CORV: Brinavess Continues to Hit Milestones

By John Vandermosten, CFA

NASDAQ:CORV | TSX:CORV

READ THE LATEST CORV RESEARCH REPORT

2018 has been an exciting year for Correvio Pharma Corp. (CORV) (CORV.TO), with several transformative events taking place. The company separated its Canadian commercial business, posted strong growth in anti-infective revenues and advanced of Brinavess on a number of fronts. Brinavess continues to achieve milestones with the recent conclusion of the pre-NDA meeting, confirmation of the timeline for FDA action and receipt of an opinion regarding an extension of the patent term.

The most exciting news for the year was the FDA’s announcement regarding the resubmission of Brinavess and the scheduling of a pre-NDA meeting. This is important as it clarifies the pathway towards approval in the United States. Not only will it open up the most valuable market to Brinavess, but also relieve concern in the rest of the world that the FDA harbors reservations about the drug.

We increased our valuation for the company based on the FDA allowing for the resubmission of the NDA and for progress made in China, which we addressed in our previous report. The company continues to achieve milestones which we highlight below.

On October 23, Correvio announced its intention to resubmit Brinavess in 2Q:19 following a pre-NDA meeting. The announcement came after the FDA confirmed that no additional studies were required in order for the agency to consider the application. Notes from the meeting are expected in late November, which will confirm the specifics discussed in the meeting. Based on the details provided, there is sufficient clinical and post-marketing data available to support the resubmission. According to the timeline in the latest presentation, a 2Q:19 submission suggests a 4Q:19 FDA response and a potential 2020 launch of the drug, which matches our estimates.

On October 29, Correvio announced that Brinavess may be eligible for a patent extension under the Patent Term Restoration program. The company received regulatory and legal opinions supportive of the extension based on the time the FDA held the drug under review. The program helps compensate patent holders for marketing time lost while the NDA is being considered by the FDA. A maximum of five years can be restored, but the extension cannot advance the protections beyond 14 years from the approval date. The restoration period is calculated by restoring one half of the duration of the testing phase plus the entire duration of the approval phase. Since the FDA has had the drug under consideration since 2008, we anticipate that the full five year extension will be granted and the revised expiration date will be March 16, 2031.

Third quarter 2018 financial and operational results are scheduled to be presented on November 6th and a conference call to be held after the close that day. We expect Correvio will provide an update on Brinavess progress at that time.

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