VANCOUVER and DEERFIELD, IL, June 4 /CNW/ - Cardiome Pharma Corp.
(NASDAQ: CRME / TSX: COM) and its co-development partner Astellas Pharma US,
Inc. ("Astellas") today announced results from their recently completed
Phase 3 clinical study, called ACT 2. The trial evaluated the efficacy and
safety of the intravenous formulation of vernakalant hydrochloride
("vernakalant (iv)") for the treatment of patients who developed atrial
fibrillation or atrial flutter between 24 hours and 7 days following coronary
artery bypass graft (CABG) or valve replacement surgery. In the atrial
fibrillation population, 47% of patients dosed with vernakalant (iv)
experienced conversion to normal heart rhythm within 90 minutes, as compared
to 14% of placebo patients, a statistically significant difference (p=0.0001).
The ACT 2 study data suggests that vernakalant (iv) was well-tolerated in
the studied patient population. In the 30-day interval following drug
administration, serious adverse events occurred in 9% of all patients dosed
with vernakalant (iv) and 11% of all placebo patients. Potentially
drug-related serious adverse events occurred in 2% of patients who received
vernakalant (iv) and 0% of placebo patients. There were no cases of
drug-related "Torsades de Pointes", a specific and well-characterized
The study achieved its primary endpoint in the combined atrial
fibrillation and atrial flutter groups, showing that 45% of patients receiving
vernakalant (iv) converted to normal heart rhythm within 90 minutes, as
compared to 15% of placebo patients within the same time period (p=0.0002).
Of the 10 patients in the atrial flutter population, no patients in the drug
group and one patient in the placebo group converted to normal heart rhythm. A
total of 190 patients were randomized in the study, of which 161 received
In the patients treated with vernakalant (iv) who converted to normal
heart rhythm within 90 minutes, the median time to conversion was 12 minutes
from the initiation of dosing.
"We are delighted to see a 47% conversion rate in post-operative atrial
fibrillation patients, and in particular we are encouraged by the safety
profile observed in this fragile patient population," stated Bob Rieder, Chief
Executive Officer and Chairman of Cardiome. "The efficacy and safety results
observed in this study are consistent with those we've seen throughout the
vernakalant (iv) development program."
The ACT 2 study was conducted in 42 centres in the United States, Canada,
Argentina, India and Europe. The study was focused on the treatment of
patients with atrial fibrillation or atrial flutter occurring after CABG or
valve replacement surgery. Approximately 30% of these patients have an episode
of atrial arrhythmia following their surgery. The arrhythmia, though
transient, is a significant medical concern.
"We are very pleased with the results of the ACT 2 trial and the
important insight it provides about the use of vernakalant (iv)," stated
Yoshihiko Hatanaka, President and Chief Executive Officer of Astellas Pharma
In October 2003, Cardiome granted Astellas Pharma US, Inc. an exclusive
license to develop and commercialize vernakalant (iv) in North America. The
companies have co-developed vernakalant (iv) to NDA, with Astellas responsible
for 75% of development costs. Cardiome has retained all rights to the
intravenous formulations outside of Canada, U.S. and Mexico.
Cardiome will hold a conference call and webcast on Monday, June 4, 2007
at 9:00am EDT (6:00am PDT). Please dial 416-340-8010 or 866-540-8136 to access
the call. There will be a separate dial-in line for analysts on which we will
respond to questions at the end of the presentation. The webcast can be
accessed through Cardiome's website at www.cardiome.com. Webcast and telephone
replays of the conference call will be available approximately two hours after
the completion of the call through July 4, 2007. Please dial 416-695-5800 or
800-408-3053 and enter code 3225539 followed by the number sign to access the
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 (AF).
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, is ongoing.
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).
About Astellas Pharma US, Inc.
Astellas Pharma US, Inc., located in Deerfield, Illinois, is a US
affiliate of Tokyo-based Astellas Pharma Inc. Astellas is a pharmaceutical
company dedicated to improving the health of people around the world through
the provision of innovative and reliable pharmaceutical products. The
organization is committed to becoming a global pharmaceutical company by
combining outstanding R&D and marketing capabilities and continuing to grow in
the world pharmaceutical market. For more information about Astellas Pharma
US, Inc., please visit our website at www.astellas.com/us.
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 www.sec.gov and the Canadian securities regulatory authorities at
www.sedar.com. 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:
email@example.com; Maribeth Landwehr, Assistant Director, Corporate
Communications, Astellas Pharma US, Inc., (847) 317-8988