Acerus Files a New Drug Submission for GYNOFLOR™ in Canada
01 Março 2017 - 9:30AM
Business Wire
Acerus Pharmaceuticals Corporation (TSX:ASP) today announced
that it has filed a New Drug Submission (NDS) for GYNOFLOR™ with
Health Canada. GYNOFLOR™ is an ultra-low dose estrogen (estriol)
and probiotic (Lactobacillus acidophilus) combination vaginal
tablet used for the treatment of symptoms of vaginal atrophy, for
the restoration of vaginal flora following the use of
anti-infectives and for the treatment of certain vaginal
infections. In the NDS filed today, Acerus is seeking approval from
Health Canada for similar indications.
“The filing of this NDS further demonstrates our commitment to
expanding our women’s health portfolio and to providing innovative
treatment options to Canadian,” said Tom Rossi, President and Chief
Executive Officer of Acerus. “GYNOFLOR™ is a highly-differentiated
product which, if approved, has the potential to help the many
women who suffer from vaginal atrophy and certain vaginal
infections, and contribute significant revenues to our Canadian
business. We look forward to working with Health Canada and
bringing GYNOFLOR™ to the Canadian market.”
About GYNOFLOR™
GYNOFLOR™ is an ultra-low dose estrogen (estriol) and probiotic
(Lactobacillus acidophilus) combination vaginal tablet used for the
treatment of symptoms of vaginal atrophy due to estrogen deficiency
during menopause and post-menopause, for the restoration of vaginal
flora following the use of anti-infectives and for the treatment of
certain vaginal infections. 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.
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’ shares trade on TSX under the symbol
ASP. 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 ability of Acerus to obtain regulatory approval for
GYNOFLOR™, 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 which 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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version on businesswire.com: http://www.businesswire.com/news/home/20170301005610/en/
Acerus Pharmaceuticals CorporationTricia Symmes,
289-327-1499Chief Operating Officertsymmes@aceruspharma.com
Acerus Pharmaceuticals (TSX:ASP)
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