Acerus Announces NATESTO Publication In Prominent Andrology Journal

TORONTO--(BUSINESS WIRE)--Acerus Pharmaceuticals Corporation (TSX:ASP) today announced that NATESTO™ will be featured in the January 2016 issue of Andrology, the official journal of the American Society of Andrology and the European Academy of Andrology. The article, entitled “NATESTO™, a novel testosterone nasal gel, normalizes androgen levels in hypogonadal men,” highlights the positive results of the randomized, open-label, dose-ranging Phase III study and safety extension. An online version of the abstract is currently available at: http://onlinelibrary.wiley.com/doi/10.1111/andr.12137/abstract.

“NATESTO™, a novel testosterone nasal gel, normalizes androgen levels in hypogonadal men”

“NATESTO™ fulfills an important unmet need in the testosterone replacement therapy space,” said Alan D. Rogol, MD, Ph.D. Professor, Emeritus at the University of Virginia, and lead author of the publication. “We know from research that ease of administration, low testosterone dose, and reduced risk of secondary transference are important features to physicians and their patients, which NATESTO™ offers.”

“We are extremely pleased that NATESTO™, a product proudly developed in Canada, is featured in such a prominent journal as Andrology,” said Tom Rossi, President and Chief Executive Officer of Acerus. “We look forward to making this innovative therapy available to even more men with hypogonadism this year.”

About the Phase III Study

NATESTO™ was evaluated in a one year, multicenter, randomized, open-label Phase III study, including potential dose titration. The study enrolled 306 hypogonadal men, with a mean age of 54 years (range 28-80 years). Patients were provided NATESTO™ and administered per instruction, with 228 patients and 78 patients treated with 22 mg and 33 mg of testosterone daily, respectively. At Day 90, 200/273 subjects (73%; 95% CI 68-79) in the intent-to-treat (ITT) population and 180/237 subjects (76%; 95% CI 71-81) in the per-protocol (PP) population were in the normal range. In the group treated only with 33 mg, ninety percent (90%) had average concentration (Cavg) within the normal range (300 to 1050 ng/dL) on Day 90; the percentage of patients with Cavg below the normal range (less than 300 ng/dL) on Day 90 was 10% and no subject had a Cavg value exceeding 1050 ng/dL. Statistically significant improvements from baseline were observed in erectile function and mood. The incidence of adverse events was low. Prostate-specific antigen (PSA) showed a modest increase, consistent with small increases in dihydrotestosterone (DHT) and DHT/T levels. All of these findings are suggestive of an excellent safety profile. Therapy was well-tolerated and well-accepted.

Additionally, in a post-study survey, patients treated with NATESTO™ reported that they were confident about administering the product within two days of starting treatment, and nearly 70% of those previously treated with another testosterone replacement therapy stated they would switch to NATESTO™.

About NATESTO™ (Testosterone) Nasal Gel

NATESTO™ is the first and only testosterone nasal gel to be approved and launched in the United States for replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone. For further information on NATESTO™ in the United States (including the product label and prescribing information), please see the FDA website at: http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm, or visit: www.NATESTO.com.

Acerus has filed a New Drug Submission with Health Canada for NATESTO™, and the product is currently under review.

About Acerus

Acerus Pharmaceuticals Corporation is a Canadian pharmaceutical company focused on the development, manufacture, marketing and distribution of innovative, branded products that improve the patient experience.

Acerus markets ESTRACE^® in Canada, a product indicated for the symptomatic relief of menopausal symptoms. NATESTO™, a product utilizing an Acerus licensed nasal gel technology, is the first and only testosterone nasal gel available in the United States for replacement therapy in adult males diagnosed with hypogonadism. It is also currently filed for approval in Canada. TEFINA™, a ‘use as required’ nasal testosterone gel, is an Acerus drug development candidate aimed at addressing significant unmet need for women with female sexual dysfunction.

For more information, visit www.aceruspharma.com and follow us on Twitter and LinkedIn.

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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 4, 2015 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.