Correvio Pharma Corp. recently issued the following announcement.
Correvio Pharma Corp. (NASDAQ: CORV) (TSX: CORV), a specialty pharmaceutical company focused on commercializing hospital drugs, 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.
Original source can be found here.
