Acerus Receives Health Canada Approval For NATESTO

TORONTO--(BUSINESS WIRE)--Acerus Pharmaceuticals Corporation (TSX:ASP) today announced the Health Canada approval of NATESTO™, the first and only nasal gel for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone (hypogonadism).¹

“NATESTO™ addresses many of the gaps with current testosterone replacement therapies”

NATESTO™ is the lowest dose testosterone gel replacement therapy to be approved in Canada, with the majority of men achieving normal testosterone levels in a Phase III study. In addition, NATESTO™ demonstrated significant improvements in erectile function, intercourse satisfaction, orgasmic function, sexual desire, overall satisfaction and positive mood versus baseline.

The product utilizes an innovative, bioadhesive nasal gel technology, allowing for convenient, ‘no-touch’ administration within seconds, rapid absorption and reduced risk of secondary transference to women and children. NATESTO™ has a recommended twice-daily starting dose, which can be adjusted up to a three times daily dose if needed.¹

“NATESTO™ addresses many of the gaps with current testosterone replacement therapies,” said Tom Rossi, President and Chief Executive Officer of Acerus. “Health Canada’s approval of NATESTO™ is a momentous event for Acerus, as it represents the opportunity to introduce a unique and novel option for the treatment of men with hypogonadism.”

The prescription testosterone replacement market in Canada represents approximately $70M in sales with stable growth over the past few years. It is estimated that hypogonadism affects approximately 40% of men aged 45 or older², although less than 5% of these men are actually diagnosed and treated for the condition.³

“The approval of a new testosterone nasal gel formulation increases the number of options available for Canadian men with hypogonadism,” stated Dr. Alvaro Morales, Emeritus Professor of Urology, Queen’s University and Chair, Canadian Men’s Health Guidelines Task Force on Testosterone Deficiency. “The low dose of testosterone required, as documented in the multicentre clinical trial conducted in the United States, and the reduced risk of secondary transfer are interesting features of this preparation.”

NATESTO™ is expected to be commercially available in Canada by mid-2016.

About the NATESTO™ Phase III Study

NATESTO™ was evaluated in a multicentre, open-label, 90-day treatment period followed by two sequential safety extension periods of 90 and 180 days that enrolled 306 hypogonadal men, with a mean age of 54 years (range 28-80 years). During the initial treatment period (Days 1-30), 228 patients and 78 patients were treated with 22 mg and 33 mg of testosterone daily, respectively. On Day 45 of the trial, patients were maintained at the same dose or were titrated to three times a day, based on an assessment of 24-hour average serum testosterone concentration. At Day 90, the majority of patients had met the primary endpoint with an average serum total testosterone concentration within the normal range.

Secondary endpoints included assessments of sexual function and mood. Treatment with NATESTO™ produced significant improvements from baseline in erectile function, intercourse satisfaction, orgasmic function, sexual desire and overall satisfaction. In addition, the overall mean summary scores showed a significant increase in positive mood versus baseline.

The incidence of adverse events with NATESTO™ 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. NATESTO™ was well-tolerated and well-accepted.¹

About NATESTO™ (Testosterone) Nasal Gel

NATESTO™ is approved in Canada for replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone (hypogonadism). NATESTO™ is a testosterone nasal gel available in a ‘no-touch’ dispenser with a metered dose pump for reduced transference risk. The recommended starting dose of NATESTO™ in Canada is 11 mg of testosterone (one actuation per nostril) administered intranasally 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.

NATESTO™ is also approved and available in the United States. For further information specific to the U.S. product dosing and administration, please visit: www.NATESTO.com.

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 approved in Canada, and available in the United States for replacement therapy in adult males diagnosed with hypogonadism. TEFINA™, a ‘use as required’ nasal testosterone gel, is an Acerus drug development candidate aimed at addressing a significant unmet need for women with female sexual dysfunction.

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 commercial availability of NATESTO™, 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 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, December 30, 2016.
2. Mulligan T, Frick MF, Zuraw QC, et al. Prevalence of hypogonadism in males aged at least 45 years: The HIM study. Int J Clin Pract 2006;60:762-769.
3. Bebb R. Testosterone deficiency: Practical guidelines for diagnosis and treatment. BCMJ 2011:Vol. 53, No. 9.