03.09.2009 04:01:00
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EpiCept’s Ceplene® Highlighted in Two 2008 European Union Drug Approval Reports
Regulatory News:
EpiCept Corporation (Nasdaq and OMX Nordic Exchange: EPCT) today announced that Ceplene® (histamine dihydrochloride) has been highlighted in two separate reports issued recently reviewing 2008 drug approvals in the European Union. One report, issued by the U.K. publication Mednous, said that Ceplene® was one of 12 products "expected to confer major public health benefits,” while the European Medicines Agency (EMEA), in its summary of the annual report for 2008, stated, "Of the 66 medicines to receive a positive opinion from the CHMP in 2008, those that are of particular note include: the first medicine for use as a maintenance treatment in adults with acute myeloid leukemia…”
"We are gratified that Ceplene® has been recognized for its importance in providing a clear benefit in prolonging leukemia-free survival and preventing relapse among AML patients in first remission,” stated Jack Talley, President and Chief Executive Officer of EpiCept. "We believe that Ceplene® is poised to make a major contribution to the management of this deadly disease. As such, we are making it available on a named patient basis essentially worldwide, with the exception of the United States. In the United States we are continuing our preparation of a New Drug Application or NDA for submission to the FDA."
Ceplene® is approved in the European Union for the remission maintenance and prevention of relapse in patients with AML in first remission. The company is continuing negotiations with several prospective partners for the European marketing rights to Ceplene®. In June 2009 EpiCept launched a named patient program for Ceplene® in partnership with IDIS under which physicians in all major global markets excluding the U.S. can prescribe Ceplene®.
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 product is Ceplene®, which has been granted full marketing authorization by the European Commission for the remission maintenance and prevention of relapse in adult patients with Acute Myeloid Leukemia (AML) in first remission. The Company has two 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 EpiCept™ NP-1, 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, contains 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 risk that Ceplene® will not receive regulatory approval or marketing authorization in the United States or Canada, the risk that Ceplene® will not be launched in Europe in the second half of 2009 or achieve significant commercial success, the risk that we are unable to find a suitable marketing partner for Ceplene® on attractive terms, a timely basis or at all, 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 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 our securities may be delisted by The Nasdaq Capital Market and that any appeal of the delisting determination may not be successful, , the risk that Myriad's development of Azixa™ will not be successful, 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 Myriad, the risk that the development of our other apoptosis product candidates will not be successful, the risk that we will not be able to find a buyer for our ASAP technology, the risk that clinical trials for EpiCeptTM NP-1 or crinobulin will not be successful, the risk that EpiCept™ NP-1 or crinobulin 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 EpiCept™ NP-1 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 or at www.epicept.com. 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.
EPCT-GEN
*Azixa is a registered trademark of Myriad Genetics, Inc.
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