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Press Release

Acerus Enters into a Licensing Agreement with Viramal to Commercialize the Elegant™ Franchise in Canada

Acerus Pharmaceuticals Corporation
Posted on: 20 Dec 17

Acerus Pharmaceuticals Corporation (TSX:ASP) (“Acerus” or the “Company”) today announced that it has entered into a license, development and supply agreement with Viramal Limited (“Viramal”), a London-based specialty pharmaceutical company developing therapeutics that improve the quality of women’s health, granting Acerus the exclusive rights to commercialize the Elegant™ franchise in Canada.

The Elegant™ franchise comprises Elegant™ Vaginal Moisturizer, which provides comfort to women suffering from vaginal dryness, and Elegant™ pH, which is a pH balanced vaginal product. Vaginal dryness is most common in post-menopausal women and those suffering from vaginal atrophy1. Vaginal dryness has been estimated to occur in 21% of women within one year of menopause and 47% by the third year of the menopausal transition2. Elegant™ Vaginal Moisturizer and Elegant™ pH are over-the-counter products designed to be a more user-friendly alternative over ReplensTM and RepHreshTM (both of which are trademarks of Church & Dwight Co. Inc.), which are market leaders in Canada.

“We are pleased to be partnering with Viramal to bring these innovative products to the Canadian market. This partnership strengthens Acerus’ position as a leader in women’s health and will allow Acerus to continue to focus on improving the patient experience for Canadian women,” said Tricia Symmes, Chief Operating Officer of Acerus.

Luc Mainville, Interim Chief Executive Officer of Acerus, added: “This is a great partnership for Acerus as the ElegantTM franchise is very well-aligned with our strategy of leveraging existing resources. Acerus expects to make submissions to Health Canada in the second half of 2018, leading to product launches in the first half of 2019, if approved.”

Oliver Bates, Chief Executive Officer of Viramal, noted: “Viramal is pleased to complete this licensing transaction for the ElegantTM franchise. We are proud to have developed a product which delivers the same benefits as ReplensTM and RepHreshTM while improving the patient experience, facilitated by Viramal’s proprietary and patented Elegant™ platform technology. We are confident that Acerus’ product portfolio and strategic focus will ensure the success of the ElegantTM franchise in Canada.”

Under the terms of the license, development and supply agreement, Viramal will receive a regulatory milestone payment upon Acerus receiving marketing approval in Canada, as well as milestone payments based on achieving sales targets. Viramal will oversee the manufacturing of ElegantTM 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 two innovative products: 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; and TEFINA™, a clinical stage product aimed at addressing a significant unmet need for women with female sexual dysfunction. 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 Viramal

Viramal is an emerging specialty pharmaceutical company focused on the development of global therapeutics that improve the quality of women’s health worldwide. Viramal is developing innovative products that target unmet therapeutic areas through the use of its unique pharmaceutical delivery platforms and technologies. These new therapies are anticipated to provide greater efficacy and patient acceptability, with far fewer side effects. Viramal’s robust women’s health clinical development pipeline includes treatments for endometriosis and fertility, menopausal hormone therapy, contraception, sexual health and other potential indications.

For more information, visit www.viramal.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 regulatory approval and potential commercial success of ElegantTM 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 law.

References

1. Journal of Obstetrics and Gynaecology Canada 2014; 36(9): Supplement 2.
2. Dennerstein L, Dudley EC, Hopper JL, Guthrie JR, Burger HG. A prospective population-based study of menopausal symptoms. Obstet Gynecol 2000;96:351–8.

View source version on businesswire.com: http://www.businesswire.com/news/home/20171220005153/en/

Business Wire
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Last updated on: 20/12/2017

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