Pfizer Contributes Critical Data to URMC Drug Safety Initiative

ROCHESTER, N.Y., Jan. 12 /PRNewswire-USNewswire/ -- Pfizer Inc. has agreed to
provide the University of Rochester Medical Center (URMC) with a unique set of
electrocardiographic data that will help researchers develop new methods to
ensure the safety of experimental drugs. This is the first time a major
pharmaceutical company has agreed to publicly share anonymous data from one of
its drug safety trials, including data from the drug that was being evaluated.

Pfizer Global Research and Development's Sandwich Laboratory in the United
Kingdom is releasing a large set of continuous electrocardiographic (ECG)
recordings to URMC from which more than 1.5 million individual ECGs datasets
can be extracted.

A full set of study data, which Pfizer is providing, is extremely valuable
because it enables scientists to evaluate the electrical activity in the heart
before and after study participants took the drug and compare that data to
study subjects who received a placebo or a control drug that is known to
prolong the repolarization process.

Earlier this year, URMC announced that it was collaborating with the U.S. Food
and Drug Administration (FDA) to develop a national repository of data that
will aid academic and industry researchers studying the electrical activity of
the heart. The resulting database, called the Telemetric and Holter ECG
Warehouse (THEW), consists of a digital catalogue of continuous recordings
from both cardiac patients and healthy individuals and is available to
academic researchers, pharmaceutical companies, contract research
organizations, device manufacturers, and other interested parties.

The Pfizer data, in compliance with international privacy laws, has been fully
anonymized, or stripped of any information that would enable individual
patients to be identified. Additionally, the THEW was designed in order to
comply with ethics and patient privacy laws; all data in the warehouse have
been de-identified and the system is fully compliant with federal privacy
(HIPPA) regulations.

"We are glad and thankful that Pfizer has chosen the THEW platform for sharing
their data with the international scientific community," said Jean-Philippe
Couderc, Ph.D., director of the THEW initiative. "We believe the global
strategy of our initiative, its legal framework, and the support received from
the Food and Drug Administration have played key roles in the development of
successful collaboration with companies like Pfizer."

The Pfizer data will be housed in THEW and will enable researchers to develop
new tools to detect drugs that may have dangerous effects on the heart. The
Pfizer data will consist of several important sets of ECGs from different
phases of a study of a drug that did not reach the market because of its
adverse effect of the process of cardiac ventricular repolarization - the
split-second period between the heart's contraction and recovery phase. If a
drug prolongs the repolarization process, then it is generally believed to
heighten the risk for adverse cardiac events, such as dangerous arrhythmias
and heart attacks.

Sudden cardiac arrest is the leading cause of death in the United States,
resulting in more than 450,000 deaths per year. Included in this number are
deaths caused by drugs that trigger a predisposition to lethal cardiac
arrhythmias or even the drugs themselves. As part of FDA's regulatory review
process, the agency requires evidence of a drug's impact on the QT interval as
one way to assess the cardiac risk associated with new compounds. The QT
interval is a segment of an ECG recording that measures the process of
ventricular repolarization. Prolongation of the QT interval associated with
episodes of fatal ventricular arrhythmias is a leading cause of removal of
drugs from the market and was a leading impetus toward international
collaboration to develop specialized studies to monitor the QT prolongation
effects of new drugs. The THEW project is part of this initiative.

The THEW database is a component of URMC's Heart Research Follow-up Program.
The Program is an international leader in the science of heart arrhythmias and
a rare genetic condition associated with an abnormal QT interval, called the
congenital Long QT Syndrome (LQTS). URMC keeps an International Registry for
LQTS, and follows thousands of families who have this inherited condition. One
of the genetic forms of the QT prolongation syndrome is similar to the
drug-induced syndrome, and the University's work focuses on developing the
tools to identify individuals with either condition.

THEW website: http://www.thew-project.org/

About the University of Rochester Medical Center
One of the nation's top academic medical centers, the University of Rochester
Medical Center (http://www.urmc.rochester.edu) forms the centerpiece of the
University's health research, teaching, patient care, and community outreach
missions. The Medical Center receives more than $230 million in external
research funding per year and the University of Rochester School of Medicine
and Dentistry ranks in the top one-quarter of U.S. medical centers in federal
research funding. The University's health care delivery network is anchored by
Strong Memorial Hospital - a 739-bed, University-owned teaching hospital. As
upstate New York's premier health care delivery network, patients benefit from
the Medical Center's robust teaching and biomedical research programs.

SOURCE University of Rochester Medical Center

Mark Michaud of University of Rochester Medical Center, +1-585-273-4790,
Mark_michaud@urmc.rochester.edu