Acerus Acquires Canadian Rights To GYNOFLOR

TORONTO--(BUSINESS WIRE)--Acerus Pharmaceuticals Corporation (TSX:ASP) today announced that it has entered into a license and supply agreement with Medinova AG, a Swiss pharmaceutical company, granting Acerus the exclusive rights to commercialize GYNOFLOR™ in Canada.

“GYNOFLOR™ is a novel product which, if approved, has the potential to contribute significant revenues to our Canadian business. We look forward to bringing this highly differentiated product to market as expeditiously as possible.”

GYNOFLOR™ is an ultra-low dose estrogen (estriol) and lactobacillus combination vaginal tablet used for the treatment of atrophic vaginitis due to estrogen deficiency during menopause, for the restoration of vaginal flora following the use of anti-infectives and for the treatment of certain vaginal infections. Currently, there are no approved products in Canada containing estriol, or the unique combination of estrogen and lactobacillus.

GYNOFLOR™ is approved in 39 countries across Europe, Asia-Pacific, the Middle East, Africa and South America. It was first approved in Germany in 1982 and it is estimated that up to 28 million women worldwide have been treated with the product to date. In addition, a total of 4,655 women have been studied as part of its extensive clinical trial program.

“This transaction strengthens our current women’s health portfolio and supports our strategic objective of expanding our presence in this therapeutic space,” said Tom Rossi, President and Chief Executive Officer of Acerus. “GYNOFLOR™ is a novel product which, if approved, has the potential to contribute significant revenues to our Canadian business. We look forward to bringing this highly differentiated product to market as expeditiously as possible.”

Under the terms of the licensing agreement, Medinova AG will supply finished product to Acerus at a fixed price. Acerus plans to submit a New Drug Submission to Health Canada and will consult with the agency in order to ensure that all requirements are met prior to filing.

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 markets ESTRACE® in Canada, a product indicated for the symptomatic relief of menopausal symptoms. NATESTO™, a product utilizing an Acerus licensed nasal gel technology, is the first and only testosterone nasal gel approved in Canada, and available in the United States for replacement therapy in adult males diagnosed with hypogonadism. GYNOFLOR™, a product licensed to Acerus in Canada by Medinova AG, is an ultra-low dose vaginal estrogen therapy with the addition of lactobacillus, for the treatment of atrophic vaginitis, certain vaginal infections and to restore a healthy vaginal environment. TEFINA™, a ‘use as required’ nasal testosterone gel, is an Acerus drug development candidate aimed at addressing a significant unmet need for women with female sexual dysfunction.

For more information, visit www.aceruspharma.com and follow us on Twitter and LinkedIn.

About Medinova

Medinova AG was founded in 1945 as a pharmacy in Zurich, Switzerland by Dr. Fritz Müller. Over the following decades, Medinova quickly grew its business operations and production facilities, manufacturing pharmaceutical specialty products for pharmacists and synthesizing chemical raw materials for various foreign markets.

Today, Medinova markets and distributes prescription drugs and over-the-counter products in gynaecology, dermatology, rheumatology and other therapeutics areas to over 45 countries worldwide. The company maintains active management throughout the life cycle of its core products and is committed to the highest defined quality standards, achieving continuous growth through its broad network of partners.

For more information, visit http://www.medinova.ch/en/.

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.