NDA Expected to be Filed and Accepted by the
End of 2018
NASDAQ:CRME TSX:COM
VANCOUVER, Dec. 11, 2017 /PRNewswire/ - Cardiome Pharma
Corp. (NASDAQ:CRME / TSX:COM), a revenue-generating, specialty
pharmaceutical company focused on commercializing hospital drugs,
today highlighted that its partner SteadyMed Therapeutics
(NASDAQ:STDY) has reached agreement with the U.S. Food and Drug
Administration (FDA) on the work necessary to resubmit the New Drug
Application (NDA) for Trevyent® for the treatment of
pulmonary arterial hypertension (PAH).
Based on written feedback received from the FDA, SteadyMed
indicated that is not required to conduct any clinical trials to
prove the safety or efficacy of Trevyent and that the FDA has
agreed that certain in vitro design verification (DV) tests
on the final to-be-marketed Trevyent product, supported by
pharmacokinetic modelling and process validation, should be
adequate for the resubmission and acceptance of the 505(b)(2) NDA.
SteadyMed has stated their expectation that the results of this
in vitro DV testing will be available around mid-2018 and
that they expect to both NDA submission and acceptance to occur
before the end of 2018. Cardiome plans to submit regulatory
filings for Trevyent in Europe and
Canada shortly following
SteadyMed's NDA resubmission to the FDA.
William Hunter, MD, CEO and
President of Cardiome stated, "Gaining clarity on the Trevyent NDA
pathway and timing is an important, positive development for both
SteadyMed and Cardiome. We believe Trevyent represents a better way
to deliver treprostinil to patients around the world who are
suffering from PAH and we will continue to work diligently to
prepare our planned regulatory filings for Europe and Canada, which we expect to submit shortly
following SteadyMed's NDA filing to the U.S. FDA."
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 sodium), 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 Trevyent®
Designed to address the limitations of existing pulmonary
arterial hypertension (PAH) therapies, SteadyMed's Trevyent is an
investigational drug product which combines a preservative-free,
parenteral formulation of treprostinil, a vasodilatory prostacyclin
analogue, with SteadyMed's proprietary PatchPump®.
Trevyent is a sterile, pre-filled, pre-programmed, single use
disposable infusion system that is in development for the initial
indication of continuous subcutaneous infusion of treprostinil for
the treatment PAH. Cardiome licensed the commercial rights to
Trevyent for the international markets of Europe, Canada and the Middle East and plans to file regulatory
submissions for Trevyent in Europe
and Canada following SteadyMed's
filing of a New Drug Application in the U.S. in 2018.
About Cardiome Pharma Corp.
Cardiome Pharma Corp. is a revenue-generating, specialty
pharmaceutical company focused on providing innovative,
high-quality brands that meet the needs of acute care physicians
and patients. With a commercial presence and distribution
network covering over 60 countries worldwide, Cardiome develops,
acquires and commercializes brands for the in-hospital, acute care
market segment. The Company's portfolio of approved and
marketed brands includes: Xydalba™ (dalbavancin hydrochloride), for
the treatment of acute bacterial skin and skin structure infections
(ABSSSI); Zevtera®/Mabelio® (ceftobiprole medocaril sodium), a
cephalosporin antibiotic for the treatment of community- and
hospital-acquired pneumonia (CAP, HAP); Brinavess® (vernakalant IV)
for the rapid conversion of recent onset atrial fibrillation to
sinus rhythm; Aggrastat® (tirofiban hydrochloride) for the
reduction of thrombotic cardiovascular events in patients with
acute coronary syndrome, and Esmocard® and Esmocard Lyo® (esmolol
hydrochloride), a short-acting beta-blocker used to control rapid
heart rate in a number of cardiovascular indications. Cardiome's
pipeline of product candidates includes Trevyent®, a drug device
combination that is designed to deliver Treprostinil, the world's
leading treatment for pulmonary arterial hypertension.
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 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; and 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
November 14, 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.
Cardiome® and the Cardiome Logo are the proprietary
trademarks of Cardiome Pharma Corp.
Aggrastat® and Brinavess® are trademarks
owned by Cardiome and its affiliates worldwide.
Xydalba® is a trademark of Durata Therapeutics Holding
C.V., and used under license.
Zevtera® and Mabelio® are trademarks owned by
Basilea Pharmaceutica International Ltd., and used under
license.
Esmocard® and Esmocard Lyo® are trademarks
owned by Orpha-Devel Handels und Vertriebs GmbH, and used under
license.
Trevyent® is a trademark of SteadyMed and used under
license.
All other trademarks are the property of their respective
owners.
SOURCE Cardiome Pharma Corp.