OREANDA-NEWS. June 20, 2016. Acerus Pharmaceuticals Corporation (TSX:ASP) today announced that an
abstract highlighting the therapeutic potential of NATESTO(TM), a novel
testosterone nasal gel, will be featured at the 71st Annual
Canadian Urological Association Meeting in Vancouver, British Columbia
on Monday, June 27th, 2016.
The abstract, entitled "Novel Nasal Gel Restores Testosterone Levels
in Hypogonadal Men with Seasonal Allergies," will be presented by
Alan D. Rogol, MD, Ph.D. Professor, Emeritus at the University of
Virginia.
"We are very excited to officially introduce NATESTO(TM) to Canadian
urologists and other healthcare practitioners at the upcoming Canadian
Urological Association Meeting," said
Tom Rossi, President and Chief
Executive Officer of Acerus. "Our participation at the meeting signifies
the first of many steps we will take in building our partnership and
presence within the urology community in Canada. We look forward to
making this innovative product available to Canadian men with low
testosterone within the next months."
The abstract summarizes the efficacy results seen in patients with
seasonal allergies who were included in clinical studies supporting the
approval of NATESTO(TM) in the U.S. and Canada. The Phase 1 pharmacokinetic
study demonstrated that the absorption and efficacy of NATESTO(TM)testosterone
nasal gel is maintained even when patients with seasonal allergies
(rhinitis) are forcibly challenged with pollen from Dactylis glomerata.
The concomitant use of a decongestant (oxymetazoline) after the pollen
challenge did not modify the absorption of testosterone. In the pivotal
Phase 3 study, only three out of a total of 52 subjects with seasonal
allergies and treated with NATESTO(TM) for six months or more, reported
seasonal allergic flare-ups. The surprisingly low incidence of seasonal
allergies in the Phase 3 study is believed to reflect the unique
formulation, which includes a natural oil that may create a fine
protective barrier to reduce the direct contact of air-born allergens
with the nasal mucosa and thereby reduce allergy flare-up.
About NATESTO(TM)
NATESTO(TM) was approved by Health Canada in January 2016 for replacement
therapy in adult males for conditions associated with a deficiency or
absence of endogenous testosterone (hypogonadism). Commercial
availability of NATESTO(TM) in Canada is expected in the third quarter of
this year.
For more information about NATESTO(TM), please consult the Product
Monograph at: http://s2.q4cdn.com/417379002/files/doc_downloads/NATESTO-PM-December-30-2015.pdf.
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(R) 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(TM), a product licensed to Acerus in Canada by
Medinova AG and approved in 39 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(TM), 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 the performance of 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.
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