Acerus Announces NATESTO Regulatory Filing in South Korea

TORONTO--(BUSINESS WIRE)--Acerus Pharmaceuticals Corporation (TSX:ASP) announced today that Hyundai Pharm Co., Ltd. has filed for the marketing approval of NATESTO^® with the Ministry of Food and Drug Safety (MFDS) in South Korea. Hyundai Pharm acquired an exclusive license to market NATESTO^® in South Korea from Acerus in December 2016. If approved, NATESTO^® will be the first and only testosterone nasal gel indicated for the treatment of low testosterone in South Korea.

“We look forward to working with the MFDS regulatory authorities to bring NATESTO® to the South Korean market”

“Acerus is very pleased by the speed with which Hyundai Pharm has been able to prepare the dossier and file NATESTO^® with MFDS,” said Tom Rossi, President and Chief Executive Officer of Acerus. “It’s a testament to their commitment to the future success of NATESTO^®.”

“We look forward to working with the MFDS regulatory authorities to bring NATESTO^® to the South Korean market,” said Young Hak Kim, CEO and President of Hyundai Pharm Co., Ltd. “This product is an important advance for patients suffering from low testosterone in South Korea. Its unique nasal administration, safety and efficacy represent a clear opportunity to improve patient’s quality of life.”

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 and Health Canada and available in a ‘no-touch’ dispenser with a metered dose pump. A copy of the NATESTO^® Canadian product monograph can be found at: http://www.aceruspharma.com/English/products-and-pipeline/NATESTO^®/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 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

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 www.hyundaipharm.co.kr/english/index.jsp

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, 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 25, 2016 and Rogol et al. J Andrology 2015, 4(1), 46