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 19, 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 19, 2019 | By: | /s/ Justin Renz |
| Name: Justin Renz | ||
| Title: President and Chief Financial Officer | ||
Exhibit 99.1
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 10, 2019 and December 11, 2019
| Item 3: | News Release |
News releases announcing the material changes were issued on December 10, 2019 and December 11, 2019 through Canada Newswire and copies were subsequently filed on SEDAR.
| Item 4: | Summary of Material Changes |
On December 10, 2019, Correvio announced that the U.S. Food and Drug Administration (“FDA”) Cardiovascular and Renal Drugs Advisory Committee (“CRDAC”) met to review the Company’s New Drug Application (“NDA”) seeking approval for Brinavess. The Committee jointly voted that the benefit-risk profile was not adequate to support approval (Vote: 2 Yes to 11 No). While the FDA is not required to follow the committee’s vote, the agency considers the committee’s recommendations when making its decision. Correvio’s NDA seeking approval for Brinavess is under review by the FDA with a target action date of December 24, 2019 under the Prescription Drug User-Fee Act (“PDUFA”).
On December 11, 2019, Correvio announced plans to explore strategic options to maximize stakeholder value. 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.
| Item 5: | Full Description of Material Change |
5.1 Full Description of Material Change
CRDAC Vote on Brinavess NDA
On December 10, 2019, Correvio announced that the FDA CRDAC met to review the Company’s NDA seeking approval for Brinavess. The Committee jointly voted that the benefit-risk profile was not adequate to support approval (Vote: 2 Yes to 11 No). Brinavess is Correvio’s anti-arrhythmic drug that is currently under review by the FDA for the rapid conversion of recent onset atrial fibrillation (“AF”) in adult patients. While the FDA is not required to follow the committee’s vote, the agency considers the committee’s recommendations when making its decision. Correvio’s NDA seeking approval for Brinavess is under review by the FDA with a target action date of December 24, 2019 under the PDUFA.
The CRDAC is an independent panel of experts that evaluates data concerning the efficacy and safety of marketed and investigational products for use in the treatment of cardiovascular and renal diseases and makes appropriate recommendations to the FDA. Although the FDA will consider the recommendation of the panel, the final decision regarding the approval of the product is made by the FDA solely, and the recommendations by the panel are non-binding.
Exploration of Strategic Alternatives
On December 11, 2019, Correvio announced plans to explore strategic options to maximize stakeholder value. 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.
To conserve its financial resources, Correvio intends to reduce its operating costs in North America, while concentrating its resources on only essential commercial and business development activities. Correvio has retained Piper Jaffray to assist in its review of strategic alternatives. Correvio has not set a timetable for completion of this review process and there can be no assurance that the exploration of strategic alternatives will result in any transaction being entered into or consummated.
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 19, 2019