|Acerus Announces Reporting of Anticipated Shortage of ESTRACE®|
|Friday, 11 January 2019 00:06|
Jan. 11, 2019 23:00 UTC
Acerus Announces Reporting of Anticipated Shortage of ESTRACE®
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.”
Notice Regarding Forward-Looking Statements
Source: Acerus Pharmaceuticals Corporation