include the SARS-CoV-2 virus.
Cathal Friel, Executive Chairman of Open Orphan said: “We are pleased to have signed this contract to test our client’s product using our RSV Human Challenge Study Model. It is testament to our position as the world leading provider of Phase IIa human challenge study clinical trials that innovative biopharmaceutical companies, as well as Big Pharma, are actively and regularly engaging us to test their novel vaccine and antiviral candidates.
“RSV is one of several infectious and respiratory disease areas of unmet need that we are seeing rapidly growing interest in from drug developers. We look forward to working with more companies across the world to test their antivirals and vaccines, as Phase IIa human challenge studies increasingly become 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:
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Open Orphan plc |
+353 (0) 1 644 0007 |
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Cathal Friel, Executive Chairman |
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Arden Partners plc (Nominated Adviser and Joint Broker) |
+44 (0) 20 7614 5900 |
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John Llewellyn-Lloyd / Louisa Waddell |
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finnCap plc (Joint Broker) |
+44 (0) 20 7220 0500 |
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Geoff Nash / James Thompson/ Richard Chambers |
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Davy (Euronext Growth Adviser and Joint Broker) |
+353 (0) 1 679 6363 |
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Anthony Farrell |
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Walbrook PR (Financial PR & IR) |
+44 (0)20 7933 8780 or openorphan@walbrookpr.com |
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Paul McManus/ Sam Allen/ Louis Ashe-Jepson |
+44 (0)7980 541 893/ +44 (0) 7502 558 258 / +44 (0) 7747 515393 |
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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 and its state-of-the-art 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. There has been an explosion in the growth of the infectious disease pharmaceuticals market, which is estimated to grow to in excess of $250bn by 2025. The Group is focused on refreshing its existing challenge models and develop new models, such as Malaria, to address the dramatic growth potential of the global infectious disease market.
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.
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.
Open Orphan #ORPH – £7.5m Human Challenge Study Contract
Open Orphan (AIM: ORPH), a rapidly growing specialist pharmaceutical services clinical research organisation (CRO) and world leader in vaccine and antiviral testing using human challenge clinical trials , announces that hVIVO , a subsidiary of Open Orphan, has entered into a contract with a biotechnology company to run a human viral challenge study for a respiratory syncytial virus (“RSV”) prophylactic and treatment.
This US biotechnology company is developing a product for the prevention and treatment of acute and chronic respiratory syncytial virus infections. RSV is a contagious virus that affects the respiratory tract of children and at-risk older adults; in severe cases, it can cause pneumonia and other life-threatening breathing difficulties. RSV is a significant public health threat and is one of the leading causes of hospitalisation of young children across the world. It also poses a significant threat to at-risk older adults; in the current climate, RSV may also lower immunity and increase the risk of developing COVID-19, and where these infections occur together, it can worsen the severity of COVID-19 illness. There is currently no prophylactic or specific treatment on the market for RSV.
The total contract value is £7.5m and the study is due to commence in Q4 2021, with the majority of revenues being recognised in 2021. hVIVO will conduct this study on behalf of its client to demonstrate the efficacy of their lead candidate against RSV infection. The product is expected to have substantial advantages with respect to potency, safety, tolerability and convenience while fully maintaining efficacy when compared to other similar products.
Cathal Friel, Executive Chairman, said: “This is another substantial and significant contract win for hVIVO and Open Orphan. Through signing these deals, we continue to reinforce our position as the clear world leader in human challenge studies. Over the past year, Open Orphan has fully restructured, reorganised, and integrated our London, Paris and Breda operations to become a fast-growing, profitable provider of human challenge clinical trials in a manner required by the global pharmaceutical and biotechnology companies. We have expanded from one clinic to multiple clinics, and it is our stated objective to continue to invest and expand our global capability to ensure our position as the world leader in testing vaccines, antivirals, and monoclonal antibodies through the use of human challenge studies well into the future.
With the ongoing expansion of our clinical footprint, we can now provide any pharmaceutical company, anywhere in the world, rapid access to challenge study clinical trials to gather data on their product in a relatively short time period. In the past, human challenge studies suffered from the perception that it was difficult to find a provider and that it may take a long period of time to complete, however, Open Orphan is transforming this view. We are delighted to see human challenge clinical trials now becoming an increasingly important part of pharmaceutical product testing and commercialisation.
hVIVO is currently the only company worldwide that can facilitate RSV challenge studies and we are in advance negotiations with all the significant RSV vaccine and drug developers globally. Our multiple state-of-the-art East London quarantine facilities are well equipped to carry out this study in a safe and controlled clinical environment.”
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 .
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 (“MAR”). With the publication of this announcement via a Regulatory Information Service, this inside information is now considered to be in the public domain.
For further information please contact:
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Open Orphan plc |
+353 (0) 1 644 0007 |
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Cathal Friel, Executive Chairman |
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Arden Partners plc (Nominated Adviser and Joint Broker) |
+44 (0) 20 7614 5900 |
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John Llewellyn-Lloyd / Benjamin Cryer / Dan Gee-Summons |
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finnCap plc (Joint Broker) |
+44 (0) 20 7220 0500 |
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Geoff Nash / James Thompson/ Richard Chambers |
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Davy (Euronext Growth Adviser and Joint Broker) |
+353 (0) 1 679 6363 |
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Anthony Farrell |
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Walbrook PR (Financial PR & IR) |
+44 (0)20 7933 8780 or openorphan@walbrookpr.com |
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Anna Dunphy / Paul McManus |
+44 (0)7876 741 001 / +44 (0)7980 541 893 |
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Notes to Editors
Open Orphan plc
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 which also has a highly specialised virology and immunology laboratory on-site. Open Orphan has a leading portfolio of eight human challenge study models for conditions such as RSV, flu, asthma and COPD. In addition, Open Orphan is also developing the world’s first COVID-19 human challenge study model as part of the Human Challenge Programme and has signed a reservation contract with the UK Government for the first three COVID-19 vaccine challenge studies.
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.
Open Orphan #ORPH Exec Chairman Cathal Friel speaks to Proactive’s Andrew Scott about the new US biotech deal
Open Orphan PLC’s (LON:ORPH) Cathal Friel speaks to Proactive London’s Andrew Scott after signing a new deal with a US biotech for the provision of a respiratory syncytial virus human challenge study.
Open Orphan #ORPH – Major New Contract Signed With US Biotech Company for RSV Human Study & CEO Trevor Phillips to Step Down.
Open Orphan plc (ORPH) the rapidly growing specialist CRO pharmaceutical services company which has a focus on orphan drugs and is the world leader in the testing of vaccines and antivirals using human challenge study models, is pleased to announce the signing of a new contract with a US biotechnology Company for the provision of a respiratory syncytial virus (RSV) human challenge study.
Highlights:
- Challenge study projected to deliver £3.5 million in revenue in 2020
- Utilising complementary in-house Clinical Research Organisation (“CRO”) services of hVIVO and Venn Life Sciences (“Venn”) following completion of merger with hVIVO
- Trevor Phillips to stand down as CEO. Strong management team in place with Cathal Friel, continuing as Executive Chairman and running the business alongside a leadership team focused on delivering growth at a very exciting time for the Company
Major New Contract with US Biotechnology Company
The company has signed a contract with a US Biotech company for the provision of an RSV human challenge study with work to deliver the study expected to commence shortly. The contract is projected to deliver £3.5 million in revenue all of which is expected to be recognised in 2020. The signing of this new contract follows the signing in March of this year of another RSV human challenge contract, now underway, for an initial £3.2 million.
This contract represents continued conversion of Open Orphan’s substantial pipeline, generation of significant cash flow and further validates its position as world leader in the provision of viral challenge studies, vaccine and viral laboratory services, supporting product development for customers developing antivirals, vaccines and respiratory therapeutics. These services are particularly relevant and topical in environment of heightened awareness of virology following the onset of Covid-19.
This study will commence in hVIVO’s unique London-based quarantine unit in the third quarter of 2020, which is Europe’s only commercial 24-bed quarantine clinic with on-site virology laboratory. hVIVO is the only company globally with the capability to run an RSV human challenge study.
This agreement utilises what is now a broader and complementary in-house service offering. All aspects of the study will be conducted within Open Orphan, with data management, biostats and medical writing being provided by our Venn Life Sciences colleagues leading to the elimination of sub-contractor costs and retention of more contracted revenue. We look forward to delivering the work for this US Biotech Company and further developing our relationship.
Directorate Change
Trevor Phillips is standing down as CEO and, to ensure an orderly transition, he will remain in his role until the end of June but leaves the Board with immediate effect. Trevor was brought into hVIVO in 2017 at a critical time for the business and successfully completed the restructuring and repositioning the business and its strategy. Recently, Trevor led the hVIVO team during its successful completion of the merger with Open Orphan plc, expanding the specialist CRO provision and positioning the Company for profitability.
Cathal Friel, Executive Chairman, will continue to lead the Company alongside a refreshed, focused management team and Board. The Company has also recently formed an advisory board chaired by Professor John Oxford, Professor at Queen Mary’s University London and one of the world’s leading experts on global diseases such as influenza, including bird flu, SARS, MERS and Coronavirus, to help support customers’ product development and the Company’s response to Covid-19.
Cathal Friel, Executive Chairman of Open Orphan, said:
“Firstly, I would like to thank Trevor for his help merging Open Orphan and hVIVO. Trevor had previously successfully right sized and focused hVIVO and our refreshed management team is now focused on delivering growth at a very exciting time for the Company.
“The signing of this new £3.5 million contract with a US Biotechnology Company is further evidence of this exciting time as we successfully convert Open Orphan’s pipeline of prospects into formal customer contracts. Open Orphan will be utilising its complementary in-house CRO services of hVIVO and Venn to deliver this contract. This contract demonstrates the Open Orphan and hVivo group’s focus on building long term contracts with recurring revenues to deliver future profitability while ensuring rationalising the business and reduce costs.”
Trevor Phillips, CEO of Open Orphan, said:
“This is an exciting time for Open Orphan, I wish the company well. It was an honour to have led hVIVO and its staff through the business turnaround and with the merger completed I leave the Company in a stronger position as it enters its next phase of growth.”
ENDS
For further information please contact
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Open Orphan plc |
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Cathal Friel, Executive Chairman |
+353 (0)1 644 0007 |
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Arden Partners plc (Nominated Adviser and Joint Broker) |
+44 (0)20 7614 5900 |
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John Llewellyn-Lloyd / Benjamin Cryer
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Davy (Euronext Growth Adviser and Joint Broker) |
+353 (0)1 679 6363 |
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Anthony Farrell
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Camarco (Financial PR) |
+44 (0)20 3757 4980 |
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Tom Huddart / Hugo Liddy |
Notes to Editors:
Open Orphan is a rapidly growing specialist CRO pharmaceutical services company which has a focus on orphan drugs and is a world leader in the provision of virology and vaccine challenge study services and viral laboratory services. It has Europe’s only 24-bedroom quarantine clinic with onsite virology lab in Queen Mary’s Hospital London. hVIVO supports product development for customers developing antivirals, vaccines and respiratory therapeutics, all particularly relevant and topical in the environment of heightened awareness of Covid-19 in 2020. The Company also has a leading portfolio of 8 viral challenge study models which are: 2 FLU, 2 RSV, 1 HRV, 1 Asthma, 1 cough and 1 COPD viral challenge models. As announced in early March, Open Orphan is rapidly advancing a Coronavirus challenge study model and expects to be very active with many companies in the development of a Covid-19 vaccine. No other company in the world has such a portfolio, with only two competitors globally having 1 challenge study model each.
Open Orphan comprises of two commercial specialist CRO services businesses (Venn and hVIVO) and is developing an early stage orphan drug genomics data platform business. This platform captures valuable genetic data from patient populations with specific diseases with designated orphan drug status and incorporating AI tools. In June 2019, Open Orphan acquired AIM-listed Venn Life Sciences Holdings plc in a reverse take-over and in January 2020 it completed the merger with hVIVO plc. Venn, as an integrated drug development consultancy, offers CMC (chemistry, manufacturing and controls), preclinical, Phase I & II clinical trials design and execution. The merger with hVIVO created a European full pharma services company broadening the Company’s customer base and with complementary specialist CRO services, widened the range of the Company’s service offerings.
Open Orphan tip of the year update on mega contract win
by Tom Winnifrith
Open Orphan (ORPH) was one of my tips of the year at a 4.6p offer. The shares are now 5.5p bid – the recent market sell off hitting it like nearly all other stocks. But the news today of a contract potentially worth £10 million plus really does slam home the message of how cheap the shares are.
There are currently no broker forecasts out there but that is something that I expect to change in the next few weeks. For what it is worth, in my late December share tip I wrote:
But it too has been hacking at its costs and would, I guess, have made it through to profitability in 2020 on a stand-alone basis. Put the two enterprises together and cut out some easy cost overlaps and you will create a business that will deliver, I reckon, sales this calendar year of c£30 million and a pre-tax profit of £2-3 million. And the next year those numbers could well be £40 million+ and £5 million. These are, I stress, my forecasts and the company is not allowed to comment on them or validate them, it is my work alone.
Ends.
Today’s news is, in the context of those forecasts, pretty stunning. We are told:
Open Orphan is pleased to announce the signing of a new contract with a European Biotech Company for the provision of a RSV human challenge study. The study is projected to deliver £3.2 million in revenue all of which is expected to be recognised in 2020. If the study is successful, it is anticipated that an additional follow-on larger pivotal challenge study will commence end Q4 2020, delivering significant further revenue and expected to be a minimum of £7 million
Ends.
So that is at least £3.2 million top line new business this year (possibly more) and potentially an eve bigger boost in the first half of next year. I am not altering my forecasts on the basis of today’s news but it is an indication that they are all the more credible.
In addition we are reminded, in the context of the Coronavirus pandemic that Open owns “Europe’s only commercial 24-bed quarantine clinic and on-site virology laboratory and is the only company globally with the capability to run an RSV human challenge study.” I’d imagine that it should be doing something of a roaring trade.
Open sits on net cash of c£5 million. At the current mid it is valued at just under £30 million so ex cash it trades on well under 1 times current year sales and on a PE of 8-12 falling to just 5. That is clearly far far too low and the shares remain a strong buy with a target of at least 10p if not more.
Link here to view on ShareProphets website
Irish Times – Open Orphan seals deal that could net more than €11.6m
by Colin Gleeson
Dublin-listed pharma group announces contract with European biotech company
Dublin-listed pharma services company Open Orphan has announced the signing of a new contract with a European biotech company that could yield it more than £10 million in revenue this year.
Open Orphan, a European-focussed, rare and orphan drug consulting services platform, informed the Irish stock exchange of the deal for the provision of an respiratory syncytial virus (RSV) human challenge study on Friday.
The study with the unnamed company is projected to deliver £3.2 million (€3.7m) in revenue, all of which is expected to be delivered in 2020.
If the study is successful, it is anticipated that an additional follow-on larger pivotal challenge study will begin at the end the year, delivering significant further revenue and expected to be a minimum of £7 million.
Open Orphan is the result of executive chairman Cathal Friel reversing his pharma services business of the same name into Dublin-listed drug clinical trials manager Venn Life Sciences last year.
The company said the contract demonstrates Hvivo, which it acquired last year, “successfully converting its pipeline”.
The deal also “reinforces its position as world leader in the provision of viral challenge studies, vaccine and viral laboratory services, supporting product development for customers developing antivirals, vaccines and respiratory therapeutics”.
It said these services are “particularly relevant” in the environment of heightened awareness of virology as the world grapples with the Covid-19 virus.
London-based Hvivo is unique as it has Europe’s only commercial 24-bed quarantine clinic and on-site virology laboratory and is the only company globally with the capability to run an RSV human challenge study.
Open Orphan chief executive Trevor Phillips said the deal would eliminate sub-contractor costs of the study.
“This agreement continues to endorse the importance being placed on the use of viral challenge models supporting product development for companies developing antivirals, vaccines and respiratory therapeutics,” he said.
“All aspects of the study will be conducted within Open Orphan, leading to the elimination of sub-contractor costs and retain more contracted revenue.”
Open Orphan executive chairman Cathal Friel said the acquisition of Hvivo was reaping benefits for the company.
“This agreement demonstrates one of the benefits of the merger with Hvivo and the opportunity the broadened service offering provides in delivering a catalyst for significant revenue growth and margin expansion within the business,” he said.
“In the short term, the combination of Open Orphan and Hvivo is expected to result in substantial cost savings through the elimination of subcontractor costs where they can be replaced by new capabilities within the company.”