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ICON Selected by the FDA to Validate Patient-Reported Outcome Endpoints for Antibacterial Drug Trials


, (NASDAQ: ICLR) a global provider of drug development
solutions and services to the pharmaceutical, biotechnology and medical
device industries, today announced that it has been awarded a project by
the US
Food & Drug Administration
 (FDA) to validate three Patient
Reported Outcomes (PRO) instruments that will measure clinical endpoints
in antibacterial drug trials. The conditions in which the endpoints will
be validated are Acute Bacterial Skin and Skin Structure Infections
(ABSSSI), Community-Acquired Bacterial Pneumonia (CABP) and
Hospital-Acquired Bacterial Pneumonia (HABP).

HABP is the second most common hospital-acquired infection and is the
primary cause of death in intensive care units; ABSSSI has high rates of
morbidity and other associated medical conditions whilst CABP is a major
cause of mortality and morbidity worldwide, particularly among people
over 65 years of age. Sponsors engaged in clinical trials for these
conditions are currently using different methodologies to assess the
primary endpoint as there is no qualified PRO instrument.

ICON's Clinical Outcomes Assessment (COA) group, in collaboration with
the Biomarkers
of the Foundation
for the National Institutes of Health 
(FNIH), will create an
electronic platform to validate key PROs, allowing investigators to
assess the symptoms of ABSSSI, CABP and HABP at various time points over
the course of the infection and measure the effects of antibacterial
drugs. The PROs will be implemented on CRF Health's TrialMax® eCOA
platform, allowing patients to use the application on a handheld device
during the course of the trials. These PROs will continue to be
validated and developed in accordance with the FDA guidance for PRO
measures used to support labeling claims and will follow the Drug
Development Tool (DDT) Qualification Program.

The collaboration brings together scientists from ICON, FNIH, the FDA,
the National
Institute of Allergy and Infectious Diseases
, the Infectious
Diseases Society of America
, pharmaceutical and biotechnology
companies and the academic research community, to develop new approaches
for evaluating the efficacy of antibiotics in future clinical trials of
therapies for ABSSSI, CABP and HABP.

"This project builds on our previous work with the FDA and FNIH to
develop a new PRO measure for HABP trials and we're proud to continue
our support in this area of great unmet need,"
commented Ramita
Tandon, Executive Vice President, ICON Commercialisation & Outcomes. "Bacterial
infections are becoming harder to treat as drug-resistant strains emerge
at an increasing rate. ICON's COA group has extensive experience in all
areas of outcomes research to validate these important endpoints for
antibacterial trials, speeding up the drug development process and
delivering effective antibacterial medicines to patients."

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 87 locations in 38 countries and
has approximately 12,500 employees. Further information is available at

About the FNIH

The Foundation for the National Institutes of Health creates and manages
alliances with public and private institutions in support of the mission
of the NIH, the world's premier medical research agency. The Foundation,
also known as the FNIH, works with its partners to accelerate key issues
of scientific study and strategies against diseases and health concerns
in the United States and across the globe. The FNIH organizes and
administers research projects; supports education and training of new
researchers; organizes educational events and symposia; and administers
a series of funds supporting a wide range of health issues. Established
by Congress in 1996, the FNIH is a not-for-profit 501(c)(3) charitable
organization. Further information is available at

About the Biomarkers Consortium

The Biomarkers Consortium is a public-private biomedical research
partnership managed by the Foundation for the National Institutes of
Health (FNIH) that endeavors to develop, validate, and/or qualify
biological markers (biomarkers) to speed the development of medicines
and therapies for detection, prevention, diagnosis and treatment of
disease and improve patient care.

Further information is available at

About CRF Health

CRF Health is the leading provider of patient-centered eSource
technology and service solutions for the life sciences industry. With
experience in more than 800 trials, over 100 languages and across 74
countries, CRF Health's TrialMax® platform consistently demonstrates the
industry's highest data accuracy, patient and site compliance, and
patient retention.

CRF Health's eSource solutions improve trial engagement by fitting into
the lives of patients and seamlessly integrating into sites to maximize
protocol compliance. The integrated TrialMax® platform includes eCOA
solutions for collecting PROs (Patient Reported Outcomes), ObsROs
(Observer Reported Outcomes), ClinROs (Clinician or Rater Reported
Outcomes), and PerfOs (Performance Outcomes), and features
TrialConsent™, an electronic solution for collecting informed consent in
clinical trials. More information is at

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


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