• Dublin, Ireland

ICON and Pfizer win for excellence in study start-up and patient recruitment in cardiovascular outcome studies

ICON plc, (NASDAQ: ICLR) a global provider of drug development solutions and services to the pharmaceutical, biotechnology and medical device industries, today announced that, together with Pfizer, it has won the Clinical Research Team of the Year award at the inaugural Clinical and Research Excellence (CARE) Awards which took place in Boston on the 27th April.

The award honoured the achievements of the team that has made the most difference to a pharmaceutical or biotechnology company’s research program, and has made great strides on its core project through exemplary team-working.

ICON and Pfizer won the award for their achievements in 2015 on two ongoing parallel cardiovascular outcome studies, which will involve approximately 26,000 patients at 3,000 sites in 35 countries. Through close collaboration and by adopting a single team approach, ICON and Pfizer designed a framework that re-engineered the site start-up process and enabled them to meet or exceed the studies’ site activation and patient enrolment targets for 2015.

Pfizer has created SPIRE (Studies of PCSK9 Inhibition and the Reduction of vascular Events), an extensive research program to study bococizumab, its investigational Proprotein Convertase Subtilisin Kexin type 9 inhibitor (PCSK9i). The SPIRE Phase 3 global clinical development program consists of six lipid-lowering studies (SPIRE-SI, SPIRE-AI, SPIRE-HR, SPIRE-FH, SPIRE-LL and SPIRE-LDL) as well as two cardiovascular outcome studies (SPIRE-1 and SPIRE-2).

The two cardiovascular outcome studies are investigating the ability of bococizumab to reduce the risk of cardiovascular events in a broad range of high-risk primary and secondary prevention patients, including those with diabetes, chronic kidney disease, peripheral vascular disease or familial hypercholesterolemia, in addition to those with previous cardiovascular events such as heart attack, stroke, or cardiovascular revascularisation procedures.

Commenting on the award, ICON’s Chief Executive, Ciaran Murray, said: “We are proud that the expertise of our clinical research teams and our partnership approach with clients have been recognised as the industry’s best. Site activation and patient recruitment are two of the most challenging aspects of managing clinical studies and it was particularly pleasing that all timelines in these studies were either met or exceeded, thanks to the hard work of the combined Pfizer and ICON team. Building strong teams that have the knowledge and experience to act as trusted partners to our clients is a key focus at ICON and I’m delighted that one of our teams has been honoured by the industry.”

Commenting on the award, Pfizer’s Vice President for Clinical Operations, Bill Erhardt said “The SPIRE program for bococizumab is the only PCSK9i research program assessing cardiovascular outcomes in a broad range of high-risk primary and secondary prevention patients. It is only through a close partnership, innovative problem solving and teamwork that landmark trials of this magnitude can be completed efficiently in order to completely characterize this important potential new medicine. Pfizer is very pleased that this team has been recognized with the CARE award.”

Bococizumab is an investigational compound and has not received regulatory approval in any country.

The inaugural CARE Awards celebrate the outstanding clinical research achievements from 2015. The awards showcase excellence in clinical trial design, technological advancements within the industry, outstanding research results, as well as achievements of individuals, departments, teams, or organisations.

Award winners have contributed to the advancement of therapies for unmet medical needs, undertaken ground-breaking collaborations, and contributed to positive clinical outcomes while demonstrating best practices and innovation. More detail on the CARE awards and the 2016 winners is at https://ibiawards.com/careawards/.

About ICON plc

ICON plc is a global provider of drug development solutions and services to the pharmaceutical, biotechnology and medical device industries. The company specialises in the strategic development, management and analysis of programs that support clinical development - from compound selection to Phase I-IV clinical studies. With headquarters in Dublin, Ireland, ICON currently, operates from 97 locations in 38 countries and has approximately 13,380 employees.

ICON Media Contact

Camille Frederix
Weber Shandwick
+44 (0) 207 067 0272

This press release contains forward-looking statements. These statements are based on management's current expectations and information currently available, including current economic and industry conditions. These statements are not guarantees of future performance or actual results, and actual results, developments and business decisions may differ from those stated in this press release. The forward-looking statements are subject to future events, risks, uncertainties and other factors that could cause actual results to differ materially from those projected in the statements, including, but not limited to, the ability to enter into new contracts, maintain client relationships, manage the opening of new offices and offering of new services, the integration of new business mergers and acquisitions, as well as economic and global market conditions and other risks and uncertainties detailed from time to time in SEC reports filed by ICON, all of which are difficult to predict and some of which are beyond our control. For these reasons, you should not place undue reliance on these forward-looking statements when making investment decisions. The word "expected" and variations of such words and similar expressions are intended to identify forward-looking statements. Forward-looking statements are only as of the date they are made and we do not undertake any obligation to update publicly any forward-looking statement, either as a result of new information, future events or otherwise. More information about the risks and uncertainties relating to these forward-looking statements may be found in SEC reports filed by ICON, including its Form 20-F, F-1, S-8 and F-3, which are available on the SEC's website at http://www.sec.gov.