Acerus Files A New Drug Submission For GYNOFLOR In Canada

TORONTO--(BUSINESS WIRE)--Acerus Pharmaceuticals Corporation (TSX:ASP) today announced that it has filed a New Drug Submission (NDS) for GYNOFLOR™ with Health Canada. GYNOFLOR™ is an ultra-low dose estrogen (estriol) and probiotic (Lactobacillus acidophilus) combination vaginal tablet used for the treatment of symptoms of vaginal atrophy, for the restoration of vaginal flora following the use of anti-infectives and for the treatment of certain vaginal infections. In the NDS filed today, Acerus is seeking approval from Health Canada for similar indications.

“GYNOFLOR™ is a highly-differentiated product which, if approved, has the potential to help the many women who suffer from vaginal atrophy and certain vaginal infections, and contribute significant revenues to our Canadian business. We look forward to working with Health Canada and bringing GYNOFLOR™ to the Canadian market.”

“The filing of this NDS further demonstrates our commitment to expanding our women’s health portfolio and to providing innovative treatment options to Canadian,” said Tom Rossi, President and Chief Executive Officer of Acerus. “GYNOFLOR™ is a highly-differentiated product which, if approved, has the potential to help the many women who suffer from vaginal atrophy and certain vaginal infections, and contribute significant revenues to our Canadian business. We look forward to working with Health Canada and bringing GYNOFLOR™ to the Canadian market.”

About GYNOFLOR™

GYNOFLOR™ is an ultra-low dose estrogen (estriol) and probiotic (Lactobacillus acidophilus) combination vaginal tablet used for the treatment of symptoms of vaginal atrophy due to estrogen deficiency during menopause and post-menopause, for the restoration of vaginal flora following the use of anti-infectives and for the treatment of certain vaginal infections. GYNOFLOR™ is approved in 41 countries across Europe, Asia-Pacific, the Middle East, Africa and South America, and it is estimated that up to 32.7 million women worldwide have been treated with the product to date.

About Acerus

Acerus Pharmaceuticals Corporation is a Canadian pharmaceutical company focused on the development, manufacture, marketing and distribution of innovative, branded products that improve the patient experience. Acerus’ shares trade on TSX under the symbol ASP. For more information, visit www.aceruspharma.com and follow us on Twitter and LinkedIn.

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 ability of Acerus to obtain regulatory approval for GYNOFLOR™, 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 1, 2016 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.