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TARRYTOWN, N.Y., Aug 05, 2009 (BUSINESS WIRE) -- Regulatory News:
EpiCept Corporation (Nasdaq and OMX Nordic Exchange: EPCT) today announced that it has filed a New Drug Submission (NDS) with Health Canada for Ceplene(R) (histamine dihydrochloride) for the treatment of acute myeloid leukemia (AML) patients in first complete remission. Health Canada typically accepts or refuses an NDS and designates review status within forty-five days of filing. If accepted, the customary timeframe for completion of review and an approval decision is within one year.
"The filing of the NDS for Ceplene(R) with Health Canada is a another key milestone for EpiCept and an important step in our North American regulatory strategy for this innovative new therapy," stated Jack Talley, President and Chief Executive Officer of EpiCept. "We anticipate that we will also be in the position to file a New Drug Application with the U.S. Food and Drug Administration towards the end of this year, contingent upon planned discussions with the FDA."
Ceplene(R) is currently 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(R). In June 2009, EpiCept announced that it had launched a named patient program for Ceplene(R) in partnership with IDIS and under which physicians in all major global markets excluding the U.S. can prescribe Ceplene(R) to patients.
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(R), 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 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 EpiCeptTM 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(R) will not receive regulatory approval or marketing authorization in the United States or Canada, the risk that Ceplene(R) 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(R) on attractive terms, a timely basis or at all, the risk that any required post-approval clinical study for Ceplene(R) will not be successful, the risk that we will not be able to maintain our final regulatory approval or marketing authorization for Ceplene(R), 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 AzixaTM will not be successful, the risk that AzixaTM 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 EpiCeptTM 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 EpiCeptTM 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.
SOURCE: EpiCept Corporation
EpiCept Corporation:
Robert W. Cook, 914-606-3500
mail@epicept.com
or
Media:
Feinstein Kean Healthcare
Greg Kelley, 617-577-8110
gregory.kelley@fkhealth.com
or
Investors:
Lippert/Heilshorn & Associates
Kim Sutton Golodetz, 212-838-3777
kgolodetz@lhai.com
or
Bruce Voss, 310-691-7100
bvoss@lhai.com
Copyright Business Wire 2009