Author: devadmin2

Dear Valued Clients, Partners and Industry Colleagues,

Ergomed plc shares its ardent compassion with the communities impacted worldwide by COVID-19. As the world responds to this pandemic, we remain committed to supporting you to ensure that the vital delivery of our work continues.

I’m writing to explain the necessary steps we are taking to protect the health and safety of our employees and their families, our customers, patients and communities. I also want to assure you that we are flexible and continually adapting to navigate this global health crisis. Our clinical research team is actively at the forefront of supporting potential effective therapy in the treatment of COVID-19.

The work they are doing is fully aligned with the company’s duty of care to society for pharmacovigilance as well as clinical research and it is truly impactful. We appreciate all the efforts being made across the company by all our staff in these challenging times.

As part of the continuous risk management process, Ergomed plc leadership team is evaluating regularly the potential impact of the outbreak on the business continuity, in particular planning and execution of clinical studies and pharmacovigilance support.

Health, safety & non-essential travel

The safety of our staff is our utmost priority. We have taken a number of measures aimed at protecting the welfare of our employees, and to minimize the risk of spreading the virus within our global office network.

Currently, more than 80% of our employees are working remotely with robust technologies in place, to ensure the safety of our staff as much as possible while effectively providing our services.

All non-business critical travel has been restricted – and we have enabled platforms to bridge our teams.

With evolving travel restrictions, our leadership is following governmental restrictions and evaluating all meetings to make cautious decisions to optimize virtual connections.

The Executive and Management Teams are meeting daily to discuss our Business Continuity Plan priorities.

Our business continuity and virtual work

The actions we are taking follow the advice from the WHO, the respective government guidance and health authorities.

We have considered several mitigation strategies, which may be implemented on a study by study basis, to ensure that we maintain appropriate oversight over the study conduct, patient safety and data integrity at all times.

We have provided options for remote monitoring in high-impact/restricted regions, and we have the ability to implement our remote monitoring as needed. Teams will be in direct contact with you to recommend the appropriate individual deployment strategy as needed.

All Ergomed plc Project Managers are performing a risk assessment for their studies to evaluate the potential impact on study deliverables and they are preparing study-specific strategies which will be shared with you during the following days.

Each pharmacovigilance Project Director working within our specialised PrimeVigilance business is conducting an impact analysis on their projects, to determine if additional measures are needed.

I am proud of the Ergomed Leaders who are facilitating new ways of working and collaborating under these challenging times. On behalf of Ergomed Plc, we value our relationship with you, the shared impact we can make for patients and their safety, and we are committed to providing the highest quality service.

Should you have specific questions, please reach out to your Ergomed plc business contact or via our regularly updated website (www.ergomedplc.com).

If there are significant changes to the approach we have taken, we will inform you as appropriate.

Thank you for your continued support.

Warm regards,

Miroslav Reljanovic
Executive Chairman
Ergomed plc

About Ergomed plc
Ergomed provides specialist services to the pharmaceutical industry spanning all phases of clinical trials, post-approval pharmacovigilance and medical information. Ergomed’s fast-growing, profitable services business includes a full range of high-quality contract research and trial management (CRO) services under the Ergomed brand together with an industry-leading suite of specialist pharmacovigilance (PV) solutions, integrated under the PrimeVigilance brand, and an internationally recognized specialist expertise in orphan drug development, under the PSR brand. To learn more about our worldwide specialist full-service CRO, visit: http://ergomedplc.com.

Ergomed is providing clinical research services for the study and has been integrally involved in the design and implementation of the study from a clinical and operational perspective.

Dr Miroslav Reljanović, Executive Chairman of Ergomed, said: “COVID-19 represents an unprecedented global healthcare challenge and the rapid evaluation of therapies which could alter the course of the infection and improve outcomes for patients is vital. Ergomed is proud to be making a contribution to this effort by bringing our proven capabilities and expertise to bear on this important study.”

The full text of the announcement issued by Papa Giovanni XXIII Hospital and EUSA on 18 March is as follows:

EUSA Pharma and the Papa Giovanni XXIII Hospital, Bergamo, Italy announce initiation of an observational case-control study of siltuximab in patients with COVID-19 who have developed serious respiratory complications

Hemel Hempstead, ENGLAND and Bergamo, ITALY– 18^th March 2020 – EUSA Pharma, a global biopharmaceutical company focused on oncology and rare disease, today announced the initiation of the Papa Giovanni XXIII Hospital sponsored study of siltuximab, an interleukin (IL)-6 targeted monoclonal antibody, for the treatment of patients with COVID-19 who have developed serious respiratory complications (Siltuximab In Serious COVID-19; SISCO Study). Ergomed plc (LSE: ERGO), a company focused on providing specialized services to the pharmaceutical industry, is providing clinical research services for the study.

Professor Alessandro Rambaldi, MD, PhD, Papa Giovanni XXIII Hospital, Bergamo, Italy, Study Sponsor-Investigator and Director of the Hematology Unit and Department of Oncology and Hematology, said: “The team at Papa Giovanni XXIII Hospital are thankful to EUSA Pharma for the supply of siltuximab for compassionate use in patients with serious complications of COVID-19 and the opportunity to generate data to understand the potential for IL-6 blockade in these patients. The SISCO Study will allow us to generate credible data as evidence to guide future treatment and research decisions and we look forward to publication of these data as quickly as possible. The Hospital is in a very difficult emergency situation and rapid collection and analysis of data by way of a case-control study will provide much needed  information to help address this critical situation and appropriately guide the use of medicines in an off-label situation.”

Lee Morley, Chief Executive Officer, EUSA Pharma, said: “We are delighted to support this study to investigate the potential for siltuximab to help patients severely ill as a result of COVID-19. Following the release of initial data from China suggesting a role of IL-6 in the development of Acute Respiratory Distress Syndrome as a result of COVID-19, EUSA Pharma was pleased to assist Papa Giovanni XXIII Hospital with the supply of siltuximab under compassionate use and to support the collection, analysis and publication of initial outcome data from this series of patients. We look forward to working further with the Hospital as well as Italian and Worldwide Regulatory Authorities, and other research bodies to fully understand the potential of siltuximab at this critical time in the global pandemic.”

About the SISCO Study

Sponsored by the Papa Giovanni XXIII Hospital, the SISCO Study is an observational case-control trial of siltuximab, a chimeric monoclonal antibody targeting human interleukin (IL)-6, for the treatment of patients infected with COVID-19 who develop serious respiratory complications.

The study represents the data collection and analysis of a series of patients treated under an ongoing emergency compassionate use protocol. The study will investigate two cohorts retrospectively, hospitalised patients prior to admission to an intensive care unit (ICU) or patients already requiring intensive care, and will compare to matched controls. Primary endpoints are reduction in the need of invasive ventilation, time spent in ICU or 30-day mortality.

Emerging evidence suggests that exacerbated production of the inflammatory cytokine IL-6 is associated with the severity of COVID-19 related pulmonary pathology associated with Acute Respiratory Distress Syndrome (ARDS). Therefore, direct targeting of this cytokine may improve clinical outcomes in these critically ill patients.

This study will provide important data to inform future clinical studies, discussions on which are ongoing, to further investigate the efficacy of siltuximab in patients with COVID-19 who develop serious respiratory complications. Initial data are expected in late March 2020.

ENDS

About siltuximab

Siltuximab is a monoclonal antibody that blocks the action of interleukin (IL)-6, a multifunctional cytokine detected at elevated levels in multiple inflammatory conditions.

It is approved by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) under the brand name of SYLVANT^®  for the treatment of patients with multicentric Castleman disease (MCD) who are human immunodeficiency virus (HIV) negative and human herpesvirus-8       (HHV-8) negative (idiopathic MCD; iMCD). iMCD is a rare, life-threatening and debilitating lymphoproliferative disorder, which causes abnormal overgrowth of immune cells and shares many symptomatic and histological features with lymphoma.

EUSA Pharma has exclusive rights to SYLVANT^® globally. EUSA Pharma has granted BeiGene, Ltd., exclusive development and commercialization rights to SYLVANT^® in Greater China.

Indications and Usage of SYLVANT^® – See full Prescribing Information for additional information.

SYLVANT^® (siltuximab) is indicated for the treatment of patients with multicentric Castleman disease (MCD) who are HIV negative and HHV-8 negative.

Limitations of Use: SYLVANT^® was not studied in patients with MCD who are HIV positive or HHV-8 positive because SYLVANT^® did not bind to virally produced IL-6 in a nonclinical study.

Contraindications: Severe hypersensitivity reaction to siltuximab or any of the excipients in SYLVANT^®.

Dosage and Administration

Administer SYLVANT^® 11 mg/kg over 1 hour as an intravenous infusion every 3 weeks until failure.

Perform hematology laboratory tests prior to each dose of SYLVANT^® therapy for the first 12 months and every 3 dosing cycles thereafter. If treatment criteria outlined in the Prescribing Information are not met, consider delaying treatment with SYLVANT^®. Do not reduce dose.

Do not administer SYLVANT^® to patients with severe infections until the infection resolves.

Discontinue SYLVANT^® in patients with severe infusion related reactions, anaphylaxis, severe allergic reactions, or cytokine release syndromes. Do not reinstitute treatment.

ENDS

Enquiries:

Ergomed plc	Tel: +44 (0) 1483 402 975
Miroslav Reljanović (Executive Chairman)
Richard Barfield (Chief Financial Officer)
Numis Securities Limited	Tel: +44 (0) 20 7260 1000
Freddie Barnfield / Huw Jeremy (Nominated Adviser)
James Black (Broker)
Consilium Strategic Communications – for UK enquiries	Tel: +44 (0) 20 3709 5700
Chris Gardner / Sue Stuart	ergomed@consilium-comms.com
Matthew Neal / Olivia Manser

About Ergomed plc

Ergomed provides specialist services to the pharmaceutical industry spanning all phases of clinical development, post-approval pharmacovigilance and medical information. Ergomed’s fast-growing, profitable services business includes an industry leading suite of specialist pharmacovigilance (PV) solutions, integrated under the PrimeVigilance brand, a full range of high-quality contract research and trial management services under the Ergomed brand (CRO), and an internationally recognised specialist expertise in orphan drug development, under PSR. For further information, visit: http://ergomedplc.com.

ERGOMED plc Press Release

Acquisition of Ashfield Pharmacovigilance Inc., a US pharmacovigilance services provider, from UDG Healthcare for $10 million

• Ashfield Pharmacovigilance Inc. becomes part of Ergomed’s PrimeVigilance division, bolstering its market-leading position as a global independent specialist pharmacovigilance provider and establishing a platform for the broader Ergomed services business in the US
• Combined business expands PrimeVigilance’s geographic coverage in the strategically important US market and strengthens global service offering
• Acquisition adds over 40 new clients to PrimeVigilance and a strong order book of contracted future revenues of $9.8 million
• Ashfield Pharmacovigilance Inc. reported $11.6 million revenue and $0.9 million adjusted EBITDA in the year to 30 September 2019 and is expected to be immediately accretive to earning

London, UK – 13 January 2020: Ergomed plc (LSE: ERGO) (“Ergomed” or the “Company”), a company focused on providing specialised services to the pharmaceutical industry, today announces the acquisition of Ashfield Pharmacovigilance Inc. (“Ashfield PV”), a specialist pharmacovigilance services provider based in Cary in the Research Triangle, North Carolina, USA (the “Acquisition”) from UDG Healthcare US Holdings, Inc., the US operating subsidiary of UDG Healthcare plc (“UDG” or the “Seller”). Ergomed has acquired the entire issued share capital of Ashfield PV for a total cash consideration of $10 million.

Dr Miroslav Reljanović, Executive Chairman of Ergomed, said: “The acquisition of Ashfield PV is a major step forward for Ergomed in the strategically important US market. It provides a significant US pharmacovigilance presence and access to a genuinely global offering for customers. It also strengthens the US platform for the Ergomed CRO business as we continue our drive towards becoming a leading mid-tier pharmaceutical services specialist with a global presence. We are enthusiastic about bringing together the specialist skills and expertise of both businesses and providing the full benefit of the combination to our clients. We look forward to welcoming the Ashfield PV team into Ergomed’s PrimeVigilance division and to working with them to grow the combined business.”

Lee Chaiken, Senior Vice President and General Manager of Ashfield PV, said: “We are delighted to join the PrimeVigilance business and to have the opportunity to work with the whole Ergomed group. With our existing strong service and loyal clients in North America, we are confident that combining with PrimeVigilance will provide a platform to grow the combined pharmacovigilance business through additional services, market-leading systems and extended coverage globally.”

Acquisition benefits

Ashfield PV is a long-established and respected provider in the pharmacovigilance services sector. It was founded as Drug Safety Alliance (DSA) in 2000 and was acquired by UDG in 2012. The company has maintained an excellent reputation as a leader amongst a small field of expert independent specialist pharmacovigilance providers in North America.

The Acquisition aligns with Ergomed’s strategy to grow its existing profitable services business both organically and through acquisition and advances a number of important strategic objectives for Ergomed:

Expanded geographic coverage for PrimeVigilance and enhanced growth. The combined business will enable coverage of North America to be offered to PrimeVigilance’s existing customers and global coverage to Ashfield PV’s existing customers. Both Ashfield PV’s and PrimeVigilance’s existing clients and potential new clients in North America are expected to find the increased global capabilities of the combined business more attractive. The Acquisition is therefore expected to further enhance the already strong growth rate in the existing PrimeVigilance business and to be revenue enhancing in the acquired client base of Ashfield PV.

Economies of scale and leverage of prior investments. PrimeVigilance’s strong history of investment in technology, infrastructure and systems has ensured that it is a market leader, offering highly effective and compliant solutions to all its clients. The Acquisition is expected to drive economies of scale, as prior investments and existing support functions are leveraged across Ergomed’s entire customer base.

Enhanced platform for broader services business. The Acquisition will support Ergomed’s drive to further develop its broader combined CRO and PV business globally, adding to the existing US presence in its CRO business and providing a platform for potential further growth in North America.
The Acquisition will be funded using the Company’s existing cash resources, without significant detriment to the Company’s ability to fund future potential acquisition opportunities. The Company is expected to continue to generate strong positive cash flow from its contracted order book, which at its interim results in September were reported to be 26.9% up on the prior year, as well as from significant recent new business wins.

Acquisition terms and Ashfield PV trading history

Under the terms of the sale and purchase agreement (the “SPA”), Ergomed has acquired the entire issued share capital of Ashfield PV for a total cash consideration of $10 million. The SPA includes customary provisions relating to normalised working capital together with warranties and indemnities to be provided by the Seller in favour of Ergomed, with any claims under these being subject to certain customary financial thresholds and caps, as well as to matters disclosed by the Seller. A transitional services agreement is in place to ensure continuity to Ashfield PV of certain services provided to it by the Seller.
In its financial year ended 30 September 2019, Ashfield PV reported revenue of $11.6 million and adjusted EBITDA of $0.9 million and had net assets of $2.8 million. The order book of contracted future revenues (“backlog”) was $9.8 million.
The acquisition is expected to be accretive to Ergomed’s 2020 earnings per share.

ENDS

Enquiries:

Ergomed plc – Tel: +44 (0) 1483 402 975
Miroslav Reljanović (Executive Chairman)
Richard Barfield (Chief Financial Officer)

Numis Securities Limited – Tel: +44 (0) 20 7260 1000
Freddie Barnfield / Huw Jeremy (Nominated Adviser)
James Black (Broker)

Consilium Strategic Communications for UK enquiries – Tel: +44 (0) 20 3709 5700 – ergomed@consilium-comms.com
Chris Gardner / Sue Stuart
Matthew Neal / Olivia Manser

MC Services – for Continental European enquiries – Tel: +49 211 5292 5222
Anne Hennecke

About Ergomed plc:

Ergomed provides specialist services to the pharmaceutical industry spanning all phases of clinical trials, post-approval pharmacovigilance and medical information. Ergomed’s fast-growing, profitable services business includes a full range of high-quality contract research and clinical trial management (CRO) services under the Ergomed brand together with an industry-leading suite of specialist pharmacovigilance (PV) solutions, integrated under the PrimeVigilance brand, and an internationally recognized specialist expertise in orphan drug development, under the PSR brand.

This seminar will take place at the Biogen Building, 8 Auditorium, Cambridge, MA.

The course will start on 2nd December at 08.00 through to 17.00 and continue on 3rd December at 09.00 through to 17.00

About the seminar:

The hype is over, and the day to day use of automation is now a reality for most. Although implementation speed and success vary significantly from company to company, excitement is growing across the board, and early successes are very encouraging.
This scientific seminar brings together leading regulators, leaders in drug safety and experts from major technology and service providers to exchange views and ideas to get ready for the near- and mid-term future of pharmacovigilance.
The first day will focus on exploration of technological and regulatory advances, and the second day will explore the impact of these changes on organizations and the pharmacovigilance system overall. It will be a joint programme with the Annual Meeting of North America’s Chapter of ISoP (NASoP), allowing leaders in PV to conveniently attend the Annual Meeting as well as the Seminar.

PrimeVigilance would like to extend its gratitude to Biogen for hosting the meeting at its premises for the third time in a row.

The faculty consists of international experts in pharmacovigilance, representing government, academia, and industry.

We encourage you to register!

To register and to see the agenda please visit : ISoP website

Please have in mind the auditorium is limited to 60 participants, to encourage interaction, networking, and exchange of invaluable insights.
For practical information, the program and registration forms are available by contacting: administration@isoponline.org

This event will be held on 21-22 November in Lisbon, Portugal

PrimeVigilance team is looking forward to attending next week’s DIA Medical Information and Communication European Annual Meeting.

This is the 13th year of the annual European Medical Information and Communications Conference. This unique meeting is organised by medical information professionals for medical information professionals. This year’s agenda includes patient communications, developing medical information content, shaping the future of medical information, automation and digital developments. This is a great opportunity for our colleagues to network, to learn and to get inspired.

If you’re attending and would like to meet Amina, please stop by our booth #3 or send us an email on marketing@primevigilance.com to set up a meeting.

For more information on the conference and the programme, please visit their website.

This event will be held in Grand Hyaat Bogota, Columbia from the 26th to the 29th of October 2019.

PrimeVigilance is looking forward to attending next week’s ISOP Bogota Annual Meeting, starting with a pre-conference course titled “Active surveillance in pharmacovigilance including pharmacoepidemiology tools“, arranged by PrimeVigilance Senior Strategic Advisor Dr. Natalia Kocankova. During this course, Dr. Kocankova will be sharing her expertise in two sessions: „Methods in active pharmacovigilance“ and „Wrap-up and Conclusions. (LATAM Conclusions, perspectives and new tools)”.

If you’re attending and would like to meet Dr. Kocankova, please stop by our booth #6 or send us an email on marketing@primevigilance.com to set up a meeting.

For more information on the conference and the programme, please visit their website.

 

This session takes place on Thursday 31st October 2019, 15:00 GMT | 16:00 CET | 11:00 EDT

As medical information is becoming global with patients accessing information from different areas, how does a company ensure that local requirements and particularities are addressed?

Alongside sharing and summarising key considerations for effective customer management when providing medical information, we will also focus on how to adapt local specificities into a global team, while ensuring that all relevant regulatory requirements are met. Examples of practical case studies will be used to illustrate the methods used to achieve the results.

In addition, Amina will be discussing:

• How to decide on the best medical information approaches for the global market
• Methodological challenges and solutions for local specificities including patient assistance programs
• Dos and Don’ts

The webinar will be followed by a Q&A session where you will be able to ask questions and receive direct feedback on key areas of uncertainty. 

Click here to book your place today. If you require further information, please do not hesitate to contact us.

 

PrimeVigilance proudly received the 2019 Queen’s Award for International Trade in recognition of its year-on-year outstanding global and innovative drug safety services to emerging and established life sciences companies.

As an International Trade winner, PrimeVigilance has demonstrated substantial growth in overseas markets and commercial success, further cementing its place as a global leader in pharmacovigilance, medical information and pharmacoepidemioloy.

This is PrimeVigilance Second Queen’s Awards for Enterprise the first one was in 2014 in recognition of substantial growth and commercial success.

We are sharing this award with all our employees and we thank them for their dedication, hard work and passion.

For more information and if you have any question please contact marketing@primevigilance.com

Dr. Imasogie’s last position was Senior Vice President, Medical Affairs, Pharmacovigilance & Medical Information of Iroko Pharmaceuticals. Dr Imasogie joins us with more than 12 years of experience in Pharmacovigilance and Medical Information management and Senior leadership.

In addition, Dr Imasogie is qualified in clinical medicine, Microsoft Certified Systems engineering, continuous medical education, public health and pharmaceutical sales.

“I am very pleased that Dr. Imasogie has decided to join our company, bringing with him his unique expertise making him a valuable asset to the company growth ” commented Dr. Jan Petracek, CEO of PrimeVigilance.

If you would like to know more about our global drug safety services and how we can help, please contact us at info@primevigilance.com