TORONTO--(BUSINESS WIRE)--
Acerus Pharmaceuticals Corporation (TSX:ASP) (“Acerus” or the “Company”)
today announced that it has received a Notice of Deficiency (“NOD”) for
its GynoflorTM New Drug Submission.
In its notice, Health Canada requested additional technical information
on GynoflorTM in order to complete its assessment of the
product, which the Company believes will cause a delay in the review
process.
“Such requests are not unusual during the regulatory review”, said Luc
Mainville, Interim Chief Executive Officer of Acerus. “Gynoflor™ is
approved in 41 countries across Europe, Asia-Pacific, the Middle East,
Africa and South America, and it is estimated that up to 32.7 million
women worldwide have been treated with the product to date. We look
forward to working with Health Canada to bring this important treatment
option to Canadian patients as expeditiously as possible”.
About Acerus
Acerus Pharmaceuticals Corporation is a Canadian-based specialty
pharmaceutical company focused on the development, manufacture,
marketing and distribution of innovative, branded products that improve
patient experience, with a primary focus in the field of men’s and
women’s health. The Company commercializes its products via its own
salesforce in Canada, and through a global network of licensed
distributors in the U.S. and other territories.
Acerus currently has two marketed products. ESTRACE®, a product for the
symptomatic relief of menopausal symptoms, is commercialized in Canada;
and NATESTO®, the first and only testosterone nasal gel for testosterone
replacement therapy in adult males diagnosed with hypogonadism, is
commercialized in Canada and the U.S. In addition, NATESTO® has been
licensed for distribution in 30 countries worldwide. Marketing approvals
in jurisdictions outside of North America are expected to take place
over the course of the coming years. Acerus’ pipeline includes three
innovative product lines: GYNOFLOR™, an ultra-low dose vaginal estrogen
combined with a probiotic, for which a NDS has been filed in Canada for
the treatment of vaginal atrophy, restoration of vaginal flora and
treatment of certain vaginal infections; TEFINA™, a clinical stage
product aimed at addressing a significant unmet need for women with
female sexual dysfunction; and ELEGANTTM, a franchise
comprised of Elegant™ Vaginal Moisturizer, which provides comfort to
women suffering from vaginal dryness, and Elegant™ pH, which is a pH
balanced vaginal product. Finally, the Company owns or has a license to
numerous patents relating to proprietary delivery systems as well as
novel formulations of products currently in the early stage of
development.
Acerus’ shares trade on TSX under the symbol ASP. For more information,
visit www.aceruspharma.com
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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 regulatory approval and
potential commercial success of GynoflorTM in Canada, 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 7, 2017 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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Source: Acerus Pharmaceuticals Corporation