Last updated on April 23, 2014 at 21:24 EDT

Cardiome Selects Quintiles To Manage Global Regulatory Affairs And Life Cycle Safety Activities For BRINAVESS(TM) (Vernakalant Intravenous)

February 4, 2013


VANCOUVER, Feb. 4, 2013 /PRNewswire/ – Cardiome Pharma Corp. (NASDAQ: CRME /
TSX: COM) today announced the selection of Quintiles to provide
comprehensive post-marketing lifecycle safety and global regulatory
affairs services for BRINAVESS(TM). Quintiles, the world’s leading
provider of biopharmaceutical services, will begin providing these
services effective immediately as Cardiome continues to prepare for the
anticipated transfer of BRINAVESS(TM) from Merck to Cardiome.

“We are very pleased to begin our partnership with Quintiles during the
pending return of global rights for the intravenous (IV) and oral
formulations of vernakalant to Cardiome,” stated William Hunter, M.D.,
interim CEO of Cardiome. “Finding a highly capable service provider to
deliver operational regulatory and pharmacovigilance support was a key
priority to effectively and expeditiously transfer the registered
marketing authorizations from Merck to Cardiome.  We believe that
Quintiles’ global reach and extensive expertise in these areas will
help facilitate a seamless worldwide transition.”

In September 2012, Merck informed Cardiome that Merck (through two of
its subsidiaries) would return the global marketing and development
rights for both the intravenous and oral formulations of vernakalant to
Cardiome. Vernakalant IV is marketed under the brand name BRINAVESS(TM). BRINAVESS(TM) has received approval in the European Union and certain other markets
worldwide for the rapid conversion of recent onset atrial fibrillation
(AF) to sinus rhythm in adults: for non-surgery patients with AF of
seven days or less and for post-cardiac surgery patients with AF of
three days or less. Vernakalant IV is not approved for use in the
United States or Canada.

About Cardiome Pharma Corp. Cardiome Pharma Corp. is a biopharmaceutical company dedicated to the
discovery, development and commercialization of new therapies that will
improve the health of patients around the world. Cardiome has one
marketed product, BRINAVESS(TM) (vernakalant IV), approved in Europe and
other territories for the rapid conversion of recent onset atrial
fibrillation to sinus rhythm in adults.

Cardiome is traded on the NASDAQ Capital Market (CRME) and the Toronto
Stock Exchange (COM). For more information, please visit our web site
at www.cardiome.com.

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. Risks, uncertainties
and factors 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, uncertainties and factors related to the fact that: we, together
with our collaborative partner, may not be able to successfully develop
all or any of our current or future products and may not be able
to obtain regulatory approval in targeted indications for our current
or future products in all markets; we may not achieve or maintain
profitability; our future operating results are uncertain and likely to
fluctuate; we may not be able to raise additional capital as and when
required; we depend on our collaborative partner to perform their
obligations under licensing or other collaborative agreements; 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; any of our products that obtain regulatory
approval will be subject to extensive post-market regulation that may
affect sales, marketing and profitability; any of our products that are
successfully developed may not achieve market acceptance; we rely on
third parties for the continued supply and manufacture of our products
and have no experience in commercial manufacturing; we may face unknown
risks related to intellectual property matters, including with respect
to our ability to protect our intellectual property; 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, uncertainties and factors, 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.

SOURCE Cardiome Pharma Corp.

Source: PR Newswire