UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 6-K
Report of Foreign Private Issuer
Pursuant to Rule 13A-16 or 15d-16 of
The Securities Exchange Act of 1934
For the month of December 2019
COMMISSION FILE Number. 000-29338
CORREVIO PHARMA CORP.
(Translation of registrant’s name into English)
1441 Creekside Drive, 6th floor
Vancouver, British Columbia, V6J 4S7, CANADA
(Address of principal executive offices)
Indicate by check mark whether the registrant files or will file annual reports under cover Form 20-F or Form 40-F
| Form 20-F ☐ | Form 40-F ☒ |
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): ☐
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): ☐
DOCUMENTS INCLUDED AS PART OF THIS REPORT
| Exhibit | Description | |
| 99.1 | Material Change Report dated December 24, 2019 | |
Exhibit 99.1 of this report on Form 6-K is incorporated by reference into the Company’s registration statement on Form F-10 (File No. 333-225852) and registration statements on Form S-8 (File No. 333-225015 and File No. 333-225014).
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
| CORREVIO PHARMA CORP. | ||
| (Registrant) | ||
| Date: December 26, 2019 | By: | /s/ Justin Renz |
| Name: Justin Renz | ||
| Title: President and Chief Financial Officer | ||
FORM 51-102F3
MATERIAL CHANGE REPORT
| Item 1: | Name and Address of Company |
Correvio Pharma Corp. (“Correvio”
or the “Company”)
1441 Creekside Drive, 6th Floor
Vancouver, British Columbia
Canada V6J 4S7
| Item 2: | Date of Material Changes |
December 24, 2019
| Item 3: | News Release |
The news release announcing the material changes was issued on December 24, 2019 through Canada Newswire and copies were subsequently filed on SEDAR.
| Item 4: | Summary of Material Changes |
On December 24, 2019, Correvio announced that it had received a Complete Response Letter (“CRL”) from the U.S. Food and Drug Administration (“FDA”) regarding the New Drug Application (“NDA”) for BrinavessTM (vernakalant IV) stating that the FDA determined that it cannot approve the Brinavess NDA in its present form and providing recommendations needed for resubmission.
On December 24, 2019, Correvio also announced that, since the Company’s announcement of the FDA’s Cardiovascular and Renal Drugs Advisory Committee (“CRDAC”) meeting outcome for Brinavess on December 10, 2019, the Company had received notice of claims being made against it in respect of that event. 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 stated its intention to counterclaim against the Company based on alleged breaches by the Company.
| Item 5: | Full Description of Material Change |
5.1 Full Description of Material Change
CRL regarding NDA for Brinavess
On December 24, 2019, Correvio announced that it had received a CRL from the FDA regarding the NDA for Brinavess, an anti-arrhythmic drug for the conversion of atrial fibrillation. 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 does 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. 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.
Litigation
Since the Company’s announcement of the FDA’s CRDAC meeting outcome for Brinavess on December 10, 2019, the Company has received notice of claims being made against it in respect of that event. Additionally, the Company has made a claim against 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.
5.2 Disclosure for Restructuring Transactions
Not applicable.
| Item 6: | Reliance on subsection 7.1(2) of National Instrument 51-102 |
Not applicable.
| Item 7: | Omitted Information |
Not applicable.
| Item 8: | Executive Officer |
Justin Renz, President and Chief Financial
Officer
Telephone: 604-677-6905
| Item 9: | Date of Report |
December 24, 2019