EPICEPT PROVIDES UPDATE ON CEPLENE® MANUFACTURING AT BEN VENUE LABORATORIES
Dec 21, 2011
OTC Disclosure News Service
Tarrytown, NY –
EpiCeptProvides Update on Ceplene®Manufacturing at Ben Venue Laboratories
SuppliesAvailable for Patients in European Union
TARRYTOWN, N.Y. (December 21, 2011) – EpiCept Corporation (Nasdaq OMX Stockholm Exchangeand OTCQX: EPCT) today provided anupdate on the impact of the quality assurance review by the European MedicinesAgency (EMA) of Ben Venue Laboratories on the availability of Ceplene®(histamine dihydrochloride).
BenVenue Laboratories, the contract manufacturer of Ceplene® forEpiCept, was recently identified by EMA as having “shortcomings in quality assurance” at its facility in Bedford,Ohio. Ceplene® has not been included in the product recall issued bythe EMA in connection to its findings and no complaints or any other issuerelating to product quality have been reported for Ceplene®.
Aspart of its interim recommendations, the EMA’s Committee for Medicinal Productsfor Human Use (CHMP) noted that it considers supplies of Ceplene® tobe essential for patients and that existing stocks in the European Union shouldremain available to them. Adequatesupplies of Ceplene® continue to be available and no immediateshortage is anticipated.
Asa precaution, and at the direction of the EMA, EpiCept has distributed a DirectHealthcare Professional Communication to all sites where Ceplene® isbeing used alerting them to strictly follow directions already provided in theSummary of Product Characteristics (SPC) of examining each vial forparticulates before use.
About EpiCept Corporation
EpiCeptis focused on the development and commercialization of pharmaceutical productsfor the treatment of cancer and pain. The Company’s lead oncology product is Ceplene®, approved in the EU and Israel for the remission maintenance and prevention ofrelapse in adult patients with AML in first remission. The Company has two other oncology drugcandidates currently in clinical development that were discovered using in-housetechnology and have been shown to act as vascular disruption agents in avariety of solid tumors. The Company’s pain portfolio includes AmiKet™, aprescription topical analgesic cream in late-stage clinical developmentdesigned to provide effective long-term relief of pain associated withperipheral neuropathies.
This news releaseand any oral statements made with respect to the information contained in thisnews release contain forward-looking statements within the meaning of thePrivate Securities Litigation Reform Act of 1995. Such forward-lookingstatements include statements which express plans, anticipation, intent,contingency, goals, targets, future development and are otherwise notstatements of historical fact. These statements are based on our currentexpectations and are subject to risks and uncertainties that could cause actualresults or developments to be materially different from historical results orfrom any future results expressed or implied by such forward-lookingstatements. Factors that may cause actual results or developments to differmaterially include: the risks associated with the adequacy of our existing cashresources and our ability to continue as a going concern, the risks associatedwith our ability to continue to meet our obligations under our existing debtagreements, the risk that Ceplene® will not receive regulatoryapproval or marketing authorization in the U.S., the risk that Ceplene® willnot achieve significant commercial success, the risk that any requiredpost-approval clinical study for Ceplene® will not be successful,the risk that we will not be able to maintain our final regulatory approval ormarketing authorization for Ceplene®, the risk that Azixa™ will notreceive regulatory approval or achieve significant commercial success, the riskthat we will not receive any significant payments under our agreement with Myrexis,the risk that the development of our other apoptosis product candidates willnot be successful, the risk that clinical trials for AmiKet™ or crolibulin willnot be successful, the risk that AmiKet™ or crolibulin will not receiveregulatory approval or achieve significant commercial success, the risk that wewill not be able to find a partner to help conduct the Phase III trials for AmiKet™on attractive terms, a timely basis or at all, the risk that our other productcandidates that appeared promising in early research and clinical trials do notdemonstrate safety and/or efficacy in larger-scale or later stage clinicaltrials, the risk that we will not obtain approval to market any of our productcandidates, the risks associated with dependence upon key personnel, the risksassociated with reliance on collaborative partners and others for furtherclinical trials, development, manufacturing and commercialization of ourproduct candidates; the cost, delays and uncertainties associated with ourscientific research, product development, clinical trials and regulatory approvalprocess; our history of operating losses since our inception; the highlycompetitive nature of our business; risks associated with litigation; and risksassociated with our ability to protect our intellectual property. These factorsand other material risks are more fully discussed in our periodic reports,including our reports on Forms 8-K, 10-Q and 10-K and other filings with theU.S. Securities and Exchange Commission. You are urged to carefully review andconsider the disclosures found in our filings which are available at www.sec.govor at www.epicept.com.You are cautioned not to place undue reliance on any forward-lookingstatements, any of which could turn out to be wrong due to inaccurateassumptions, unknown risks or uncertainties or other risk factors.
*Azixa is a registered trademark ofMyrexis, Inc.
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