Acerus Announces Expansion of NATESTO® Agreement with medac and the Submission of NATESTO® Dossier in Europe
31 Outubro 2018 - 8:00AM
Business Wire
--Amended Agreement Now Covers the Current
EU Member States (including the UK) plus Eight Other
Countries--
Acerus Pharmaceuticals Corporation (TSX: ASP) (“Acerus” or the
“Company”) today announced the signing of an amendment to its
existing licensing and supply agreement with medac Gesellschaft für
klinische Spezialpräparate mbH (“medac”), expanding the German
pharmaceutical company’s exclusive right to market NATESTO® in the
totality of the 28 current EU member countries (including the
United Kingdom) as well as Norway, Liechtenstein, Iceland, Turkey
(including Turkish Cyprus), Australia, New Zealand, Israel and
South Africa. In addition, Acerus is pleased to report that medac
has submitted a dossier for NATESTO® in the first 21 European
Member States under the Decentralised Procedure (DCP) on September
28th, 2018. The original agreement with medac spanned 15 European
countries including Germany, the United Kingdom, France, Spain and
Italy. medac is a German pharmaceutical company with business in
over 80 countries and more than 1,200 employees worldwide.
“With the signing of this amendment Acerus has now secured a
presence for NATESTO® in 71 countries worldwide, supporting our
goal of making NATESTO® a global brand,” said Ed Gudaitis,
President and Chief Executive Officer of Acerus. “Consolidating
NATESTO®’s European commercialization efforts under a single,
experienced partner like medac, should yield meaningful synergies
once sales begin.”
“We are very pleased to announce the expansion of our
partnership with Acerus. This development enables us to provide
patients throughout the EU and beyond with an innovative product”,
said Heiner Will, medac’s Chief Marketing Officer. “With its novel
nasal route of administration”, he added, “NATESTO® is offering an
important advance in improving the quality of life of patients
suffering from hypogonadism.”
Under the terms of the amendment, Acerus will receive an
additional non-refundable one-time upfront fee upon signing.
Pursuant to the terms of the original agreement, Acerus still
expects to receive regulatory milestone payments upon medac
receiving marketing approval in certain countries, as well as
milestone payments based on achieving sales targets. In total,
Acerus is eligible to receive up to €11,000,000 in milestone
payments. Acerus will oversee the manufacturing of NATESTO® and, in
addition, will 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 Europe.1
References
1. NATESTO® Product Monograph, October 25th, 2016 and Rogol et
al. J Andrology 2015, 4(1), 46.
About NATESTO® (Testosterone) Nasal
GelNATESTO® is a nasal gel formulation of testosterone
developed by Acerus Pharmaceutical Corporation and
indicated as a replacement therapy for men diagnosed with
conditions associated with a deficiency or absence of endogenous
testosterone (hypogonadism). It is the first and only
nasally-administered testosterone product approved by the
U.S. FDA, Health Canada and South
Korea and available in a ‘no-touch’ dispenser with a metered
dose pump. A copy of the NATESTO® Canadian product monograph
can be found
at: http://www.aceruspharma.com/English/products-and-pipeline/NATESTO®/default.aspx.
For further information, specific to the U.S. product dosing and
administration, please visit: www.NATESTO®.com.
About AcerusAcerus 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’ 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 StatementsInformation 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 Europe 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 20, 2018 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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Tricia SymmesChief Operating OfficerAcerus Pharmaceuticals
Corporationtsymmes@ceruspharma.com(416) 509-2116
Acerus Pharmaceuticals (TSX:ASP)
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