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Acerus Announces Licensing of NATESTO® in South East Asian Countries

10/17/2017

TORONTO--(BUSINESS WIRE)-- Acerus Pharmaceuticals Corporation (TSX:ASP) today announced the signing of an agreement granting Eu Hwa Pte LTD. (“EU”) the exclusive right to market NATESTO® in Thailand, Malaysia/Brunei, Singapore, Vietnam, Philippines, Hong Kong/Macau and one other small South East Asian country. EU is a subsidiary of one of Taiwan’s largest pharmaceutical companies, which has more than 800 employees worldwide as well as more than 300 dedicated pharmaceutical commercial employees with expertise across multiple therapeutic areas in South East Asia, including endocrinology and urology (the “SEA Partner”).

“We are delighted to be partnering with the SEA Partner for the commercialization of NATESTO® in South East Asia as it is a great partner for these markets, and we believe the commercial opportunity for NATESTO® in these territories is promising,” said Tricia Symmes, Chief Operating Officer of Acerus. “This agreement is another significant step in the execution of our strategy of expanding the NATESTO® platform on a global scale,” said Luc Mainville, Interim Chief Executive Officer of Acerus.

Under the terms of the agreement, Acerus will receive a non-refundable upfront fee and is eligible to receive a milestone upon submission of certain regulatory data to the SEA Partner in addition to a regulatory milestone payment upon the SEA Partner receiving marketing approval in the first country in its territory. Acerus will oversee the manufacturing of NATESTO® and will receive a supply price for the product. If approved, NATESTO® will be the first and only testosterone nasal gel for androgen replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone (hypogonadism) in South East Asia.1

About NATESTO® (Testosterone) Nasal Gel

NATESTO® is approved and available in Canada for replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone (hypogonadism). NATESTO® is a testosterone nasal gel available in a “no-touch” dispenser with a metered dose pump for reduced transference risk. The recommended starting dose of NATESTO® in Canada is 11 mg of testosterone (one actuation per nostril) administered twice daily for a total daily dose of 22 mg, the lowest topical gel testosterone dose approved in Canada. A copy of the NATESTO® product monograph can be found at: http://www.aceruspharma.com/English/products-and-pipeline/natesto/default.aspx.

NATESTO® is also approved and available in the United States. For further information, specific to the U.S. product dosing and administration, please visit: www.NATESTO.com.

About Acerus

Acerus Pharmaceuticals Corporation is a fully-integrated, Canadian specialty pharmaceutical company engaged in the development, manufacture, marketing and distribution of innovative, branded products in Men’s and Women’s Health. 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 regulatory approval of NATESTO® in South East Asia and the achievement of the milestone payments by Acerus, 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. NATESTO® Product Monograph, October 25th, 2016 and Rogol et al. J Andrology 2015, 4(1), 46.

Source: Acerus Pharmaceuticals Corporation

Acerus Pharmaceuticals Corporation

Tricia Symmes, 416-509-2116

Chief Operating Officer

tsymmes@aceruspharma.com