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