NASDAQ: CORV
TSX: CORV
VANCOUVER, Dec. 24, 2019 /CNW/ - Correvio Pharma Corp.
(NASDAQ: CORV) (TSX: CORV), a specialty pharmaceutical company
focused on commercializing hospital drugs, today announced it has
received a Complete Response Letter (CRL) from the U.S. Food and
Drug Administration (FDA) regarding the New Drug Application (NDA)
for Brinavess™ (vernakalant IV), an anti-arrhythmic drug for the
conversion of atrial fibrillation (AF). The CRL stated that
the FDA determined it cannot approve the Brinavess NDA in its
present form and provided recommendations needed for
resubmission.
In the CRL, the FDA stated that while the submitted data
provides substantial evidence of Brinavess' effectiveness, the data
do not provide reassuring evidence of Brinavess' safety. The
FDA indicated that Correvio will need to develop an approach to
select patients who are at low risk of adverse cardiovascular
reactions and that data from an additional, potentially
uncontrolled, clinical study will be needed to assess Brinavess'
cardiovascular risk in the selected patient population and to
support an NDA resubmission. The FDA also stated that the
risk of serious cardiovascular adverse reactions will need to be
much less than 1% in the selected patient population.
Correvio intends to request a meeting with the FDA as soon as
possible to discuss the design and specifics of a potential study
to address the FDA's concerns and currently believes that
enrollment of both US and ex-US subjects may be acceptable to the
Agency based on preliminary feedback. As previously
announced, Correvio is also exploring strategic alternatives for
the Company and/or its assets. Potential strategic
alternatives that may be evaluated include, but are not limited to,
an acquisition, merger, business combination or other strategic
transaction involving the Company or its assets.
Recent Events
The Company is involved in litigation in the normal course of
its business, both as a defendant and as a plaintiff. Since the
Company's announcement of the FDA's Cardiovascular and Renal Drugs
Advisory Committee (CRDAC) meeting outcome for Brinavess on
December 10, the Company has received
notice of claims being made against it in respect of that
event. The Company strongly believes there is no basis for
any such claims and intends to vigorously defend itself.
Additionally, the Company has made a claim against Eddingpharm
(Asia) Macau Commercial Offshore,
Ltd. ("Eddingpharm"), one of its former distributors for Aggrastat,
in respect of certain contractual breaches by Eddingpharm.
Eddingpharm has, in turn, stated its intention to
counterclaim against the Company based on alleged breaches by the
Company. The arbitration proceeding is still in its early
stages and Eddingpharm has not yet formally responded to the
Company's Statement of Claim. Although the Company strongly
believes in the strength of its claim and intends to vigorously
assert its rights, it is not possible at this early stage to
predict the outcome of the arbitration proceeding or the
probability or amount of any award that may be issued by the
Arbitration Tribunal.
About Correvio Pharma Corp.
Correvio Pharma Corp. is a 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, Correvio 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. Correvio'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.
Correvio is traded on the NASDAQ Capital Market (CORV) and the
Toronto Stock Exchange (CORV). For more information, please visit
our web site www.correvio.com.
Forward-Looking Statement Disclaimer
Certain statements in this news release contain "forward-looking
statements" within the meaning of the U.S. Private Securities
Litigation Reform Act of 1995 or "forward-looking information"
under applicable Canadian securities legislation (collectively,
"forward-looking statements"). Forward-looking statements include
statements that may relate to our plans, objectives, goals,
strategies, future events, future revenue or performance, capital
expenditures, financing needs and other information that may not be
based on historical fact. Forward-looking statements can often be
identified by the use of terminology such as "believe", "may",
"plan", "will", "estimate", "continue", "anticipate", "intend",
"expect", "look forward to" and similar expressions.
Forward-looking statements are necessarily based on estimates and
assumptions made by us based on our experience and perception of
historical trends, current conditions and expected future
developments, as well as other factors we believe are
appropriate.
By their very nature, 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. These
forward-looking statements include, but are not limited to,
statements relating to any regulatory path forward for Brinavess.
In particular, no statement herein should be understood to mean:
(i) that the FDA will agree to meet with us to address the concerns
expressed in the CRL; (ii) that the FDA will find any additional
clinical trial data we provide to be acceptable; (iii) that the FDA
will find our manufacturing sites acceptable and validate them; or
(iv) that, in the event the Company resubmits an NDA for Brinavess,
the FDA will approve it, will or will not require substantive Risk
Evaluation and Mitigation Strategies (REMS) and/or substantively
limit the product label. Furthermore, the timing of any
resubmission of an NDA for Brinavess, any action by the FDA or any
possible regulatory paths forward cannot be guaranteed, in that,
for example: (i) an additional, potentially uncontrolled,
clinical study to assess Brinavess' cardiovascular risk in the
selected patient population may not produce results that support a
resubmission; (ii) the FDA may not accept a resubmission, (iii) the
timing of any FDA review process is unknown; and (iv) the FDA may
require further information or additional clinical studies.
Finally, no statement provided herein should be understood to mean
that a strategic alternative can or will be found for the Company
or that the Company's assessment of the claims against it as having
no basis will prove to be accurate.
A detailed discussion of the risks and uncertainties facing
Correvio are discussed in the annual report and detailed from time
to time 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. In particular,
we direct your attention to Correvio's Annual Report on Form 40-F
for the year ended December 31, 2018
and its quarterly report filed November 14,
2019 for the third quarter of 2019. All of the risks and
certainties disclosed in those filings are hereby incorporated by
reference in their entirety into this news release.
While Correvio makes these forward-looking statements in good
faith, given these risks, uncertainties and factors, you are
cautioned not to place undue reliance on any forward-looking
statements made in this press release. All forward-looking
statements made herein are based on our current expectations and we
undertake no obligation to revise or update such forward-looking
statements to reflect subsequent events or circumstances, except as
required by law. Investors are cautioned that forward-looking
statements are not guarantees of future performance and accordingly
investors are cautioned not to put undue reliance on
forward-looking statements due to their inherent uncertainty.
Correvio® and the Correvio Logo are the proprietary
trademarks of Correvio Pharma Corp.
Aggrastat® and Brinavess®™ are trademarks owned by
Correvio and its affiliates worldwide.
Xydalba™ is a trademark of Allergan Pharmaceuticals
International Limited, and used under license.
Zevtera® and Mabelio® are trademarks owned by
Basilea Pharmaceutica International Ltd., and used under
license.
Trevyent® is a trademark of SteadyMed Ltd., a subsidiary
of United Therapeutics Corporation and used under license.
All other trademarks are the property of their respective
owners.
View original
content:http://www.prnewswire.com/news-releases/correvio-receives-complete-response-letter-from-us-fda-for-brinavess-and-provides-update-on-recent-events-300979132.html
SOURCE Correvio Pharma Corp