Acerus Announces Licensing of NATESTO in Brazil

TORONTO--(BUSINESS WIRE)-- Acerus Pharma (TSX:ASP) today announced the signing of an agreement granting Apsen Farmacêutica (Apsen) the exclusive right to market NATESTO^® in Brazil. Apsen is a leading Brazilian based pharmaceutical company with over 40 products and 1,100 employees in that country.

“We are pleased to be partnering with Apsen, a leading Brazilian pharmaceutical company, for the commercialization of NATESTO^® in this important market. Apsen has a proven commercial expertise in the field of urology, and boasts of strong relationships with specialists and primary care physicians,” said Tricia Symmes, Chief Operating Officer of Acerus. “Brazil is a large and fast growing market for pharmaceuticals and partnering with a strong local player represents another significant step in the worldwide commercialization of NATESTO, said Luc Mainville, Interim Chief Executive Officer of Acerus.”

“Apsen values collaborative opportunities in niche, innovative therapies, and we believe NATESTO^® is an important advance for patients suffering from hypogonadism in Brazil. Its unique nasal administration, safety and efficacy represent a clear opportunity to improve patient quality of life in this country,” said Renato Spallicci, President of Apsen.

Under the terms of the license, development and supply agreement, Acerus will receive a non-refundable upfront fee, with a first instalment paid at signing and the remaining payable upon regulatory approval. Acerus will oversee the manufacturing of NATESTO^® and 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 Brazil.¹

About NATESTO^® (Testosterone) Nasal Gel

NATESTO^® is approved and available in Canada and the United States for replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone (hypogonadism). NATESTO^®’s marketing approval is pending in South Korea and filings are expect to be made in other jurisdictions over the course of the coming years. NATESTO^® is a testosterone nasal gel available in a “no-touch” dispenser with a metered dose pump for reduced transference risk. In Canada, the recommended starting dose of NATESTO^® 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.

For 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 the patient experience, with a primary focus in the field of men’s and women’s health.

Acerus currently has two marketed products. ESTRACE^®, a product for the symptomatic relief of menopausal symptoms is commercialized by Acerus 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 United States. In addition, NATESTO^® has been licensed for distribution in 29 countries worldwide, via the Company’s international partners. Marketing approvals in those other jurisdictions would be expected over the course of the coming years Acerus’ pipeline includes two new 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 atrophic vaginitis, 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.

Acerus’ shares trade on TSX under the symbol ASP. For more information, visit www.aceruspharma.com and follow us on Twitter and LinkedIn.

About Apsen

The company was founded in 1969 and is based in São Paulo, Brazil. Apsen is a 100% Brazilian company owned by the Spallicci family.

Apsen is engaged in the research and development, manufacture, and sale of innovative pharmaceutical products in Brazil. It offers products in the areas of urology, rheumatology, ENT, neurology, geriatrics, psychiatry, gynecology, gastroenterology, pediatrics, orthopedics and general medicine.

With a mission to research, develop and deliver innovative products, Apsen has an ongoing commitment to improve quality of life and invests in social, cultural and sports activities.

For more information, visit www.apsen.com.br

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

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