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Merger Of Simbec & Orion Corporation To Create A New International Full-Service CRO



6/23/2014 8:24:10 AM

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• Creation of an international CRO with complete service offering from Phase I to Phase IV post-authorisation studies
• Appointment of a highly experienced Board, including Professor Trevor Jones CBE, Chairman, Ronald Openshaw, Chief Executive Officer and Professor Sir Christopher Evans, Non-Executive Director
• Completed with £12.5m of funds raised from Welsh Arthurian Life Sciences Fund and HSBC Bank plc
• Rationale for the merger is to create a platform for buy and build strategy and to deliver business synergies

23 June 2014: The Boards of Simbec Research Limited (“Simbec”), the specialist CRO in Early Stage Clinical Development, and ORION Clinical Services Limited (“ORION”), the specialist CRO in Late Stage Clinical Development, are pleased to announce the merger of the two companies. The Group will be known post completion as Simbec-Orion Group Limited (“Simbec-Orion” or the “Group”) and both the Simbec and ORION brands will continue in their respective fields.

The merger has created a full service international contract research organisation (CRO) with capabilities in both Early Stage Clinical Development and Late Stage Clinical Development with deep expertise in oncology and rare and orphan diseases. The Group, with combined revenues of approximately £25m, employs approximately 250 staff and has operations across Europe, Australia and the United States together with capabilities in multiple other territories. Simbec-Orion will maintain its headquarters in the UK based in Merthyr Tydfil, South Wales.

Simbec-Orion will offer its current 65 large and mid-cap pharmaceutical and biotech clients a complete service offering from first in human exploratory clinical pharmacology studies, through Phase II and Phase III studies. Currently the Group has approximately 90 clinical trials running for clients. In addition, the Group offers its clients Phase IV post authorisation studies for marketing, observational and post authorisation safety studies (“PASS”). These are complemented by in-house dedicated Central Laboratory facilities (Bioanalytics and Pathology) to rapidly, accurately and reliably read and interpret samples from all clinical trials conducted in-house as well as providing support services to its clients for additional samples and to smaller CROs without an in-house capability. In addition, Simbec-Orion can now offer a comprehensive service offering in Regulatory Affairs, Pharmacovigilance (both clinical and post marketing), Medical Affairs, and Central Pharmacy all serviced by an in-house capability.

The merger was completed through the provision of £12.5m of funds raised from the Welsh Arthurian Life Sciences Fund and HSBC Bank plc’s West and Wales Corporate team which provided debt finance in this leveraged transaction. Simbec was advised by Lucia Capital LLP, Geldards LLP and PriceWaterhouseCoopers LLP. ORION was advised by EY’s Life Sciences Corporate Finance team and Shoosmiths LLP. Arthurian Life Sciences was advised by Eversheds. HSBC Bank plc was advised by Osborne Clarke.

It is the Board’s and the funders’ intention to pursue a buy and build strategy to invest in existing operations, to drive organic growth and to rapidly pursue further acquisitions to expand its geographic reach, service offering and therapeutic areas of clinical excellence.

Upon completion of the merger the Board of Directors will be joined by Ronald Openshaw as Chief Executive Officer, who joins from Lucia Capital LLP, and by Dr Fabrice Chartier as its new Chief Operating Officer, previously Director of Scientific Affairs of ORION. The Board is completed by its existing Directors Professor Trevor Jones, Non-Executive Chairman; Howard Jenkins, Managing Director; Dr Trevor Tanner, Chief Scientific Officer; and Professor Sir Christopher Evans, Non-Executive Director. At completion, Dr Alan Irvine, CEO ORION Clinical Services, has agreed to assume the role of Group Chief Medical Officer.

Commenting on the merger, Professor Trevor Jones, Chairman, Simbec-Orion, said: “Simbec is proud of its 30 year history of excellence in Early Stage Clinical Development. We are delighted to complete the merger with ORION which takes our Welsh headquartered company onto an international stage and expands its capability into Late Stage Clinical Development.”

Ronald Openshaw, Chief Executive Officer, Simbec-Orion, said: “It is a privilege to join the Group as its new CEO. These two companies have traditions to be proud of. I look forward to driving the growth of the business as we invest in the Group, and to our expansion through further acquisitions. Our goal is to increase our leadership position as a trusted member of a client’s team to meet their needs as they create new medicines to improve human health.”

Howard Jenkins, Managing Director of the Group, said: “Trevor Tanner and I have directed Simbec Research over the past eleven years to create a world leader in Early Stage Clinical Development. The completion of the merger with ORION will provide continuity in our clients’ clinical development program and create a world class full service Clinical Research Organisation”.

Dr Alan Irvine, CEO, ORION Clinical Services, said: “Fabrice Chartier and I founded ORION 17 years ago to create a CRO with a depth of expertise in oncology and rare and orphan diseases. We have already built a good relationship with Simbec and its team and are confident of the future for our staff and our company. The merger with Simbec expands our capabilities allowing us to meet our clients’ needs from the start of clinical development to registration and beyond.”

Professor Sir Christopher Evans, Chairman of Arthurian Life Sciences Ltd, said: “My investment management team at Arthurian Life Sciences first backed Simbec in 2013. Together with HSBC we are today delighted to be leading this transaction and look forward to supporting further acquisitions for the new combined Simbec-Orion Group.”

Edwina Hart MBE AM, Minister for Economy, Science and Transport, said: “The Welsh Government has been delighted with the growth of Simbec over the past year since Arthurian made the initial investment from our Wales Life Sciences Fund. This merger with ORION is particularly exciting and creates a Group with approximately 250 employees with a true international reach from its headquarters in Wales. We are proud to be backing such an important transaction.”

For more information, please contact:

Consilium Strategic Communications
Mary-Jane Elliott
Amber Bielecka
Ivar Milligan
Tel: +44 (0)20 3709 5700
SimbecOrion@consilium-comms.com

Simbec-Orion Group
Ronald Openshaw, Chief Executive Officer
Peter MacLennan, Head of Business Development
Tel: +44(0)800 691995
Tel: +44(0)1753 578080

Arthurian Life Sciences
Professor Sir Christopher Evans
Martin Walton
Brenig Preest
Tel: +44 (0)783 329 6175
enquiry@arthurianlifesciences.co.uk

HSBC Bank plc
Craig Grant
Tel: +44 (0) 8455 839816
craiggrant@hsbc.com

EY
David Scourfield
Andrew Jones
Drew Wightman
+44 (0)20 7951 2000

Information about Simbec Research Limited

Simbec is a specialist Early Stage Clinical development business focused on phase I healthy volunteer, first in human and first in patient studies. It was founded in 1976 and has an international reputation for excellence in this field.

At the group’s headquarters in Merthyr Tydfil, Wales it houses a dedicated 48 bed clinic facility to conduct those critically important first in human studies in a secure, high quality controlled environment. It is capable of undertaking studies ranging from single visit one-day trials to those lasting upwards to as much as 44 continuous days. Simbec recruits volunteers across Wales and South West of England and can complete studies rapidly due to this pool of available volunteers.

Also at this location are the group’s Central Laboratories equipped with state of the art facilities for the rapid testing, analysis and quantification of, biomarkers, safety and pharmacokinetic samples from clinical studies. Often providing near real time same-day results.

This facility also houses the group’s Central Pharmacy capable to prepare investigational medicinal product for human clinical trials. The Group will invest in these facilities to deliver greater capacity as demand increases, handling drug product for Late Stage Clinical Development.

Information about ORION Clinical Services Limited

ORION is a specialist CRO focused on Clinical Development in Phases I, II, and III with capabilities in Phase IV marketing, observational, and post authorization safety studies.

ORION has considerable expertise in oncology, rheumatology, anaesthesia, dermatology as well as rare and orphan diseases. It has recruited experienced Project Managers and CRAs with a depth of knowledge in these indications to provide exceptionally high quality support to its clients in these fields.

To support its clinical capability ORION offers its clients Regulatory Affairs & Medical Writing, Data Management and Biostatistics. ORION’s Pharmacovigilance services offer clients support both in the clinical development phase and also now services clients in a seamless fashion providing post-authorisation marketing pharmacovigilance support.

ORION’s is based in Greater London-UK, Paris-France, Cologne-Germany, Rome-Italy, Princeton-USA and Melbourne-Australia.

ORION combines this therapeutic expertise and geographic reach with a highly personalised service and a keen focus on the needs of each individual project. This approach offers their pharmaceutical and biotech clients a competitive advantage to complete trials to the highest standards and in the shortest practicable timeframes.

Board & Management team

Professor Trevor Jones, Chairman
Trevor Jones will continue in his role as Non-Executive Chairman, a position he has held in Simbec since May 2013. Professor Jones has had an outstanding career in the international pharmaceutical industry. He is a Non-Executive Director of Allergan Inc (USA), and the international CRO Synexus Ltd also a member of the Board of VeronaPharma plc. He is a visiting professor at King’s College, London and holds honorary degrees and Gold Medals from 6 universities. From 1987-94, he was a main board director of The Wellcome Foundation, where he was responsible for R&D including the development of AZT, Zovirax, Lamictal, Malarone and other medicines.

Professor Jones is a founder member of the Geneva-based, Public / Private Partnership, Medicines for Malaria Venture (MMV) and in 2004 was appointed to the World Health Organisation (WHO) Commission on Intellectual Property Rights, Innovation and Public Health (C.I.P.I.H). For 12 years, he was a member of The UK Government regulatory agency The Medicines Commission.

He was Director General of the Association of the British Pharmaceutical Industry (ABPI) a member of Council of IFPMA and the Board of EFPIA for 10 years until September 2004. He was a member of the UK Government Advisory Group on the Human Genome and, until 2008, Chair of the UK Government Advisory Group on Genetics Research.

In 2005 Professor Jones won the SCRIP Life Time Achievement award for his contribution to the pharmaceutical sciences and industry, and he was honoured by Her Majesty Queen Elizabeth II by the award of CBE in the 2003 New Year's Honours List.

Professor Sir Christopher Evans, Non-Executive Director
Sir Chris is the founder and Chairman of Excalibur Group, and is a highly successful scientist and entrepreneur, having built over 50 medical companies and created more than $5bn of value for investors with $3bn of cash exits. He is the founder of Chiroscience, Celsis, Biovex, Merlin, Vectura and Piramed. Has also raised $2bn for cancer research projects. More recently, he has established Arthurian Life Sciences Limited to provide management services to the Wales Life Science Investment Fund, a £100 million fund and a key part of the Welsh Governments Life Sciences Initiative.

Ronald Openshaw, Chief Executive Officer
Ronald was appointed CEO of Simbec-Orion upon completion. He is a partner in Lucia Capital LLP a strategic advisory firm which he founded in 2008.

He has previously been CEO of Plethora Solutions Holdings PLC, a urology and sexual health specialty pharmaceutical company, which he led during its successful reacquisition of its lead drug PSD502 and its approval by the European Medicines Agency. Prior to that he was also Chief Executive Officer of Pharmagene plc / Asterand plc up to 2007 leading it through that successful merger and refocusing the business.

He spent a significant period of his career as a senior investment banker in the healthcare and life sciences sector with each of Jefferies and earlier Panmure Gordon & Co. After graduating in Physics he spent six years with KPMG where he qualified as a Chartered Accountant.

Dr Fabrice Chartier, Chief Operating Officer
Fabrice was the Scientific Director of ORION. He co-founded ORION in 1997, and today is in charge of global Clinical Operations (Europe, North America, Australia). Prior to ORION, Fabrice was director and member of the board of a European CRO based in Paris before joining one of its key clients, Laboratoires Fournier. In Fournier Fabrice was Head of the Clinical Research Unit in Paris, before he was asked to set-up a Clinical Research Unit in the UK specialised in oncology and immunology, still for Fournier. Fabrice received his PhD in Biochemistry and Molecular Genetics in Paris VI University, France and he has a total of 25 years professional experience in team management and international clinical development. Dr Trevor Tanner, Chief Scientific Officer
Dr Tanner completed his PhD studies in neurochemistry at The London School of Pharmacy (1976) and became a University of Wales Research Fellow in The Welsh School of Pharmacy (1976 – 1978) undertaking research into the interaction of amino acid and catecholamines neurotransmitters. He was appointed Head of Bioassay Development at The Wellcome Foundation (1978-1981). He joined Simbec Research in 1981 to establish GLP and GCP systems, progressed within Simbec Research Ltd to manage all Phase I activities and specialise in study design, pharmacokinetics, pharmacodynamics, data management and applied statistics for early stage clinical trials. He became an Executive Director and major shareholder at Simbec research in 2003, Executive Board member of Altasciences (2008) and Executive Board member of Simbec Research Ltd (2013).

Howard Jenkins, Managing Director
Howard Jenkins has held the post of Managing Director at Simbec since re-acquiring the company from its Canadian parent in May 2013 with backing of the Wales Life Sciences Investment Fund. Director of Finance/Company Secretary for Simbec Holdings Ltd. and Simbec Research Ltd. 2003 to 2012, and Simbec Scintigraphics Ltd. from 2003 to 2006, Altasciences main board observer 2008 to 2012. Howard gained a Master of Business Administration (MBA) with overall distinction from the University of Glamorgan, also achieving distinction for his post graduate dissertation: “Perceived Service Quality and Behavioural Response in the context of Clinical Research Outsourcing in the Pharmaceutical Industry”. Graduate of Cardiff Business School Leadership Development Programme in 2005, member of the Institute of Directors since 2011.

Dr Alan Irvine, Chief Medical Officer
Alan will serve as CMO of Simbec-Orion post completion. He was co-founder, CEO and CMO of ORION.

He previously spent 14 years in multinational pharmaceutical companies where he successfully held senior board level positions being responsible for medical affairs, development and regulatory affairs.

He is a co-founding member of CREN (Clinical Research Expert Network), ABPI, a member of the MHRA working party on Risk Adaptive Study Design Methodology and a member of the HRA Collaboration and Development Steering Group (HRA is the Health Research Authority, a part of the DoH).

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