Acerus Pharmaceuticals Corporation (TSX:ASP) today announced the
signing of an agreement granting Apsen Farmacêutica (Apsen) the
exclusive right to market NATESTO® in Brazil. Apsen is a
leading Brazilian based pharmaceutical company with over 40
products and 1,100 employees in that country.
“We are pleased to be partnering with Apsen, a leading Brazilian
pharmaceutical company, for the commercialization of NATESTO® in
this important market. Apsen has a proven commercial expertise in
the field of urology, and boasts of strong relationships with
specialists and primary care physicians,” said Tricia Symmes, Chief
Operating Officer of Acerus. “Brazil is a large and fast growing
market for pharmaceuticals and partnering with a strong local
player represents another significant step in the worldwide
commercialization of NATESTO, said Luc Mainville, Interim Chief
Executive Officer of Acerus.”
“Apsen values collaborative opportunities in niche, innovative
therapies, and we believe NATESTO® is an important advance for
patients suffering from hypogonadism in Brazil. Its unique nasal
administration, safety and efficacy represent a clear opportunity
to improve patient quality of life in this country,” said Renato
Spallicci, President of Apsen.
Under the terms of the license, development and supply
agreement, Acerus will receive a non-refundable upfront fee, with a
first instalment paid at signing and the remaining payable upon
regulatory approval. Acerus will oversee the manufacturing of
NATESTO® and receive a supply price for the product. If
approved, NATESTO® will be 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) in Brazil.1
About NATESTO® (Testosterone) Nasal Gel
NATESTO® is approved and available in Canada and the United
States for replacement therapy in adult males for conditions
associated with a deficiency or absence of endogenous testosterone
(hypogonadism). NATESTO®’s marketing approval is pending in South
Korea and filings are expect to be made in other jurisdictions over
the course of the coming years. NATESTO® is a testosterone nasal
gel available in a “no-touch” dispenser with a metered dose pump
for reduced transference risk. In Canada, the recommended starting
dose of NATESTO® is 11 mg of testosterone (one actuation per
nostril) administered twice daily for a total daily dose of 22
mg, the lowest topical gel testosterone dose approved in
Canada. A copy of the NATESTO® product monograph can be found at:
http://www.aceruspharma.com/English/products-and-pipeline/natesto/default.aspx.
For information specific to the U.S. product dosing and
administration, please visit: www.NATESTO.com.
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 the patient experience, with a primary focus
in the field of men’s and women’s health.
Acerus currently has two marketed products. ESTRACE®, a product
for the symptomatic relief of menopausal symptoms is commercialized
by Acerus 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
United States. In addition, NATESTO® has been licensed for
distribution in 29 countries worldwide, via the Company’s
international partners. Marketing approvals in those other
jurisdictions would be expected over the course of the coming years
Acerus’ pipeline includes two new innovative products: GYNOFLOR™,
an ultra-low dose vaginal estrogen combined with a probiotic, for
which a NDS has been filed in Canada for the treatment of atrophic
vaginitis, restoration of vaginal flora and treatment of certain
vaginal infections; and TEFINA™, a clinical stage product aimed at
addressing a significant unmet need for women with female sexual
dysfunction.
Acerus’ shares trade on TSX under the symbol ASP. For more
information, visit www.aceruspharma.com and follow us on Twitter
and LinkedIn.
About Apsen
The company was founded in 1969 and is based in São Paulo,
Brazil. Apsen is a 100% Brazilian company owned by the Spallicci
family.
Apsen is engaged in the research and development, manufacture,
and sale of innovative pharmaceutical products in Brazil. It offers
products in the areas of urology, rheumatology, ENT, neurology,
geriatrics, psychiatry, gynecology, gastroenterology, pediatrics,
orthopedics and general medicine.
With a mission to research, develop and deliver innovative
products, Apsen has an ongoing commitment to improve quality of
life and invests in social, cultural and sports activities.
For more information, visit www.apsen.com.br
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 of NATESTO® in Brazil and the
achievement of the milestone payments by Acerus, 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.
References1. NATESTO® Product Monograph, October 25th,
2016 and Rogol et al. J Andrology 2015, 4(1), 46.
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version on businesswire.com: http://www.businesswire.com/news/home/20171123005067/en/
Acerus Pharmaceuticals CorporationTricia Symmes, (416)
509-2116Chief Operating Officertsymmes@aceruspharma.com
Acerus Pharmaceuticals (TSX:ASP)
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