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Open Orphan Chairman Cathal Friel speaks to BRR Media re the new contract, other developments and the CEO’s departure
Open Orphan PLC’s (LON:ORPH) Cathal Friel speaks to Rosie Riall at BRR Media after signing a new deal with a US biotech for the provision of a respiratory syncytial virus human challenge study. Cathal also covers the channel pipeline, the hVIVO quarantine centre, flu and malaria vaccines and the planned departure of CEO Trevor Phillips.
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: Flu vaccine data showcased in peer reviewed article – Proactive Investors
by Ian Lyall. 
FLU-v has been developed by Imutex, 49%-owned by Open Orphan unit hVIVO
The results of a successful phase IIb trial of a potential flu vaccine being developed by an Open Orphan PLC (LON:ORPH) joint-venture have been written up in a peer-reviewed article carried by a scientific journal.
The data from FLU-v 004 challenge study underlined its ability to reduce mild-to-moderate symptoms of the illness.
FLU-v has been developed by Imutex, 49%-owned by Open Orphan unit hVIVO, as the first ‘universal’, broad-spectrum influenza vaccine.
The publication of the results in the periodical ‘npj Vaccines’ follows hard on the heels of results from a separate field assessment of the drug, which revealed “cellular and humoral immunogenicity” from a single dose of adjuvanted FLU-v.
In other words, the jab immediately provoked an immune response.
Imutex, meanwhile, is scheduling meetings with regulators on both sides of the Atlantic ahead of further trials.
“Progression to larger phase III studies with FLU-v can further describe the cellular immune response and evaluate how the vaccine interacts with influenza disease,” said Open Orphan chief executive Trevor Phillips.
Chairman Cathal Friel added: “The need for better, more broadly protective vaccines against influenza is a high priority worldwide, and few new vaccines have demonstrated efficacy in humans as seen in the results of the challenge study for FLU-v 004.
“This is the first universal influenza vaccine that has shown this protection from influenza and reduction of symptoms in late-stage studies and together with the highly statistical immune results reported in a peer review article earlier this week means that the risk of failure in a phase III setting is greatly reduced compared with entering into phase III studies with no efficacy data.”
Link here to view the original Proactive article
Open Orphan #ORPH – Publication of positive FLU-v vaccine challenge study results in journal
Positive results from FLU-v vaccine challenge study (FLU-v 004), the second Phase IIb study of FLU-v, which has been developed by Imutex Limited, hVIVO’s 49% joint venture with the SEEK Group, have now been published in a peer review journal
FLU-v is a first-in-class ‘universal’, broad spectrum, standalone, influenza vaccine candidate
- The publication in ‘npj Vaccines’ reported that one dose of FLU-v induced statistically significant reduction in mild to moderate influenza disease (MMID) defined as detection of viral shedding with at least one influenza symptom – reduction in confirmed influenza and symptoms
- One dose of FLU-v also induced a statistically significant reduction in the number of subjects experiencing 2 or more influenza symptoms compared to placebo
- This report follows recent publication of positive FLU-v Phase IIb field study results (FLU-v 003) demonstrating cellular and humoral immunogenicity of a single dose of adjuvanted FLU-v in 175 individuals
- The npj Vaccines article concludes that the T-cell strategy employed by FLU-v has potential to offer protection against influenza infection as a vaccine and that larger studies can evaluate how the vaccine interacts with influenza strains in different cohorts
- Imutex is currently scheduling meetings with key regulatory authorities, FDA and EMEA, hoping to gain confirmation of the remaining development pathway to approval for FLU-v
16 March 2020: Open Orphan plc (ORPH), the 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, today announces publication of positive results of a Phase IIb challenge study of FLU-v 004 (Study 004, NCT03180801) in npj Vaccines. The headline results from this study were previously announced by hVIVO on 10 January 2019. FLU-v is being developed by Imutex Limited, hVIVO’s 49% joint venture with PepTcell Limited, trading as the SEEK Group (“SEEK”).
The primary endpoint was achieved in the Phase IIb challenge study conducted by hVIVO using the National Institute of Allergy and Infectious Diseases (NIAID) Flu virus strain, methodology and analysis as a result of a collaboration between SEEK and the NIAID. The randomised, double-blind, placebo-controlled, single-centre, phase IIb efficacy and safety trial was designed and led by Matthew J. Memoli, M.D., NIAID. It was conducted in 153 healthy individuals between 18-55 years of age. They were randomised to receive one or two doses of adjuvanted FLU-v or adjuvanted placebo subcutaneously on days -43 and -22, prior to intranasal challenge on day 0 with the A/California/04/2009/H1N1 human influenza A challenge virus. The challenge virus strain was developed, tested and supplied by Dr. Memoli and co-workers from NIAID’s Laboratory of Infectious Diseases. The primary objective of the study was to identify a reduction in mild to moderate influenza disease (MMID) defined as having an influenza-like symptom with a confirmed influenza virus. Single dose adjuvanted FLU-v recipients (n=40) were significantly less likely to develop MMID after challenge vs placebo (n=42) (32.5% vs 54.8% p=0.035). The authors concluded that FLU-v should continue to be evaluated and cellular immunity explored further as a possible important correlate of protection against influenza. Additional endpoints were also achieved, including a statistically significant reduction in the number of volunteers who experienced two or more symptoms. Also, FLU-v performed better than placebo, although not to statistical significance, in a number of other key endpoints such as median duration of symptoms and severity of disease as measured by an NIAID-developed FLU-PRO questionnaire, as well as reduction in the mean total number of symptoms and mean peak symptoms, and total viral shedding.
Trevor Phillips, CEO of Open Orphan, said:
“Publication of these positive results for the second FLU-v Phase IIb study (FLU-v004; challenge study) follow on from the publication earlier this week of the FLU-v 003; field study, results.
The results demonstrate that T-cell immunity against conserved regions of the influenza virus is an important component for “universal*” vaccine strategies. Progression to larger Phase III studies with FLU-v can further describe the cellular immune response and evaluate how the vaccine interacts with influenza disease.
The efficacy of FLU-v in this wild-type human influenza challenge study (FLU-v 004) along with the supporting data from previous trials in the field, should be further examined in larger field trials where efficacy of FLU-v can be evaluated against a broader set of influenza strains and wider spectrum of disease. Along with our partner SEEK we have confidence in the potential of FLU-v as a universal flu vaccine and we are in the process of requesting meetings to continue discussions with the key regulatory authorities on the pathway for completing development of this exciting product opportunity.”
Cathal Friel, Executive Chairman of Open Orphan, said:
“The need for better, more broadly protective vaccines against influenza is a high priority worldwide, and few new vaccines have demonstrated efficacy in humans as seen in the results of the challenge study for FLU-v 004. This is the first universal influenza vaccine that has shown this protection from influenza and reduction of symptoms in late-stage studies and together with the highly statistical immune results reported in a peer review article earlier this week means that the risk of failure in a Phase III setting is greatly reduced compared with entering into Phase III studies with no efficacy data.
As previously stated, the additional investment or cost associated with commercialising FLU-v, will come from out-licencing the final stages of development including Phase III, to potential major international pharmaceutical companies, in Europe, North America and China. We remain excited about the potential for FLU-v and in a time when vaccine development is such a key focus globally.“
* A universal flu vaccine is one that is effective against all strains of the virus and does not require changing from year to year
Abstract: https://www.nature.com – DOI: 10.1038/s41541-020-0174-9. Efficacy of FLU-v, a Broad-Spectrum Influenza Vaccine, in a Randomized Phase IIb Human Influenza Challenge Study
Abstract:
FLU-v, developed by PepTcell (SEEK) is a novel peptide vaccine aiming to provide a broadly protective cellular immune response against influenza A and B.
Primary objective: To identify a reduction in mild to moderate influenza disease (MMID) defined as the presence of viral shedding and clinical influenza symptoms.
Design: Randomized, double-blind, placebo-controlled, single-center, phase IIb efficacy and safety trial. (ClinicalTrials.gov:NCT03180801, EudraCT: 2016-002134-74)
Setting: hVIVO Services Ltd (London, UK)
Participants: 153 healthy individuals 18-55 years.
Intervention: One or two doses of adjuvanted FLU-v or adjuvanted placebo subcutaneously on days-43 and-22, prior to intranasal challenge on day 0 with the A/California/04/2009/H1N1 human influenza A challenge virus.
Results: Single dose adjuvanted FLU-v recipients (n=40) were significantly less likely to develop MMID after challenge vs placebo (n=42) (32.5% vs 54.8% p=0.035).
Primary Funding Source: This research was funded in part by the Intramural Research Program of the NIH, NIAID as well as a CRADA with SEEK
Registration: NCT03180801, EudraCT: 2016-002134-74
For further information please contact
Open Orphan plc
Cathal Friel, Executive Chairman +353 (0)1 644 0007
Trevor Phillips, Chief Executive Officer +44 (0)20 7347 5350
Arden Partners plc (Nominated Adviser and Joint Broker) +44 (0)20 7614 5900
John Llewellyn-Lloyd / Benjamin Cryer
Davy (Euronext Growth Adviser and Joint Broker) +353 (0)1 679 6363
Anthony Farrell
Camarco (Financial PR) +44 (0)20 3757 4980
Tom Huddart / Daniel Sherwen
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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 the Coronavirus 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. 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 #ORPH – Publication of Positive Results in Journal
Positive results from Phase IIb field study of FLU-v vaccine (FLU-v 003), which has been developed by Imutex Limited, hVIVO’s 49% joint venture with the SEEK Group. FLU-v is a first-in-class ‘universal’, broad spectrum, standalone, influenza vaccine candidate and the results have now been published in a peer review journal
- The publication in the Annals of Internal Medicine journal concluded adjuvanted FLU-v is immunogenic and merits Phase III development to explore efficacy
- Compelling data package from two Phase II studies shows that a single dose of adjuvanted FLU-v induces cellular and antibody responses (FLU-v 003) and that it has a clinical impact in reducing disease, symptom and viral load (FLU-v 004)
- Imutex currently scheduling meetings with key regulatory authorities, FDA and EMEA, hoping to gain confirmation of the remaining development pathway to approval for FLU-v
10 March 2020: Open Orphan plc (ORPH) the 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, today announces publication of positive results of a Phase IIb field study of FLU-v 003 (Study 003, NCT02962908) in the Annals of Internal Medicine journal. The headline results from this study were previously announced by hVIVO on 18 June 2018. FLU-v is being developed by Imutex Limited, hVIVO’s 49% joint venture with the SEEK Group.
The Primary and secondary endpoints were achieved in a Phase IIb study, done within the UNISEC* Consortium and funded by the European Commission under the Seventh Framework Programme for Research and Technological Development (FP7). 175 healthy adults were randomly assigned to either an injection of adjuvanted (1 dose) or nonadjuvanted (2 doses) FLU-v or adjuvanted or nonadjuvanted placebo to compare the safety, immune response, and exploratory efficacy of different formulations and dosing regimens. They found that a single dose of adjuvanted FLU-v elicited a greater immune response compared with placebo. Adverse events were mostly mild to moderate injection site reactions. The authors conclude that a Phase III trial is warranted to explore efficacy.
*Universal Influenza Vaccines Secured, European Union funded consortium for the advancement of universal influenza vaccines.
Trevor Phillips, CEO of Open Orphan, said:
“FLU-v is a universal influenza vaccine that targets conserved internal regions of the flu virus. There have been two positive Phase II studies; FLU-v 003, testing immunogenicity and FLU-v004, testing efficacy in a human challenge study. Both Phase II studies, FLU-v 003 and FLU-v 004 are externally supported by UNISEC and NIAID (National Institute of Allergy and Infectious Diseases, part of the U.S. National Institutes of Health) respectively which gives strong external endorsement from key EU and US organisations. The full results from this positive Phase II immunogenicity study underscores both our, and our partner SEEK’s, confidence in the potential of FLU-v as a universal flu vaccine.
The advantages of FLU-v over the seasonal flu vaccine are that the composition of the FLU-v vaccine will remain the same year after year and it is manufactured synthetically, enabling year-round manufacturing and thus, increasing the number of doses available worldwide. It will not be subject to a strict vaccination window as is the case with seasonal flu vaccines. Also, being a universal vaccine, it should provide protection against new strains of flu virus which the seasonal flu vaccine is not able to do.
Imutex continues to explore options for the FLU-v vaccine programme and is scheduling meetings with key regulatory authorities, FDA and EMEA, hoping to gain further insight into Phase III preparation, a key area of interest expressed by potential partners.”
Cathal Friel, Executive Chairman of Open Orphan, said:
“The market potential for a broad spectrum universal influenza vaccine is significant and has become increasingly important and valuable in recent weeks when governments around the world are finally waking up and realising that universal flu vaccines need to be commercialised and there must be a better way forward than reliance on the traditional annual flu vaccination process which has variable efficacy, offers little protection against emerging strains and is available in limited quantities. A universal flu vaccine can and should be targeted at the entire population base. We now await publication of the positive results data from the NIAID FLU-v study (004) in a peer reviewed journal while still focusing on the Company’s strategy of achieving profitability in the near term and as we target the rapidly growing CRO pharmaceutical services sector.
As previously announced to the market, the newly enlarged Open Orphan group, of which hVIVO is a subsidiary of, is now very much targeted upon delivering a profitable pharmaceutical services business and will no longer be spending shareholders’ funds on the drug discovery processes. The additional investment or cost associated with commercialising FLU-v, will come from out-licencing the final stages including Phase III trials of FLU-v’s study, to major international pharmaceutical companies, in Europe, North America, and very importantly also in China. But we are increasingly excited about FLU-v potentially finally entering phase III clinical trials and now is one of the most opportune times to be doing that. “
Abstract: http://annals.org/aim/article/doi/10.7326/M19-0735
Immunogenicity, Safety, and Efficacy of a Standalone Universal Influenza Vaccine, FLU-v, in Healthy Adults
A Randomized Clinical Trial
Background: FLU-v is a broad-spectrum influenza vaccine that induces antibodies and cell-mediated immunity.
Objective: To compare the safety, immunogenicity, and exploratory efficacy of different formulations and dosing regimens of FLU-v versus placebo.
Design: Randomized, double-blind, placebo-controlled, single center phase 2b clinical trial. ClinicalTrials.gov: NCT02962908; EudraCT: 2015-001932-38
Setting: The Netherlands.
Participants: 175 healthy adults aged 18 to 60 years.
Intervention: 0.5-mL subcutaneous injection of 500 μg of adjuvanted (1 dose) or nonadjuvanted (2 doses) FLU-v (A-FLU-v or NA-FLU-v) or adjuvanted or nonadjuvanted placebo (A-placebo or NA-placebo) (2:2:1:1 ratio).
Measurements: Vaccine-specific cellular responses at days 0, 42, and 180 were assessed via flow cytometry and enzyme linked immunosorbent assay. Solicited information on adverse events (AEs) was collected for 21 days after vaccination. Unsolicited information on AEs was collected throughout the study.
Results: The AEs with the highest incidence were mild to moderate injection site reactions. The difference between A-FLU-v and A-placebo in the median fold increase in secreted interferon--γ (IFN-γ) was 38.2-fold (95% CI, 4.7- to 69.7-fold; P = 0.001) at day 42 and 25.0-fold (CI, 5.7- to 50.9-fold; P < 0.001) at day 180. The differences between A-FLU-v and A-placebo in median fold increase at day 42 were 4.5-fold (CI, 2.3- to 9.8-fold; P <0.001) for IFN-γ -producing CD4+ T cells, 4.9-fold (CI, 1.3- to 40.0-fold; P < 0.001) for tumour necrosis factor-α (TNF-α), 7.0-fold (CI, 3.5- to 18.0-fold; P < 0.001) for interleukin-2 (IL-2), and 1.7-fold (CI, 0.1- to 4.0-fold; P = 0.004) for CD107a. At day 180, differences were 2.1-fold (CI, 0.0- to 6.0-fold; P = 0.030) for IFN-γ and 5.7-fold (CI, 2.0- to 15.0-fold; P < 0.001) for IL-2, with no difference for TNF-α or CD107a. No differences were seen between NA-FLU-v and NA-placebo.
Limitation: The study was not powered to evaluate vaccine efficacy against influenza infection.
Conclusion: Adjuvanted FLU-v is immunogenic and merits phase 3 development to explore efficacy.
Primary Funding Source: SEEK and the European Commission Directorate-General for Research and Innovation, European Member States within the UNISEC (Universal Influenza Vaccines Secured) project.
Ann Intern Med. doi:10.7326/M19-0735
For further information please contact
Open Orphan plc
Cathal Friel, Executive Chairman +353 (0)1 644 0007
Trevor Phillips, Chief Executive Officer +44 (0)20 7347 5350
Arden Partners plc (Nominated Adviser and Joint Broker) +44 (0)20 7614 5900
John Llewellyn-Lloyd / Benjamin Cryer
Davy (Euronext Growth Adviser and Joint Broker) +353 (0)1 679 6363
Anthony Farrell
Camarco (Financial PR) +44 (0)20 3757 4980
Tom Huddart / Daniel Sherwen
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 the Coronavirus 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. 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 (c hemistry, 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.
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.”
Open Orphan #ORPH – New hVIVO contract signed with a European Biotech Company to provide RSV human challenge study
6 March 2020: Open Orphan plc (ORPH) the rapidly growing CRO specialist pharmaceutical services Group which has a focus on orphan drugs and is a world leader in the provision of virology and vaccine challenge study services, 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 £3.2m 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 £7m.
This contract demonstrates hVIVO, part of Open Orphan, successfully converting its pipeline and 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. These services are particularly relevant and topical in the environment of heightened awareness of virology following Covid-19. 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.
This breakthrough study reinforces hVIVO’s position as the leader in the provision of virology services.
Trevor Phillips, CEO of Open Orphan, said: “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. This agreement is the first agreement utilising what is now, a broader and complementary in-house service offering. All aspects of the study will be conducted within Open Orphan, leading to the elimination of sub-contractor costs and retain more contracted revenue. We look forward to delivering the work for a European Biotech Company and further developing our relationship.”
Cathal Friel, Executive Chairman of Open Orphan, said: “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. 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.“
For further information please contact
Open Orphan plc
Cathal Friel, Executive Chairman +353 (0)1 644 0007
Trevor Phillips, Chief Executive Officer +44 (0)20 7347 5350
Arden Partners plc (Nominated Adviser and Joint Broker) +44 (0)20 7614 5900
John Llewellyn-Lloyd / Benjamin Cryer
Davy (Euronext Growth Adviser and Joint Broker) +353 (0)1 679 6363
Anthony Farrell
Camarco (Financial PR) +44 (0)20 3757 4980
Tom Huddart / Daniel Sherwen
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 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 the Coronavirus 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. 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 (c hemistry, 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.
About RSV
RSV is a highly contagious viral disease and is one of the most common causes of bronchiolitis and pneumonia. It is the number one cause of childhood hospitalisation both in the United States and around the world. Nearly all children are infected with the virus at least once by the age of 2-3 years. The disease is particularly dangerous for premature babies, children with other health conditions and the elderly. Many children develop pulmonary disease and/or asthma from RSV that persists throughout adult life making them susceptible to re-infection. Currently, there are no approved vaccines for RSV.
Open Orphan #ORPH – Appointment of new Director
Open Orphan , the 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 , is pleased to announce, further to its announcement of 13 February 2020, the appointment to the board of Leo Toole as Chief Financial Officer.
Leo Toole brings over 20 years’ experience in senior finance roles in Pharmaceuticals, Medical Technology and FMCG sectors. He has held senior finance positions at Procter and Gamble, ResMed and Sublimity Therapeutics. Through positions in multinational companies across Europe and in the venture capital space in the UK and Ireland, he has extensive experience in building finance teams, corporate development, equity and debt financing, public markets, and mergers and acquisitions. Leo is a Business graduate of Trinity College Dublin, Ireland and HEC Liège, Belgium. He also holds an MBA with Distinction from INSEAD in France and Singapore.
Cathal Friel, Executive Chairman of Open Orphan commented: “We are delighted to welcome Leo Toole to the board following the successful completion of his regulatory due diligence checks. Leo brings with him a wealth of experience which will be invaluable to us at what is an exciting time for Open Orphan as we steer the company to profitability in the coming months and increasing deal flow and revenue in the year ahead, he is a great addition to the board. These are exciting times for Open Orphan because following the acquisition of hVIVO we are now the world leader in the provision of viral challenge study models and, as such, we are ideally positioned to provide assistance and help to vaccine manufacturers and governments around the world to successfully deal with and in the search for solutions to the Coronavirus outbreak.”
The following additional information is provided in accordance with paragraph (g) of Schedule Two to the AIM Rules for Companies and paragraph (g) of Schedule Two of the Euronext Growth Rules for Companies:
Full Name: Leo Patrick Toole
Age: 46
|
Current directorships / partnerships |
Directorships / partnerships within the last five years |
|
Meadow Landscape Design Limited |
Sublimity Therapeutics Holdco Limited |
|
Venn Life Sciences (NI) Ltd |
Arvonage Limited |
Leo Toole does not hold any shares or options in the Company.
There is no further information to be disclosed in relation to Leo Toole’s appointment pursuant to AIM Rule 17, paragraph (g) of Schedule Two of the AIM Rules for Companies or paragraph (g) of Schedule Two of the Euronext Growth Rules for Companies.
For further information please contact
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Open Orphan plc Cathal Friel, Executive Chairman Trevor Phillips, Chief Executive Officer |
+353 (0)1 644 0007 +44 (0)20 7347 5350 |
|
Arden Partners plc (Nominated Adviser and Joint Broker) John Llewellyn-Lloyd / Benjamin Cryer |
+44 (0)20 7614 5900 |
|
Davy (Euronext Growth Adviser and Joint Broker) Anthony Farrell |
+353 (0)1 679 6363 |
|
Camarco (Financial PR) |
|
|
Tom Huddart / Daniel Sherwen |
+44 (0)20 3757 4980 |
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 the Coronavirus 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. 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 (c hemistry, 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 #ORPH presents at ShareSoc Growth Company Seminar, Manchester
Open Orphan, the 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 has Europe’s only 24 bedroom quarantine clinic with onsite virology lab in Queen Mary’s Hospital London, is pleased to announce that the Company will be attending and presenting at the ShareSoc Growth Company Seminar on February 25, 2020 at DoubleTree by Hilton Hotel, One Piccadilly Place, 1 Auburn Street, Manchester M1 3DG.
Cathal Friel, Open Orphan’s Executive Chairman will be presenting from 18:40 onwards to update existing and potential investors on the Company’s business plans for 2020.
The event will provide an opportunity for investors to hear about the progress being made by the Company following the acquisition of hVIVO and the potential for Open Orphan as it moves rapidly forward rapidly. hVIVO, is a world leader in the provision of viral challenge studies, vaccine and viral laboratory services ,and supports product development for customers developing antivirals, vaccines and respiratory therapeutics, all of which are particularly relevant and topical in the environment of heightened awareness in light of the current outbreak of coronavirus disease (COVID-19).It also has Europe’s only commercial 24 bed quarantine clinic and on site virology laboratory at Queen Mary’s Hospital in London.
A link to our investor presentation is already available on our website at https://www.openorphan.com/sites/openorphan/files/Open_Orphan_Investor_Deck_0120_1.pdf
Additionally, a link to the video of Open Orphan’s presentation will be made available on the Company website following the event.
For further information on the Shares Investor Evening and registration, please visit the event website https://www.sharesoc.org/events/sharesoc-growth-company-seminar-in-manchester-25-february-2020/
No new material information will be disclosed at this event.
Enquiries:
Open Orphan Plc Tel: +353 1 5499 341
Cathal Friel, Executive Chairman +353 (0)1 644 0007
Trevor Phillips, Chief Executive Officer +44 (0)20 7347 5350
Arden Partners (Nominated Adviser and Joint Broker) Tel: +44 (0)20 7614 5900
John Llewellyn-Lloyd / Ruari McGirr / Benjamin Cryer
Davy (Euronext Growth Adviser and Joint Broker) Tel: +353 (0)1 679 6363
Anthony Farrell (Corporate Finance)
Camarco (Financial PR) Tel: +44 (0)20 3757 4980
Tom Huddart / Billy Clegg / Daniel Sherwen
About RNS Reach announcements
This is an RNS Reach announcement. RNS Reach is an investor communication service aimed at assisting listed and unlisted (including AIM quoted) companies to distribute non-regulatory news releases into the public domain. Information required to be notified under the AIM Rules for Companies, Market Abuse Regulation or other regulation would be disseminated as an RNS regulatory announcement and not on RNS Reach.
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 the Coronavirus 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. No other company in the world has such a portfolio, with only two competitors globally having 1 challenge study model each.
Open Orphan #ORPH – Appointment of Group Chief Financial Officer
Open Orphan, the 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 has Europe’s only 24 bedroom quarantine clinic with onsite virology lab in Queen Mary’s Hospital London, is pleased to announce the appointment of Leo Toole to the role of Group Chief Financial Officer with immediate effect. Leo was previously Interim Chief Financial Officer of Open Orphan plc and Finance Director of the Open Orphan division following the merger with hVIVO.
It is Open Orphan’s intention that Leo be appointed to the Board of Open Orphan as soon as possible, subject to the satisfactory completion of regulatory due diligence checks.
Leo Toole brings over 20 years’ experience in senior finance roles in Pharmaceuticals, Medical Technology and FMCG sectors. He has held senior finance positions at Procter and Gamble, ResMed and Sublimity Therapeutics. Through positions in multinational companies across Europe and in the venture capital space in the UK and Ireland, he has extensive experience in building finance teams, corporate development, equity and debt financing, public markets, and mergers and acquisitions. Leo is a Business graduate of Trinity College Dublin, Ireland and HEC Liège, Belgium. He also holds an MBA with Distinction from INSEAD in France and Singapore.
Commenting on the appointment, Trevor Phillips, CEO of Open Orphan said:
“We are pleased to confirm Leo as the permanent CFO of Open Orphan. Leo brings relevant industry experience and public market experience to the Company and we look forward to him joining the PLC board upon the completion of his regulatory due diligence checks.”
Cathal Friel, Executive Chairman of Open Orphan said:
“I am delighted that we have appointed Leo as CFO. He has worked with Open Orphan for the past year and is therefore well placed to assist with the rapid integration of hVIVO, deliver on our synergies programme and target profitability in the near term. We feel he is an important addition the executive team as we target the rapidly growing CRO pharmaceutical services sector.”
For further information please contact:
Open Orphan plc
Cathal Friel, Executive Chairman
Trevor Phillips, Chief Executive Officer
+353 (0)1 644 0007
+44 (0)20 7347 5350
Arden Partners plc (Nominated Adviser and Joint Broker)
John Llewellyn-Lloyd / Benjamin Cryer
+44 (0)20 7614 5900
Davy (Euronext Growth Adviser and Joint Broker)
Anthony Farrell
+353 (0)1 679 6363
Camarco (Financial PR)
Tom Huddart / Daniel Sherwen
+44 (0)20 3757 4980
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 the Corona virus 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 Chronic Constructive Pulmonary Disease viral challenge models. No other company in the world has such a portfolio, with a Belgian company having 1 and one with the west coast of America also having 1 challenge study model. 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 capturing 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.