NASDAQ: CRME TSX: COM
VANCOUVER, Nov. 29, 2016 /CNW/ - Cardiome Pharma Corp.
(NASDAQ: CRME / TSX: COM) is pleased to announce that it has moved
one step closer to launching XYDALBA in the UK by receiving an
established price from the Secretary of State for Health, under
regulation 3 of the Health Service Branded Medicines
Regulations.
Commenting on the development, Hugues Sachot, Senior Vice
President Commercial at Cardiome said, "We are extremely pleased
with the progress that XYDALBA continues to make toward our
imminent launch in the UK and other European countries we have
under license from Allergan plc. The creation of an established
price does not guarantee reimbursement in the UK, but it is a
critical step in preparation for launch by allowing Cardiome to
start negotiating with individual hospitals to gain formulary
access for XYDALBA. Cardiome expects to make its first commercial
sale in the UK before the end of 2016. We also continue to receive
excellent feedback from our other countries as we prepare to offer
physicians access to this unique dosage regimen that provides a new
treatment approach giving patients, healthcare professionals and
hospitals greater flexibility in managing serious skin
infections."
About XYDALBATM
XYDALBA
(dalbavancin) for injection is a second-generation,
semi-synthetic lipoglycopeptide, which consists of a lipophilic
side-chain added to an enhanced glycopeptide backbone. XYDALBA
is the first and only 30-minute, one-dose treatment option for
acute bacterial skin and skin structure infections (ABSSSI) that
delivers a full course of IV therapy. XYDALBA can be administered
as either one 1500 mg dose or as a two-dose regimen of 1000 mg
followed one week later by 500 mg, each administered over 30
minutes. XYDALBA demonstrates bactericidal activity in vitro
against a range of Gram-positive bacteria, such
as Staphylococcus aureus (including
methicillin-resistant, also known as MRSA, strains)
and Streptococcus pyogenes, as well as certain other
streptococcal species.
About Cardiome Pharma Corp.
Cardiome Pharma Corp. is a
specialty pharmaceutical company dedicated to the development and
commercialization of innovative therapies that will improve the
quality of life and health of patients suffering from disease.
Cardiome has two marketed, in-hospital, cardiology products,
BRINAVESS® (vernakalant IV), approved in Europe and other territories for the rapid
conversion of recent onset atrial fibrillation to sinus rhythm in
adults, and AGGRASTAT® (tirofiban HCl) a reversible GP
IIb/IIIa inhibitor indicated for use in patients with acute
coronary syndrome. Cardiome also commercializes
ESMOCARD® and ESMOCARD LYO® (esmolol
hydrochloride), a short-acting beta-blocker used to control rapid
heart rate in a number of cardiovascular indications, on behalf of
their partner AOP Orphan Pharma in select European markets.
Cardiome has also licensed: XYDALBA™ (dalbavancin), a second
generation, semi-synthetic lipoglycopeptide approved in the EU for
the treatment of acute bacterial skin and skin structure infections
(ABSSSI) in adults for select European and Middle Eastern nations
and Canada from Allergan; and
TREVYENT®, a development stage drug device combination
that is under development for Pulmonary Arterial Hypertension for
Europe, the Middle East and Canadian markets from
SteadyMed Therapeutics.
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 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 2016 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.