BRIEF—Acerus receives notice from Health Canada on Gynoflor application

Shares of Canada’s Acerus Pharmaceuticals slumped 10.2% to C$0.11 on Friday, after the company said it has received a Notice of Deficiency-Withdrawal Letter for its Gynoflor, an ultra-low dose vaginal estrogen therapy with the addition of lactobacillus, New Drug Submission.

The company has 30 days to decide if it wishes to file a Letter of Intent to file a Request for Reconsideration of the Notice.

“We are disappointed with the Health Canada decision on Gynoflor,” Ed Gudaitis, president and chief executive of Acerus Pharmaceuticals.

“Gynoflor is currently approved in over 40 countries across Europe, Asia, the Middle East, Africa and South America and we are understandably surprised that we could not obtain approval in Canada. We will study the details of the Notice and work with Medinova, the manufacturer and licensor of Gynoflor, to assess our next steps,” he added.