NASDAQ:CRME TSX:COM
VANCOUVER, July 3, 2017 /CNW/ - 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.
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