Acerus Pharmaceuticals Corporation (TSX:ASP) (the “Company” or “Acerus”) today announced the availability of NATESTOTM, 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)1, in Canada. NATESTOTM is being promoted to healthcare professionals in the major provinces and is now available in the wholesale chain.
In a pivotal Phase III study, NATESTOTM demonstrated statistically significant improvements versus baseline in symptoms associated with hypogonadism, including sexual function and mood as soon as 30 days after initiating treatment. The Phase III findings are suggestive of an excellent safety profile and the product was well tolerated by patients.
NATESTOTM is self-administered via a pocket-sized, travel-friendly nasal dispenser that facilitates rapid, on-the-go, TRT dosing. This novel delivery system will enable men to take their therapy in mere seconds, without worrying about the risks associated with transference of testosterone to women or children. NATESTOTM is also the lowest dose testosterone gel replacement therapy to be approved in Canada.
“The availability of NATESTOTM in Canada is a significant step forward in the treatment of hypogonadism,” stated Dr. Richard Casey, Urologist and Director at The Male Health Centre in Oakville, Ontario. “The unique delivery system of NATESTOTM allows for convenient dosing that fits a man’s lifestyle, as well as relief of symptoms in men diagnosed 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
“This truly is a momentous event for Acerus,” said Tom Rossi, President and Chief Executive Officer of Acerus. “The commercial launch of NATESTOTM in Canada marks a major achievement for our company as it is the first product born from Acerus’ own internal research and development efforts.”
About the NATESTO TM Phase III Study
NATESTOTM 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 NATESTOTM 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 NATESTOTM was low. Prostate-specific antigen (PSA) showed a modest increase, consistent with small increases in dihydrotestosterone (DHT) and DHT/T levels. NATESTOTM was also well tolerated.1
About NATESTO™ (Testosterone) Nasal Gel
NATESTOTM is approved and available in Canada for replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone (hypogonadism). NATESTOTM 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 NATESTOTM in Canada is 11 mg of testosterone (one actuation per nostril) administered twice daily for a total daily dose of 22 mg. A copy of the NATESTOTM product monograph can be found at: http://www.aceruspharma.com/English/products-and-pipeline/natesto/default.aspx.
NATESTOTM is also available in the United States. For further information specific to the U.S. product dosing and administration, please visit: www.NATESTO.com.
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. NATESTOTM, 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. GYNOFLOR™, a product licensed to Acerus in Canada by Medinova AG and approved in 40 countries worldwide, is an ultra-low dose vaginal estrogen therapy with the addition of lactobacillus, for the treatment of atrophic vaginitis, certain vaginal infections and/or to restore a healthy vaginal environment. 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.
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 NATESTOTM, 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 1, 2016 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, December 30, 2015 and Rogol et al. J
Andrology 2015, 4(1), 46.
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.
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Last updated on: 05/10/2016
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