Acerus Announces Approval of NATESTO® in South Korea

TORONTO–(BUSINESS WIRE)–Acerus Pharmaceuticals Corporation (TSX:ASP) (Acerus or the Company”)
announced today that Hyundai Pharm Co., Ltd. (Hyundai), Acerus’
licensee, reported that South Korea’s Ministry of Food and Drug Safety
(MFDS) has approved NATESTO® for the treatment of

“Acerus is very pleased by the speed with which Hyundai has been able to
prepare the dossier and collaborate with the MFDS to obtain a notice of
approval for NATESTO® in South Korea. This approval marks an
important milestone in establishing NATESTO® globally as this
is the first regulatory approval outside of North America,” said Ed
Gudaitis, President and Chief Executive Officer of Acerus

Acerus will receive a regulatory milestone payment linked to the
regulatory approval. Additionally, Acerus will oversee ongoing
manufacturing of NATESTO® and receive a supply price for
product. Commercial launch is planned in Q4 2018.

About NATESTO® (Testosterone) Nasal Gel

NATESTO® is a nasal gel formulation of testosterone developed
by Acerus Pharmaceutical Corporation and indicated as a replacement
therapy for men diagnosed with conditions associated with a deficiency
or absence of endogenous testosterone (hypogonadism). It is the first
and only nasally-administered testosterone product approved by the U.S.
FDA, Health Canada and South Korea and available in a ‘no-touch’
dispenser with a metered dose pump. A copy of the NATESTO®
Canadian product monograph can be found at:®/default.aspx.
For further information, specific to the U.S. product dosing and
administration, please visit: www.NATESTO®.com.

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 three marketed products: ESTRACE®, a
product for the symptomatic relief of menopausal symptoms, is
commercialized in Canada; 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.; and URIVARX®, a Natural Health Product that helps
reduce symptoms of hyperactive bladder such as daytime urinary
frequency, urgency and nocturia. URIVARX® was recently
approved by Health Canada and will be offered over-the-counter to
Canadians dealing with such symptoms. Also, NATESTO® has been
licensed for distribution in 48 additional 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 six innovative products: avanafil, a new chemical
entity PDE5 inhibitor for the treatment of erectile dysfunction, which
has been approved by the US FDA and the EU EMA and is commercialized in
the US under the trade name STENDRA® and in the EU under the
trade name SPEDRA®; SHACT, a short acting
lidocaine formulation delivered through a proprietary device into the
vaginal mucosal tissue; ELEGANT Vaginal Moisturizer, which
provides comfort to women suffering from vaginal dryness, and ELEGANT
pH, which is a pH balanced vaginal product; 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, Acerus is working on expanding its product
portfolio by leveraging its proprietary delivery systems, patents and
formulation expertise. As such, Acerus has a number of products in
various stage of development. One of these projects relates to
cannabinoids (whether synthetic or naturally derived cannabinoids) to be
delivered intranasally to patients, which may have multiple possible
therapeutic applications (the “Cannabinoids Initiative”). Acerus has
filed patent applications on the Cannabinoids Initiative, is currently
working on setting up a series of pharmacokinetic clinical trials and is
actively looking at potential partnering transactions for these

Acerus’ shares trade on TSX under the symbol ASP. For more information,
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About Hyundai Pharm Co., Ltd.

Founded in 1965, HYUNDAI Pharm Co., Ltd. is a pharmaceutical company
engaged in R&D, manufacturing and distribution of pharmaceutical
products, health and food drinks, as well as medical equipment. In the
pharmaceutical field, HYUNDAI is a leading expert in various therapeutic
categories (CV, respiratory system, women’s & men’s health, CNS, and
oncology) with specialized and unique products. The company is head
quartered in Seoul, South Korea and is publicly traded on the Korea
Stock Exchange. For more information, visit

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
NATESTO® in South Korea, 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 20, 2018 that is available at
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.


1. NATESTO® Product Monograph, October 25, 2016 and Rogol et
al. J Andrology 2015, 4(1), 46


Acerus Pharmaceuticals Corporation
Tricia Symmes, 416-509-2116
Operating Officer