NASDAQ: CRME TSX: COM
VANCOUVER, April 30 /CNW/ - Cardiome Pharma Corp. (NASDAQ: CRME / TSX:
COM) today announced that it has signed an exclusive in-licensing agreement
with Eli Lilly and Company ("Lilly") for LY458202 ("GED-aPC"), a
clinical-stage drug candidate, whereby Cardiome has been granted exclusive
worldwide rights to GED-aPC for all indications.
GED-aPC is an engineered analog of recombinant human activated Protein C
(aPC) with enhanced anti-inflammatory, anti-thrombotic and strong binding to
endothelial protein C receptor properties, and has broad potential across
multiple 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.
"The scientific community is increasingly recognizing the role of
inflammation in cardiovascular disease, and we have been searching for a drug
candidate with the capacity to address cardiovascular disease through
anti-inflammatory and anti-thrombotic mechanisms," said Dr. Charles Fisher,
Executive Vice President and Chief Medical Officer of Cardiome. "GED-aPC is a
pluripotent molecule with multiple mechanisms of action targeting key
counter-regulatory pathways, and we believe that these engineered
characteristics make it a highly desirable drug candidate for cardiovascular
Lilly has successfully completed a 46-person Phase 1 single-dose
placebo-controlled safety study in healthy volunteers for GED-aPC. Cardiome
intends to meet with the FDA in the near future regarding plans to conduct
multi-dose Phase 1 studies commencing in the second half of 2007. Pending
successful completion of these studies, Cardiome intends to initiate one or
more Phase 2 studies in the first half of 2008.
Under terms of the agreement, Lilly will also provide Cardiome with
access to intellectual property related to manufacturing of GED-aPC, and
facilitate access to clinical and commercial production capacity at an
established third party manufacturing facility for a defined period of time.
Included in the transaction is an initial supply of GED-aPC, which is expected
to be sufficient for completion of the contemplated Phase 1 program.
Financial terms of the agreement include an upfront payment of
US$20 million payable to Lilly and development milestones not to exceed
US$40 million contingent on achievement of certain pre-defined late-stage
clinical milestones. Lilly will also be entitled to royalty payments if the
molecule is ultimately commercialized. Cardiome estimates that clinical
expenditures on the GED-aPC program will be approximately US$5 million in
"We believe strongly that the unique profile of this drug will be
effective in treating several forms of cardiovascular disease," stated Bob
Rieder, Chairman and Chief Executive Officer of Cardiome. "Success in our
industry arises from bringing benefit to patients. This drug, with its
excellent mechanistic and clinical pedigree, offers great promise to patients
suffering from various forms of cardiovascular disease for which few effective
treatments are available."
Cardiome will hold a teleconference and webcast on Monday, April 30, 2007
at 1:00pm ET (10:00am PT) to discuss the transaction. Please dial 800-814-4859
or 416-644-3433 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 May 30, 2007.
Please dial 877-289-8525 or 416-640-1917, and enter code 21231012 followed by
the number sign to access the replay.
About Cardiogenic Shock (CS)
Cardiogenic shock is a state of inadequate bloodflow to the body's tissue
caused by the failure of the heart to pump effectively, most commonly
following acute myocardial infarction (heart attack). In 2006, more than
870,000 people suffered a heart attack in the U.S., with approximately 6% of
them developing cardiogenic shock. Mortality rates for patients with
cardiogenic shock remain high, ranging from 40% to 70%. There are currently no
approved drugs to treat this indication.
About Cardiome Pharma Corp.
Cardiome Pharma Corp. is a product-focused cardiovascular drug
development company with two clinical drug programs focused on atrial
arrhythmia (intravenous and oral dosing), 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. An additional Phase 3 study evaluating patients with post-operative
atrial arrhythmia, called ACT 2, and an open-label safety study evaluating
recent-onset AF patients, called ACT 4, are ongoing. Cardiome's co-development
partner Astellas Pharma US, Inc. submitted a New Drug Application for
vernakalant (iv) in December 2006.
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,
an engineered analog of recombinant human activated Protein C (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 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: