Acerus Receives Notice of Deficiency – Withdrawal Letter from Health Canada Regarding Gynoflor™ Application
Acerus Pharmaceuticals Corporation (TSX: ASP) (“Acerus” or the “Company”) is today advising that it has received a Notice of Deficiency-Withdrawal Letter (“Notice”) for its GynoflorTM 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 GynoflorTM,” said Ed Gudaitis, President and CEO of Acerus Pharmaceuticals. “GynoflorTM 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 AG, the manufacturer and licensor of GynoflorTM, to assess our next steps.”
Acerus Pharmaceuticals Corporation is a Canadian-based specialty pharmaceutical company focused on the development, manufacture, marketing and distribution of innovative, branded products that improve patient experience, with a primary focus in the field of men’s and women’s health. The Company commercializes its products via its own salesforce in Canada, and through a global network of licensed distributors in the U.S. and other territories.
Notice Regarding Forward-Looking Statements
Information in this press release that is not current or historical factual information may constitute forward looking information within the meaning of securities laws. Implicit in this information are assumptions regarding our future operational results. These assumptions, although considered reasonable by the company at the time of preparation, may prove to be incorrect. Readers are cautioned that actual performance of the company is subject to a number of risks and uncertainties, including with respect to the regulatory approval and potential commercial success of GynoflorTM, and could differ materially from what is currently expected as set out above. For more exhaustive information on these risks and uncertainties you should refer to our annual information form dated March 20, 2018 which is available at www.sedar.com. Forward-looking information contained in this press release is based on our current estimates, expectations and projections, which we believe are reasonable as of the current date. You should not place undue importance on forward-looking information and should not rely upon this information as of any other date. While we may elect to, we are under no obligation and do not undertake to update this information at any particular time, whether as a result of new information, future events or otherwise, except as required by applicable securities law.
View source version on businesswire.com: https://www.businesswire.com/news/home/20190125005077/en/