Acerus Provides Update on Continuing Commercial and R&D Achievements for NATESTO®

Acerus Pharmaceuticals Corporation (TSX: ASP) (“Acerus” or the “Company”) is today providing an update on a number of significant operational and research achievements related to NATESTO^®, one of the Company’s core strategic assets.

NATESTO^® growth accelerates in Canada

• Total prescriptions (TRx) for NATESTO^® in Canada reached a new all time high of 1,627 in the month of October, growing 17.6% over total prescriptions in September.
• New prescriptions (NRx) for NATESTO^® in Canada grew by 19.5% October versus September.
• NATESTO^®’s share of the Topical Testosterone prescription market achieved a new high of 6.8% (in Alberta, British Columbia, Ontario and Quebec combined).
• NATESTO^®achieved a 7.5% total prescription share of the Topical Testosterone market in Ontario, gaining 1.1% market share points versus September.

Positive Interim Spermatogenesis Data

An update to the positive interim results from the NATESTO^® Spermatogenesis Study was presented at the 19th Annual Fall Scientific Meeting of the Sexual Medicine Society of North America meeting held in Miami, FL November 8-11, 2018. The interim read-out further demonstrates the restoration of hypogonadal patients’ serum testosterone levels while maintaining normal semen parameters for a larger group of study participants than was previously reported on September 17, 2018.

• Thirty-nine patients have been enrolled in the study.
  • Fourteen NATESTO^®-treated patients have been evaluated at their three-month treatment timepoint, reflecting one complete sperm cycle.
  • Nine NATESTO^®-treated patients have been evaluated at their six-month treatment timepoint, reflecting two sperm cycles.
• Zero patients in the study have become azoospermic during the study.
• Across the cohort of patients treated for three and six months, all three measured semen parameters were maintained.

The NATESTO^® Spermatogenesis Study is a single-center, prospective study evaluating testosterone levels, gonadotropin levels, and semen parameters in 40 hypogonadal men between 18 and 55 years of age, receiving treatment with NATESTO^® testosterone nasal gel over six months. This study is being conducted at the University of Miami's Department of Urology, and Dr. Ranjith Ramasamy, MD, the Director of Reproductive Urology, is the study's principal investigator. The study is sponsored by Aytu Biosciences - Acerus’ commercialization partner for NATESTO^® in the United States.

“We continue to make significant progress against our core strategic priorities, including continued growth in NATESTO^® sales in Canada as our total prescriptions and total prescription market share hit new highs in October,” said Ed Gudaitis, President and CEO of Acerus Pharmaceuticals. “We also continue to see positive results in ongoing studies with NATESTO^®. These results include the MyT trial, completed earlier this year, which showed that patients demonstrated a preference for NATESTO^® over topical medication. This trial is now followed by the positive interim results in the Spermatogenesis Study, which demonstrated that NATESTO^® may protect and preserve endogenous reproductive hormone secretion. Any testosterone therapy that combines efficacy, convenience, and the potential for preservation of fertility would stand alone as an exciting new option among the existing testosterone therapies”

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’ 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 continued commercial performance of NATESTO^® or the eventual results of R&D initiatives, 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 which 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.

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Ed Gudaitis
President and CEO
Acerus Pharmaceuticals Corporation
[email protected]
(905) 817-8194