Cardiome Announces the Transfer of European Marketing Authorization from Merck

Cardiome Announces the Transfer of European Marketing Authorization from Merck

PR Newswire

VANCOUVER, June 27, 2013

NASDAQ: CRME TSX: COM

VANCOUVER, June 27, 2013 /PRNewswire/  - Cardiome Pharma Corp. (NASDAQ:  CRME) 
(TSX:  COM)  today  announced  adoption  of  the  decision  by  the  European 
Commission of the transfer  of the centrally-approved marketing  authorisation 
(MA) for BRINAVESS™ (vernakalant intravenous) from Merck Sharp & Dohme Limited
to Cardiome. The decision marks  Cardiome's assumption of responsibilities  as 
the new  marketing authorization  holder (MAH)  for BRINAVESS™  in the  member 
states of  the  European Union.  Cardiome  and  Merck will  continue  to  work 
together until September 15, 2013  to finalize the organizational  arrangement 
for transfer of all responsibilities, including batch release, and operational
management of SPECTRUM, the post-approval safety study.

"The transfer of  the European  marketing authorization to  Cardiome marks  an 
important milestone  in the  company's history,"  said William  Hunter,  M.D., 
Cardiome's president and CEO.  "Cardiome now assumes full  control of all  key 
commercialization activities for BRINAVESS™  in the European  Union and as  of 
July 1^st, will begin realizing the benefit from worldwide product revenues."

A transfer of  marketing authorization  is the procedure  by which  the MA  is 
transferred from the  currently approved marketing  authorization holder to  a 
new MAH which  is a  different person/legal entity.^1  The MAH  is allowed  to 
market  medicines  and   make  it   available  to   patients  and   healthcare 
professionals throughout the European Union when the product is registered via
the centralized procedure.

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™ (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.

References:

1.http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/q_and_a/q_and_a_detail_000045.jsp&mid=WC0b01ac0580023e80,
    accessed June 26, 2013

Forward-Looking Statement Disclaimer
Certain statements in this news 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.
Forward- looking statements may involve, but are not limited to, comments with
respect to our objectives and priorities for the remainder of 2013 and beyond,
our strategies or future actions, our targets, expectations for our financial
condition and the results of, or outlook for, our operations, research and
development and product and drug development. Such forward-looking statements
involve known and unknown risks, uncertainties and other factors that may
cause the actual results, events or developments to be materially different
from any future results, events or developments expressed or implied by such
forward-looking statements. Many such known risks, uncertainties and other
factors are taken into account as part of our assumptions underlying these
forward-looking statements and include, among others, the following: general
economic and business conditions in the United States, Canada, Europe, and the
other regions in which we operate; market demand; technological changes that
could impact our existing products or our ability to develop and commercialize
future products; competition; existing governmental legislation and
regulations and changes in, or the failure to comply with, governmental
legislation and regulations; availability of financial reimbursement coverage
from governmental and third-party payers for products and related treatments;
adverse results or unexpected delays in pre-clinical and clinical product
development processes; adverse findings related to the safety and/or efficacy
of our products or products; decisions, and the timing of decisions, made by
health regulatory agencies regarding approval of our technology and products;
the requirement for substantial funding to expand commercialization
activities; and any other factors that may affect our performance. In
addition, our business is subject to certain operating risks that may cause
any results expressed or implied by the forward-looking statements in this
presentation to differ materially from our actual results. These operating
risks include: our ability to attract and retain qualified personnel; our
ability to successfully complete pre-clinical and clinical development of our
products; changes in our business strategy or development plans; intellectual
property matters, including the unenforceability or loss of patent protection
resulting from third-party challenges to our patents; market acceptance of our
technology and products; our ability to successfully manufacture, market and
sell our products; the availability of capital to finance our activities; and
any other factors 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.

Contact:

Cardiome Investor Relations
(604) 676-6993 or Toll Free: 1-800-330-9928
Email:ir@cardiome.com
 
Press spacebar to pause and continue. Press esc to stop.