Tag Archives: chemistry manufacturing and control

Open Orphan plc (AIM: ORPH), a rapidly growing specialist pharmaceutical services CRO and a world leader in vaccine and antiviral testing using human challenge clinical trials, announces a further contract renewal with a major top-3 global pharmaceutical client extending its consultancy services to end of December 2021. This follows on from the announcement made on 22 December 2020 regarding the same client and demonstrates the repeat business that Venn Life Sciences continues to win from its long-term clients.

The Venn team in the Breda office in the Netherlands, will provide Chemistry, Manufacturing & Control (“CMC”) consultancy services to this leading global pharmaceutical client for one of the client’s vaccine development programmes and follows the recently announced contract renewal for work on two of the client’s vaccine development programmes. This successful collaboration has been extended until end of December 2021.

Cathal Friel, Executive Chairman of Open Orphan, said:  “We are delighted to enter 2021 with another contract signed by the Venn team in Breda with this top-3 global pharmaceutical client. Venn have been providing CMC support to this top tier company since 2012 and are pleased to be continuing to work with this client in their vaccine development programme.

“This contract demonstrates the depth of vaccine development knowledge across the Company and, in addition to being the world leader in vaccine and antiviral testing using human challenge clinical trials, reinforces our position as the go-to clinical research organisation for many other services required by both large pharma and vaccine developers at all stages of development.”

For further information please contact:

About Open Orphan ( www.openorphan.com )

Open Orphan is a rapidly growing niche CRO pharmaceutical services company which is a world leader in the testing of vaccines and antivirals through the use of human challenge clinical trials. Conducted from Europe’s only 24-bedroom quarantine clinic with onsite virology providing individually isolated rooms and connected to our specialist laboratory facility.  hVIVO’s challenge studies require healthy volunteers to take part, volunteers are recruited through FluCamp, learn more at  www.FluCamp.com .  The hVIVO facility offers highly specialised virology and immunology laboratory services to support pre-clinical and clinical respiratory drug, antiviral, and vaccine discovery and development.  Reliable laboratory analysis underpinned by scientific expertise is essential when processing and analysing clinical samples. Robust quality processes support our team of scientists in the delivery of submission ready data. 

The Company 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 number of Coronavirus challenge study models and expects to be helping many COVID-19 vaccine development companies to test their vaccines. No other company in the world has such a portfolio, with only two competitors globally having 1 challenge study model each.  hVIVO also works with companies in the UK and Ireland to provide COVID-19 testing to staff to protect staff and customers from a workplace COVID-19 outbreak through its  COVID Clear  offering.  

Open Orphan comprises of two commercial specialist CRO services businesses,  hVIVO    and    Venn Life Sciences and is also building out a valuable data platform business. hVIVO has built up one of the world’s largest databases of infectious disease progression data and we are populating our Open Orphan Health Data platform with this historical hVIVO data. In our clinical trials going forward, we are also planning to collect data on volunteer’s via wearables during clinical trials. Therefore, Open Orphan’s data, which may yield valuable digital biomarkers, could be one of the more sought-after datasets by many of the large wearables /smart watch wearables providers around the world. 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 is an integrated drug development consultancy firm which 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 plc (AIM: ORPH), a rapidly growing specialist pharmaceutical services CRO and a world leader in vaccine and antiviral testing using human challenge clinical trials, announces a contract renewal extending its consultancy services with a major top-3 global pharmaceutical client to December 2021.

Through the Venn Life Sciences team in the Breda office in the Netherlands, Open Orphan provides independent, up-to-date and hands-on Chemistry, Manufacturing & Control (“CMC”) consultancy services to a leading global pharmaceutical client and has done since 2012.   Venn’s CMC consultancy team provide essential support for two of this client’s vaccine development programmes and these successful collaborations have been extended until December 2021.

Venn’s CMC consultancy services focus on the strategic and technical aspects of pharmaceutical development and support the management of pharmaceutical development programmes covering small molecules and biologicals from chemical or cell line development up to submission of marketing authorisation application. 

Cathal Friel, Executive Chairman of Open Orphan, said: “This contract renewal underpins our confidence in delivering against ambitious growth targets for 2021 and securing strong revenue visibility moving forward. Open Orphan’s strengths lie in the established relationships we have with our pharmaceutical partners and we expect to continue to extend these relationships as well as focussing on converting the existing pipeline of new business opportunities we have before us.

“Market consensus forecast a significant increase in revenues in 2021. As we remain on target to be operationally profitable in the final quarter of this year, we also expect to see a significant impact on earnings next year from this revenue growth.”

For further information please contact

About Open Orphan ( www.openorphan.com )

Open Orphan is a rapidly growing niche CRO pharmaceutical services company which is a world leader in the testing of vaccines and antivirals through the use of human challenge clinical trials. Conducted from Europe’s only 24-bedroom quarantine clinic with onsite virology providing individually isolated rooms and connected to our specialist laboratory facility.  hVIVO’s challenge studies require healthy volunteers to take part, volunteers are recruited through FluCamp, learn more at  www.FluCamp.com .  The hVIVO facility offers highly specialised virology and immunology laboratory services to support pre-clinical and clinical respiratory drug, antiviral, and vaccine discovery and development.  Reliable laboratory analysis underpinned by scientific expertise is essential when processing and analysing clinical samples. Robust quality processes support our team of scientists in the delivery of submission ready data.

The Company 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 number of Coronavirus challenge study models and expects to be helping many COVID-19 vaccine development companies to test their vaccines. No other company in the world has such a portfolio, with only two competitors globally having 1 challenge study model each.  hVIVO also works with companies in the UK and Ireland to provide COVID-19 testing to staff to protect staff and customers from a workplace COVID-19 outbreak through its  COVID Clear  offering.  

Open Orphan comprises of two commercial specialist CRO services businesses,  hVIVO    and    Venn Life Sciences and is also building out a valuable data platform business. hVIVO has built up one of the world’s largest databases of infectious disease progression data and we are populating our Open Orphan Health Data platform with this historical hVIVO data. In our clinical trials going forward, we are also planning to collect data on volunteer’s via wearables during clinical trials. Therefore, Open Orphan’s data, which may yield valuable digital biomarkers, could be one of the more sought-after datasets by many of the large wearables /smart watch wearables providers around the world. 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 in January 2020. Venn is an integrated drug development consultancy firm which 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.