TORONTO--(BUSINESS WIRE)--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 contract manufacturer.
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.”
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’ 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 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
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