Acerus Announces Canadian Commercial Launch of NATESTOTM

Acerus Pharmaceuticals Corporation (TSX:ASP) (the “Company” or “Acerus”) today announced the availability of NATESTO^TM, 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. NATESTO^TM is being promoted to healthcare professionals in the major provinces and is now available in the wholesale chain.
In a pivotal Phase III study, NATESTO^TM 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.
NATESTO^TM 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. NATESTO^TM
is also the lowest dose testosterone gel replacement therapy to be
approved in Canada.
“The availability of NATESTO^TM 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 NATESTO^TM 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 NATESTO^TM
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
NATESTO^TM 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^TM 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^TM was low.
Prostate-specific antigen (PSA) showed a modest increase, consistent
with small increases in dihydrotestosterone (DHT) and DHT/T levels.
NATESTO^TM was also well tolerated.¹
About NATESTO™ (Testosterone) Nasal Gel
NATESTO^TM is approved and available in Canada for replacement
therapy in adult males for conditions associated with a deficiency or
absence of endogenous testosterone (hypogonadism). NATESTO^TM
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^TM 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 NATESTO^TM product monograph can
be found at: https://www.aceruspharma.com/English/products-and-pipeline/natesto/default.aspx.
NATESTO^TM is also 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^TM, 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.
For more information, visit www.aceruspharma.com
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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 NATESTO^TM, 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.
References:
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.