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Acerus Enters into a Licensing Agreement with Innovus to Commercialize UriVarx® in Canada

01/08/2018

TORONTO--(BUSINESS WIRE)-- Acerus Pharmaceuticals Corporation (TSX:ASP) (“Acerus” or the “Company”) today announced that it has entered into an exclusive distributor and license agreement with Innovus Pharmaceuticals, Inc. (OTCQB: INNV) (“Innovus”), a California-based specialty pharmaceutical company developing safe and effective over-the-counter medicines, granting Acerus the exclusive rights to commercialize UriVarx® in Canada.

UriVarx® is a Natural Health Product (NHP) that helps reduce symptoms of hyperactive bladder such as daytime urinary frequency, urgency and nocturia. The product was recently approved by Health Canada and will be offered over-the-counter to Canadians dealing with such symptoms.

Nearly 1 in 5 Canadians over the age of 35 experience overactive bladder symptoms1. Men and women’s lives are directly impacted by an overactive bladder, and the current treatment options may come with systemic side effects.

“This is a great partnership for Acerus as UriVarx® is well-aligned with our strategy of optimizing our existing presence in urology and maintaining an active dialogue with Canadian patients. As UriVarx® is already approved by Health Canada, the Acerus team expects to launch the product in the second half of 2018, thereby potentially generating meaningful revenues this year,” said Tricia Symmes, Chief Operating Officer of Acerus.

“We are pleased to be partnering with Innovus to bring this innovative NHP, with a strong clinical data package, to the Canadian market. Moving forward we will continue to proactively seek similar opportunities that can leverage our existing salesforce as well as provide accelerated financial returns,” added Luc Mainville, Interim Chief Executive Officer of Acerus.

Bassam Damaj, President and Chief Executive Officer of Innovus, noted: “We are confident that Acerus Pharmaceuticals is an excellent partner to bring UriVarx® to the Canadian market, with an established dedicated presence in Canadian men and women’s health as well as in urology.”

Under the terms of the exclusive distributor and license agreement, Innovus will receive a payment at signing, as well as milestone payments based on Acerus achieving certain sales targets. Innovus will oversee the manufacturing of UriVarx® and will receive a supply price for the product.

About Acerus

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.

Acerus currently has two marketed products: ESTRACE®, a product for the symptomatic relief of menopausal symptoms, is commercialized in Canada; and NATESTO®, the first and only testosterone nasal gel for testosterone replacement therapy in adult males diagnosed with hypogonadism, is commercialized in Canada and the U.S. In addition, NATESTO® has been licensed for distribution in 30 countries worldwide. Marketing approvals in jurisdictions outside of North America are expected to take place over the course of the coming years. Acerus’ pipeline includes three innovative product lines: GYNOFLOR, an ultra-low dose vaginal estrogen combined with a probiotic, for which a NDS has been filed in Canada for the treatment of vaginal atrophy, restoration of vaginal flora and treatment of certain vaginal infections; TEFINA, a clinical stage product aimed at addressing a significant unmet need for women with female sexual dysfunction; and ELEGANT, a franchise comprised of ELEGANT Vaginal Moisturizer, which provides comfort to women suffering from vaginal dryness, and ELEGANT pH, which is a pH balanced vaginal product. Finally, the Company owns or has a license to numerous patents relating to proprietary delivery systems as well as novel formulations of products currently in the early stage of development.

Acerus’ shares trade on TSX under the symbol ASP. For more information, visit www.aceruspharma.com and follow us on Twitter and LinkedIn.

About Innovus

Headquartered in San Diego, Innovus is an emerging OTC consumer goods and specialty pharmaceutical company engaged in the commercialization, licensing and development of safe and effective non-prescription medicine and consumer care products to improve men’s and women’s health and vitality and respiratory diseases. Innovus delivers innovative and uniquely presented and packaged health solutions through its (a) OTC medicines and consumer and health products, which it markets directly, (b) commercial partners to primary care physicians, urologists, gynecologists and therapists, and (c) directly to consumers through its on-line channels, retailers and wholesalers. Innovus is dedicated to being a leader in developing and marketing new OTC and branded Abbreviated New Drug Application (“ANDA”) products. Innovus is actively pursuing opportunities where existing prescription drugs have recently, or are expected to, change from prescription (or Rx) to OTC.

For more information, go to www.innovuspharma.com.

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 commercial success of UriVarx® in Canada, 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 7, 2017 that 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 laws.

References

1 http://www.canadiancontinence.ca/EN/overactive-bladder-vs-sui.php

Source: Acerus Pharmaceuticals Corporation

Acerus Pharmaceuticals Corporation

Tricia Symmes, 416-509-2116

Chief Operating Officer

tsymmes@aceruspharma.com

or

Innovus Pharmaceuticals, Inc.

Investor Relations, 858-964-5123

IR@InnovusPharma.com