NASDAQ:CRME TSX:COM
VANCOUVER, June 21, 2017 /CNW/ - Cardiome Pharma Corp.
(NASDAQ:CRME / TSX:COM) today announced that its affiliate has
signed an exclusive license and distribution agreement with Tzamal
Medical Ltd. ("Tzamal") that will advance XYDALBA™ toward
commercialization in Israel. As
part of the agreement, Tzamal will be responsible for obtaining
regulatory and pricing approvals for XYDALBA™ from Israel's Ministry of Health. Cardiome will
receive an upfront payment, as well as additional payments, based
upon commercial achievements and sales of XYDALBA™. Additional
terms were not disclosed.
"Tzamal is a proven leader at providing Israel's hospitals with high-quality
medications across a number of therapeutic areas including
anti-infectives," said Hugues Sachot, Cardiome's Chief Commercial
Officer. "Cardiome recently announced its launch of XYDALBA™ in the
major markets of the U.K., France
and Germany, and extending the
availability of XYDALBA™ to Israel
is a logical step in commercializing this important medicine across
the territories we cover."
"Based on the high-quality registration file of XYDALBA™, we
expect to complete a timely registration and launch within the next
12 to 18 months, and we are confident that the product's unique
benefits will position it as a first-choice treatment for its
approved indications and the important underserved market segment
it targets," said Edi Steinberg,
General Manager of Tzamal Bio Pharma Ltd.
XYDALBA™ was approved by the European Medicines Agency (EMA) on
February 19, 2015 as a treatment for
Acute Bacterial Skin and Skin Structure Infections (ABSSSIs) in
adults and by the U.S. Food and Drug Administration (FDA) on
May 23, 2014 for the treatment of
adult patients with ABSSSI caused by susceptible Gram-positive
bacteria, including MRSA. Dalbavancin is commercialized under the
trade name DALVANCE® in the U.S. and XYDALBA™ in certain
countries outside the U.S.
About XYDALBA™
XYDALBA™ for infusion 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, Canada, 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 Amomed 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 2017 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 or 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. These and other
risks are described in the Form 40F and associated documents filed
March 29, 2017 (see for example,
"Risk Factors" in the Annual Information Form for the year ended
December 31, 2016), in the Form 6-K
filed May 15, 2017, and in our other
filings with the Securities and Exchange Commission ("SEC")
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.