NASDAQ:CRME TSX:COM
VANCOUVER, July 3, 2017 /PRNewswire/ - Cardiome Pharma Corp.
(NASDAQ:CRME / TSX:COM) today announced that partner SteadyMed Ltd
(NASDAQ:STDY) submitted a New Drug Application (NDA) to the U.S.
Food and Drug Administration (FDA) for TREVYENT®
(treprostinil injection). TREVYENT® is a drug-device
combination product that utilizes SteadyMed's PatchPump®
technology to deliver treprostinil, a vasodilatory prostacyclin
analogue, for the treatment of pulmonary arterial hypertension
(PAH).
PatchPump® is a proprietary, disposable, parenteral
drug administration platform that is prefilled and preprogrammed at
the site of manufacture. Cardiome licensed the commercial rights to
TREVYENT® for many international markets in June 2015. Cardiome expects to file
TREVYENT® for European Medicines Agency (EMA) and Health
Canada approval by the end of 2017.
"The NDA filing with the FDA is an important step in the
development of TREVYENT®, and advances us closer to our
goal of bringing what we believe is a better way to deliver
treprostinil to patients around the world who are suffering from
PAH," said Hugues Sachot, Cardiome's Chief Commercial Officer. "Our
partnership with SteadyMed continues to progress well, and we will
work closely with them to file with both the EMA and Health Canada
by the end of this year."
About Pulmonary Arterial Hypertension
Pulmonary
arterial hypertension (PAH) is a type of high blood pressure that
occurs in the right side of the heart and in the arteries that
supply blood to the lungs. PAH worsens over time and is
life-threatening because the pressure in a patient's pulmonary
arteries rises to dangerously high levels, putting a strain on the
heart. There is no cure for PAH, but several medications are
available to treat symptoms, such as the market-leading
prostacyclin PAH therapy, Remodulin® (treprostinil
injection), which is produced by United Therapeutics Corporation.
The annual cost of Remodulin is reported to be between
approximately $125,000 and $175,000
per patient and United Therapeutics reported Remodulin revenues of
$602 million in 2016.
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 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.