Healthcare Industry News:  EpiCept 

Biopharmaceuticals Oncology Regulatory

 News Release - May 27, 2008

EpiCept Files Re-Examination Documentation for Marketing Authorization of Ceplene(TM) in Europe

TARRYTOWN, N.Y.--(HSMN NewsFeed)--EpiCept Corporation (Nasdaq and OMX Nordic Exchange: EPCT) today announced that it has submitted the documentation to support a re-examination of its Marketing Authorization Application (MAA) in Europe for Ceplene™ to the Committee for Medicinal Products for Human Use (CHMP). Ceplene (histamine dihydrochloride) is intended for the remission maintenance and prevention of relapse in patients with Acute Myeloid Leukemia (AML) in first remission. The Company anticipates that appeal proceedings in response to this filing will take place in the third quarter of this year.

During the last few months, EpiCept has received new written support from key opinion leaders in hematology representing numerous European countries, who have unanimously recommended the approval of Ceplene in order to have immediate access to this therapy for their patients. “We have met with many of Europe’s leading hematologists and have received overwhelming support for the approval of Ceplene in Europe to address this critical unmet medical need for AML patients,” said Stephane Allard, M.D., Chief Medical Officer of EpiCept.

The comprehensive dossier detailing the grounds for re-examination addresses the three remaining issues that formed the basis of the negative opinion issued by the CHMP on March 19, 2008. EpiCept believes that this dossier supplies ample and compelling evidence for the approval of the MAA for Ceplene, and through this submission affirms to regulators that the MAA submitted:
  • Provides a clear and strong pharmacological rationale for the use of Ceplene in conjunction with low dose interleukin-2 in this indication. Updated clinical pharmacological data have been added, which supplement the original MAA and are supported by rigorous and well-documented preclinical in vitro and in vivo studies, published in leading scientific journals.
  • Includes updated data from our prior clinical trials that support Ceplene’s pharmacologic rationale and mechanism of action. The data from the Phase III study have already clearly demonstrated the significant efficacy and the excellent safety of Ceplene in this indication;
  • Presents statistically significant results through the inclusion of positive data from Ceplene’s Phase II study and pivotal Phase III study. These data have undergone another independent statistical analysis performed by leading European biostatisticians who have validated the original analyses and have confirmed that the data are robust and that the results cannot be explained by chance.
The Company also submitted in the dossier a signed consensus statement from leading European AML experts from each of the major European countries acknowledging the critical medical need for a safe and effective remission maintenance therapy for AML patients and that Ceplene when approved would be used in hematology clinical practice for this disease. In addition, we submitted a signed consensus statement from leading European biostatisticians attesting to the consistency and robustness of the Phase III Ceplene data package.

“The approval of Ceplene, in conjunction with IL-2, would provide AML patients in Europe with the first pharmaceutical therapy to produce a clear benefit in prolonging leukemia free survival and preventing relapse. Furthermore it is expected that an approval would prevent relapse of this disease in nearly 1500 patients per year in Europe, patients who have no other therapeutic alternative,” remarked Jack Talley, President and CEO of EpiCept. “We believe we have completely addressed the concerns of the CHMP and are hopeful that the CHMP appreciates the benefit-to-risk balance of Ceplene and grants a marketing authorization for this important product.”

About Acute Myeloid Leukemia (AML)

AML is the most common type of leukemia in adults. There are approximately 40,000 AML patients in the EU, with 16,000 new cases occurring each year. Once diagnosed with AML, patients are typically treated with induction chemotherapy and consolidation therapy, with the majority achieving complete remission. However, about 75-80% of patients who achieve first remission will relapse, with the median time in remission before relapse being only 12 months with current treatments. Less than 5% of relapsed patients survive long term.

About Ceplene

Ceplene is EpiCept's registration-stage compound for the treatment of AML. Ceplene is designed to protect lymphocytes responsible for immune-mediated destruction of residual leukemic cells. Laboratory research has demonstrated that Ceplene reduces formation of oxygen radicals from phagocytes, inhibiting NADPH oxidase and protecting IL-2-activated NK-cells and T-cells.

About EpiCept Corporation

EpiCept is focused on unmet needs in the treatment of cancer and pain. The Company’s broad portfolio of pharmaceutical product candidates includes several pain therapies in clinical development and a lead oncology compound for AML with demonstrated efficacy in a Phase III trial; a marketing authorization application for this compound recently received a negative opinion and is being re-examined in Europe. In addition, EpiCept’s ASAP technology, a proprietary live cell high-throughput caspase-3 screening technology, can efficiently identify new cancer drug candidates and molecular targets that selectively induce apoptosis in cancer cells. Two oncology drug candidates currently in clinical development that were discovered using this technology have also been shown to act as vascular disruption agents in a variety of solid tumors.

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 EpiCept's 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 our appeal of the negative opinion regarding the MAA for Ceplene® will not be successful and that Ceplene® will not receive regulatory approval or marketing authorization in the EU, the risk that Ceplene®, if approved, will not achieve significant commercial success, the risks associated with the adequacy of our existing cash resources and our need to raise additional financing to continue to meet our capital needs 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 or that we may default on our loans or that our lenders may declare the Company in default or that our secured lender would seek to sell our assets, the risks that we may not be able to extend the maturity of our euro-denominated loan, the risk that the Company's 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 our ASAP technology will not yield any successful product candidates, the risk that clinical trials for NP-1 or EPC2407 will not be successful, the risk that NP-1 or EPC2407 will not receive regulatory approval or achieve significant commercial success, 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 EpiCept's periodic reports, including its 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 EpiCept's 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.

*Azixa is a registered trademark of Myriad Genetics, Inc.


Source: EpiCept

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