Acerus Pharmaceuticals Corporation (TSX: ASP) (Acerus or the
Company) is today advising that it has reported an anticipated
shortage of certain doses of ESTRACE on the Drug Shortages
Canada website in relation to supply issues arising from the Company's
The Company had previously been notified by its contract manufacturer of
a partial manufacturing license suspension at the facility where ESTRACE
is being produced as a result of an audit by U.K. health authorities.
The manufacturer expected that the manufacturing license would be
reinstated by December 2018 in time to avoid delivery delays. The
Company was notified this week that such manufacturing license
reinstatement has not yet occurred and that, as such, the Company's next
expected shipment of ESTRACE may be delayed. This may lead
to potential shortages of the 0.5 mg and 1.0 mg doses of ESTRACE
within the next six months as forecasted demand may exceed in-stock
inventory. At this time, the Company does not foresee a shortfall of the
2.0 mg dose in the next six months based on existing inventory in stock.
The Company is working with the manufacturer to accelerate delivery
timelines, but it is unclear at this time if supply will be
re-established in time to avoid shortages.
We are disappointed that we potentially face a shortfall of supply of
ESTRACE, said Ed Gudaitis, President and CEO of Acerus
Pharmaceuticals. We will be working diligently with all parties to
mitigate the impact of this issue with the goal that a steady supply of
ESTRACE is once again available as soon as possible.
However, should shortages occur or persist, this may have an ongoing
negative impact on ESTRACE revenues.
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 shares trade on TSX under the symbol ASP. For more information,
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Notice Regarding Forward-Looking Statements
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 continued commercial performance of ESTRACE,
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
which is available at www.sedar.com.
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President and CEO
Source: Acerus Pharmaceuticals Corporation