Cardiome Announces Positive Interim Phase 2b Results for Oral Vernakalant and Engages Merrill Lynch as Strategic Advisor

    TSX: COM

    VANCOUVER, March 17 /CNW/ - Cardiome Pharma Corp. (NASDAQ:   CRME/TSX: COM)
today announced positive interim clinical results from its 90-day Phase 2b
study of vernakalant (oral). The interim analysis demonstrated statistically
significant efficacy for the patient group receiving 500mg b.i.d. of
vernakalant (oral) as compared to placebo. The safety data from the interim
analysis also suggests that vernakalant (oral) was well-tolerated in the
atrial fibrillation population studied during the dosing period under
    A Kaplan-Meier analysis of the 446 patients included in the interim
dataset demonstrated a significant efficacy benefit for the 500mg dosing group
as compared to placebo (two-sided, p(less than)0.05). Median time to
recurrence of atrial fibrillation was greater than 90 days for the 500mg
dosing group, compared to 39 days for the placebo group. 52% of patients in
the 500mg dosing group (n=110) completed the study in normal heart rhythm
compared to 39% of patients receiving placebo (n=118). The interim efficacy
analysis for the 150mg (n=110) and 300mg (n=108) dosing groups had
not achieved statistical significance at the interim timepoint.
    "This larger-scale, longer-term study of vernakalant (oral) was designed
to find the appropriate dose to take into Phase 3, and to confirm our
assumptions regarding safety," said Dr. Charles Fisher, Executive Vice
President and Chief Medical Officer of Cardiome. "While the study is ongoing
and we must await the final data before drawing conclusions, these
statistically significant and clinically significant efficacy results as well
as the attractive safety profile observed in this interim analysis strongly
support our belief in the exciting potential of vernakalant (oral) as a
therapy for atrial fibrillation."
    The safety data for all dosing groups suggests that vernakalant (oral)
was well-tolerated within the interim safety population (n=537), which
includes patients randomized who did not enter the maintenance phase of the
study. During the dosing period under analysis, there was no difference in the
incidence of serious adverse events between treatment groups. Potentially
drug-related serious adverse events occurred in 1% of placebo patients, 2% of
patients in the 150mg dosing group, 0% of patients in the 300mg dosing group
and 1% of patients in the 500mg dosing group. There were no cases of
drug-related "Torsades de Pointes", a well-characterized arrhythmia which is
an occasional side effect of some current anti-arrhythmic drugs. There were 2
deaths during this period, both unrelated to vernakalant (oral), comprising a
patient in the 150mg dosing group who died of cervical cancer at day 79, and a
patient in the placebo group who died at day 86 after suffering an ischemic
    "Our strategic intent with this study was to pave the way to Phase 3 and
provide efficacy and safety data to support business discussions," said Bob
Rieder, Chairman and Chief Executive Officer of Cardiome. "This strong interim
data set clearly enables us to move forward in planning the Phase 3 program
and continue our discussions with interested parties."
    The double-blind, placebo-controlled, randomized, dose-ranging study was
designed to explore safety and tolerability, pharmacokinetics and efficacy of
vernakalant (oral) over 90 days of dosing in patients at risk of recurrent
atrial fibrillation. Patients received a 150mg, 300mg or 500mg dose of
vernakalant (oral) or placebo twice per day. After the first 3 days, patients
still in atrial fibrillation were electrically cardioverted. Successfully
cardioverted patients continued to receive vernakalant (oral) or placebo for
the remainder of the 90-day trial and were monitored throughout the dosing
    Cardiome initiated the Phase 2b in the first quarter of 2007. Enrollment
has completed, with a total of 735 patients randomized of which approximately
590 patients are expected to enter the maintenance phase and be measured for
efficacy. Final results from the study are expected in the third quarter of
    Cardiome also announced that it has received detailed expressions of
interest from global and regional pharmaceutical companies in pursuit of
partnership opportunities for vernakalant. Cardiome's Board of Directors has
engaged Merrill Lynch & Co. as its financial advisor to assist in evaluating
these partnership opportunities as well as alternative strategies beyond
partnerships to maximize shareholder value, including acquisitions,
divestitures and the sale of all or part of the Company.
    "We began a partnership cycle in the second half of 2007 in anticipation
of the U.S. approval of vernakalant (iv) and results from the vernakalant
(oral) Phase 2b trial," said Doug Janzen, President and Chief Business Officer
of Cardiome. "In light of today's positive results, we look forward to
furthering our partnership discussions with those companies who have expressed
interest to date, and welcome Merrill Lynch's assistance in ensuring
shareholder value is maximized. Obviously, there can be no assurance that
Cardiome's review of partnership opportunities and other strategic
alternatives will result in any specific transaction, and while this review is
about to be initiated, no timetable has been set for its completion."
    Cardiome will hold a teleconference and webcast on Monday, March 17, 2008
at 9:00am Eastern (6:00am Pacific). To access the conference call, please dial
416-340-8010 or 866-540-8136. There will be a separate dial-in line for
analysts on which we will respond to questions at the end of the call. The
webcast can be accessed through Cardiome's website at
    Webcast and telephone replays of the conference call will be available
approximately two hours after the completion of the call through April 17,
2008. Please dial 416-695-5800 or 800-408-3053 and enter code 3255778 followed
by the number sign to access the replay.

    About Cardiome Pharma Corp.

    Cardiome Pharma Corp. is a product-focused cardiovascular drug
development company with two late-stage clinical drug programs focused on
atrial arrhythmia (intravenous and oral dosing), a Phase 1 program for
GED-aPC, an engineered analog of recombinant human activated Protein C, and a
pre-clinical program directed at improving cardiovascular function.
    Vernakalant (iv) is the intravenous formulation of an investigational
drug being evaluated for the acute conversion of atrial fibrillation. Positive
top-line results from two pivotal Phase 3 trials for vernakalant (iv), called
ACT 1 and ACT 3, were released in December 2004 and September 2005. Cardiome's
co-development partner Astellas Pharma US, Inc. submitted a New Drug
Application for vernakalant (iv) in December 2006. Positive top-line results
from an additional Phase 3 study evaluating patients with post-operative
atrial arrhythmia, called ACT 2, were released in June 2007. An open-label
safety study evaluating recent-onset AF patients, called ACT 4, has completed.
    Vernakalant (oral) is being investigated as a chronic-use oral drug for
the maintenance of normal heart rhythm following termination of AF. Cardiome
announced positive results from a Phase 2a pilot study for vernakalant (oral)
in September 2006. A Phase 2b study for vernakalant (oral) is ongoing.
    In April 2007 Cardiome acquired exclusive worldwide rights for GED-aPC
for all indications. Cardiome intends to initially develop GED-aPC in
cardiogenic shock, a life-threatening form of acute circulatory failure due to
cardiac dysfunction, which is a leading cause of death for patients
hospitalized following a heart attack.
    Cardiome is traded on the Toronto Stock Exchange (COM) and the NASDAQ
National Market (CRME).

    Forward-Looking Statement Disclaimer

    Certain statements in this press release contain forward-looking
statements within the meaning of the Private Securities Litigation Reform Act
of 1995 or forward-looking information under applicable Canadian securities
legislation that may not be based on historical fact, including without
limitation statements containing the words "believe", "may", "plan", "will",
"estimate", "continue", "anticipate", "intend", "expect" and similar
expressions. Such forward-looking statements or information involve known and
unknown risks, uncertainties and other factors that may cause our actual
results, events or developments, or industry results, to be materially
different from any future results, events or developments expressed or implied
by such forward-looking statements or information. Such factors include, among
others, our stage of development, lack of product revenues, additional capital
requirements, risk associated with the completion of clinical trials and
obtaining regulatory approval to market our products, the ability to protect
our intellectual property, dependence on collaborative partners and the
prospects for negotiating additional corporate collaborations or licensing
arrangements and their timing. Specifically, certain risks and uncertainties
that could cause such actual events or results expressed or implied by such
forward-looking statements and information to differ materially from any
future events or results expressed or implied by such statements and
information include, but are not limited to, the risks and uncertainties that:
we may not be able to successfully develop and obtain regulatory approval for
vernakalant (iv) or vernakalant (oral) in the treatment of atrial fibrillation
or any other current or future products in our targeted indications; our
future operating results are uncertain and likely to fluctuate; we may not be
able to raise additional capital; we may not be successful in establishing
additional corporate collaborations or licensing arrangements; we may not be
able to establish marketing and sales capabilities and the costs of launching
our products may be greater than anticipated; we rely on third parties for the
continued supply and manufacture of vernakalant (iv) and vernakalant (oral)
and we have no experience in commercial manufacturing; we may face unknown
risks related to intellectual property matters; we face increased competition
from pharmaceutical and biotechnology companies; and other factors as
described in detail in our filings with the Securities and Exchange Commission
available at and the Canadian securities regulatory authorities at Given these risks and uncertainties, you are cautioned not to
place undue reliance on such forward-looking statements and information, which
are qualified in their entirety by this cautionary statement. All
forward-looking statements and information made herein are based on our
current expectations and we undertake no obligation to revise or update such
forward-looking statements and information to reflect subsequent events or
circumstances, except as required by law.

For further information:

For further information: Peter K. Hofman, Senior Director, Investor
Relations, (604) 676-6993 or Toll Free: 1-800-330-9928, Email:

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