EpiCept Provides Update on Ceplene® Manufacturing at Ben Venue Laboratories Supplies Available for Patients in European Union TARRYTOWN, N.Y.--(BUSINESS WIRE (http://www.businesswire.com/))-- Regulatory News: EpiCept Corporation (Nasdaq OMX Stockholm Exchange and OTCQX: EPCT) today provided an update on the impact of the quality assurance review by the European Medicines Agency (EMA) of Ben Venue Laboratories on the availability of Ceplene®(histamine dihydrochloride). Ben Venue Laboratories, the contract manufacturer of Ceplene®for EpiCept, 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 by the EMA in connection to its findings and no complaints or any other issue relating to product quality have been reported for Ceplene®. As part of its interim recommendations, the EMA’s Committee for Medicinal Products for Human Use (CHMP) noted that it considers supplies of Ceplene®to be essential for patients and that existing stocks in the European Union should remain available to them. Adequate supplies of Ceplene®continue to be available and no immediate shortage is anticipated. As a precaution, and at the direction of the EMA, EpiCept has distributed a Direct Healthcare Professional Communication to all sites where Ceplene®is being used alerting them to strictly follow directions already provided in the Summary of Product Characteristics (SPC) of examining each vial for particulates before use. About EpiCept Corporation EpiCept is focused on the development and commercialization of pharmaceutical products for 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 of relapse in adult patients with AML in first remission. The Company has two other oncology drug candidates currently in clinical development that were discovered using in-house technology and have been shown to act as vascular disruption agents in a variety of solid tumors. The Company's pain portfolio includes AmiKet™, a prescription topical analgesic cream in late-stage clinical development designed to provide effective long-term relief of pain associated with peripheral neuropathies. Forward-Looking Statements This news release and any oral statements made with respect to the information contained in this news release contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include statements which express plans, anticipation, intent, contingency, goals, targets, future development and are otherwise not statements of historical fact. These statements are based on our current expectations and are subject to risks and uncertainties that could cause actual results or developments to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. Factors that may cause actual results or developments to differ materially include: the risks associated with the adequacy of our existing cash resources and our ability to continue as a going concern, the risks associated with our ability to continue to meet our obligations under our existing debt agreements, the risk that Ceplene®will not receive regulatory approval or marketing authorization in the U.S., the risk that Ceplene® will not achieve significant commercial success, the risk that any required post-approval clinical study for Ceplene®will not be successful, the risk that we will not be able to maintain our final regulatory approval or marketing authorization for Ceplene®, the risk that Azixa™ will not receive regulatory approval or achieve significant commercial success, the risk that we will not receive any significant payments under our agreement with Myrexis, the risk that the development of our other apoptosis product candidates will not be successful, the risk that clinical trials for AmiKet™ or crolibulin will not be successful, the risk that AmiKet™ or crolibulin will not receive regulatory approval or achieve significant commercial success, the risk that we will 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 product candidates that appeared promising in early research and clinical trials do not demonstrate safety and/or efficacy in larger-scale or later stage clinical trials, the risk that we will not obtain approval to market any of our product candidates, the risks associated with dependence upon key personnel, the risks associated with reliance on collaborative partners and others for further clinical trials, development, manufacturing and commercialization of our product candidates; the cost, delays and uncertainties associated with our scientific research, product development, clinical trials and regulatory approval process; our history of operating losses since our inception; the highly competitive nature of our business; risks associated with litigation; and risks associated with our ability to protect our intellectual property. These factors and 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 the U.S. Securities and Exchange Commission. You are urged to carefully review and consider the disclosures found in our filings which are available at www.sec.gov (http://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fus. lrd.yahoo.com%2F_ylt%3DAgfqFPfVOEK5M4_Rv8aJvhTjba9_%3B_ylu%3DX3oDMTEzM2pvaWgxBHB vcwMyBHNlYwNuZXdzYXJ0Ym9keQRzbGsDd3d3c2VjZ292%2FSIG%3D15t064n6f%2F**http%253A%2F cts.businesswire.com%2Fct%2FCT%253Fid%3Dsmartlink%2526url%3Dhttp%25253A%25252F%2 5252Fwww.sec.gov%2526esheet%3D6170045%2526lan%3Den_US%2526anchor%3Dwww.sec.gov%2 526index%3D2%2526md5%3D61ec7b72044301e411e3335754ee5c07&esheet=50113130&lan=en-U S&anchor=www.sec.gov&index=1&md5=547d109ab0b47cc6f5669f7122e27375) or at www.epicept.com (http://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2 Fus.lrd.yahoo.com%2F_ylt%3DAhBuoawHw6iS3RhJOH9dNNfjba9_%3B_ylu%3DX3oDMTE2OGhhcWs 4BHBvcwMzBHNlYwNuZXdzYXJ0Ym9keQRzbGsDd3d3ZXBpY2VwdGNv%2FSIG%3D1659oglun%2F**http %253A%2Fcts.businesswire.com%2Fct%2FCT%253Fid%3Dsmartlink%2526url%3Dhttp%25253A% 25252F%25252Fwww.epicept.com%2526esheet%3D6170045%2526lan%3Den_US%2526anchor%3Dw ww.epicept.com%2526index%3D3%2526md5%3D8b3a48c3367e26fcfbd15295b6d82118&esheet=5 0113130&lan=en-US&anchor=www.epicept.com&index=2&md5=b3f4cab99798ee92c3e5adb1f0a 8d49b). You are cautioned not to place undue reliance on any forward-looking statements, any of which could turn out to be wrong due to inaccurate assumptions, unknown risks or uncertainties or other risk factors. *Azixa is a registered trademark of Myrexis, Inc. EPCT-GEN EpiCept Corporation: Robert W. Cook, 914-606-3500 rcook@epicept.com or Media: Feinstein Kean Healthcare Greg Kelley, 617-577-8110 gregory.kelley@fkhealth.com or Investors: LHA Kim Sutton Golodetz, 212-838-3777 kgolodetz@lhai.com or Bruce Voss, 310-691-7100 bvoss@lhai.com
EpiCept Provides Update on Ceplene® Manufacturing at Ben Venue Laboratories
| Source: Immune Pharmaceuticals Inc
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