Acerus has short­age of 0.5 mg, 1.0 mg doses of Es­trace

Stockwatch Daily - - HEALTH CARE - Mr. Ed Gu­daitis re­ports

ACERUS PHAR­MA­CEU­TI­CALS Corp. has 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.

We seek Safe Har­bor.

Norma Beauchamp, Bo­rys Chabursky, Stephen Robert Gre­gory, Ian Orest Ih­na­towycz, Rolf K Rein­ing­haus, Jef­frey Den­nis Sher­man, Josef Ve­jvoda

(ASP) Shares: 235,354,804

Newspapers in English

Newspapers from Canada

© PressReader. All rights reserved.