NASDAQ: CRME TSX: COM
VANCOUVER, Dec. 8, 2016 /PRNewswire/ - Cardiome Pharma
Corp. (NASDAQ: CRME / TSX: COM) announced that it has launched
XYDALBA in the UK earlier than expected. The European Medicines
Agency (EMA) approved XYDALBA for the treatment of acute bacterial
skin and skin structure infections (ABSSSI) in adults. 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
intravenously over 30 minutes.
Commenting on the XYDALBA launch in the UK, Hugues Sachot,
Cardiome's Senior VP Commercial said, "This is an exciting moment
for Cardiome as we begin the commercial roll-out for XYDALBA across
our European territories. XYDALBA is a key product for Cardiome and
we've supported its launch by strengthening our regional European
teams with the addition of strong medical and commercial teams who
all have strong anti-infective expertise. The feedback we've
received about XYDALBA from our physician advisory boards has been
very positive and the flexible dosing options may hasten early
discharge, thereby increasing bed availability. We are excited to
have launched XYDALBA ahead of schedule."
"We are pleased that XYDALBA is now available to our medical
professionals in the UK," said Dr. Kiran
Bhirangi, Cardiome's Head of Medical Affairs. "The single
dose option provides the opportunity that the patient will get a
full course of antibiotic therapy without the need to return to the
hospital multiple times for follow-up dosing. We believe that
XYDALBA's efficacy as demonstrated in the DISCOVER
trials1 and its flexible dosing options will resonate
with our medical professionals by allowing them to choose how to
manage therapy based on their patients' needs and availability of
resources."
According to Datamonitor, the diagnosed incidence of ABSSSI was
~280,000 patients in 2012 and is expected to grow to over 400,000
by 2030.2 The UK ABSSSI hospital market is valued at
~$74M.3
References:
- Boucher HW, Wilcox M, Talbot GH, Puttagunta S, Das AF, Dunne
MW. Once-weekly dalbavancin versus daily conventional therapy for
skin infection. N Engl J Med. 2014;370(23):2169-2179
and Dunne MW, Puttagunta S, Giordano P, Krievins D, Zelasky M,
Baldassarre J. A randomized clinical trial of single dose vs weekly
dalbavancin for treatment of acute bacterial skin and skin
structure infection. Clin Infect
Dis. 2016;62(5):545-551.
- Datamonitor Healthcare. Skin and Skin Structure Infections:
Epidemiology. November 2013.
- IMS Midas, 2015.
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 hydrochloride), 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 for 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
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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
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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
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subsequent events or circumstances, except as required by law.
SOURCE Cardiome Pharma Corp.