New Analysis Suggests Early Initiation of Multaq(R) (dronedarone) Feasible in AF Patients Following Discontinuation of Amiodarone

WYNNEWOOD, Pennsylvania, March 15, 2010 - Data from a post-hoc analysis presented today at the 59th
Annual Scientific Session of the American College of Cardiology in Atlanta,
Georgia, evaluated transition to Multaq(R) (dronedarone) in patients with
atrial fibrillation (AF) or atrial flutter (AFL) following prior treatment
with amiodarone. The data comes from a post-hoc analysis of pooled data from
the EURIDIS and ADONIS sinus rhythm maintenance trials and assessed the
impact of initiation of dronedarone therapy on safety and efficacy within two
days after stopping amiodarone.

The analysis included 223 patients previously treated with
amiodarone, in which Multaq (dronedarone) or placebo was initiated in a
subgroup of 154 patients (Multaq = 98, placebo = 56) within two days of
discontinuing amiodarone. The subgroup represents 18 percent of the patients
enrolled in the EURIDIS and ADONIS studies (7.9% treated with Multaq) and was
compared with a group of patients who had no prior treatment with amiodarone
(n=1014). Groups were compared on the primary study endpoint, time to first
recurrence of AF/AFL as well as incidence of adverse events.

In this subgroup, Multaq (dronedarone) decreased AF/AFL
recurrence compared to placebo (HR=0.64 [95% CI 0.44-0.95], P=0.022) which is
consistent with the overall study results in which dronedarone decreased the
rate of AF recurrence by HR=0.75 [95% CI 0.65-0.87], P=0.001. The rate of
serious adverse events was low and similar across groups with no episodes of
torsades de pointes reported. There were more bradyarrhythmic events in
patients treated with dronedarone (3.1%) compared to placebo (0%) and drug
discontinuation due to QTc-prolongations (dronedarone = 7.9% versus placebo =
3.6% with QTc greater than or equal to 500 msec) in the patients previously
treated with amiodarone, as expected from the pharmacodynamic profile of
the drugs.[1]

"The data presented today suggest it may be possible to initiate Multaq
following discontinuation of amiodarone in paroxysmal and persistent patients
within two days, while maintaining efficacy at preventing AF recurrence.
Caution should be given to heart rate and QTc intervals prior to
consideration of early initiation of dronedarone," said Peter Kowey, M.D.,
FACC, Chief of the Division of Cardiovascular Diseases at the Main Line
Health System, Wynnewood, Pennsylvania. "These results are hypothesis
generating and indicate that a prospective trial is warranted, which is
currently being put in place, sponsored by the manufacturers."

In the U.S., Multaq is indicated to reduce the risk of
cardiovascular hospitalization in patients with paroxysmal or persistent
atrial fibrillation (AF) or atrial flutter (AFL), with a recent episode of
AF/AFL and associated cardiovascular risk factors (i.e., age >70,
hypertension, diabetes, prior cerebrovascular accident, left atrial diameter
greater than or equal to 50 mm or left ventricular ejection fraction
[LVEF] <40%), who are in sinus rhythm or who will be cardioverted.[2]

About Main Line Health

Main Line Health (www.mainlinehealth.org) (MLH) is a non-profit
health system serving portions of Philadelphia and its western suburbs. The
mission of Main Line Health is to provide a comprehensive range of safe,
high-quality health services, complemented by related education and research
activities that meet the healthcare needs and improve the quality of life in
the communities we serve.

Founded in 1985, MLH includes Bryn Mawr Hospital, Lankenau Hospital,
Paoli Hospital, Riddle Memorial Hospital, Bryn Mawr Rehabilitation Hospital;
The Home Care Network; Lankenau Institute for Medical Research; Main Line
HealthCare (physician network); Main Line Health Centers; Main Line Health
Laboratories; Mid County Senior Services; and Mirmont Treatment Center. Main
Line Health is part of Jefferson Health System (JHS), founded in 1996, whose
members also include Thomas Jefferson University Hospitals and Magee Rehab.

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    [1] Kowey, P. "Impact of Dronedarone Started Rapidly After Amiodarone
        Discontinuation" abstract. ACC 2010.
    [2] Multaq(R) U.S. Prescribing information www.multaq.com

MEDIA CONTACT: Bridget Therriault, Manager of Communications, Office: +1-484-337-8763, Cell: +1-484-222-9154, therriaultb at mlhs.org