Healthcare Industry News: NP-1
News Release - December 21, 2010
EpiCept Announces Ceplene(R) Approved for Marketing in IsraelAdditional Marketing Approval Applications Anticipated in 2011
TARRYTOWN, N.Y.--(Healthcare Sales & Marketing Network)-- EpiCept Corporation (Nasdaq and Nasdaq OMX Stockholm Exchange: EPCT) today announced that the Israeli Ministry of Health has approved the marketing application for Ceplene®, indicated for remission maintenance and prevention of relapse in adult patients with Acute Myeloid Leukemia (AML) in first remission. Megapharm Ltd. is EpiCept’s partner in Israel and upon Ministry of Health approval of labeling and other technical matters the company is expected to launch Ceplene® in the first quarter of 2011.
EpiCept also anticipates that new marketing applications for Ceplene® will be filed in several non-EU European and Pacific Rim countries in early 2011 by its marketing partner Meda AB.
Jack Talley, EpiCept President and CEO commented: “We are delighted that with this approval doctors in Israel will be able to prescribe Ceplene® for their patients who are in first AML remission. Some of these doctors have worked with us for many years to help obtain marketing approval in the European Union, so we are especially gratified that their efforts will allow them to use Ceplene® in their own medical practices. We also look forward to further expanding the number of countries in which Ceplene® is available through the new marketing applications expected to be filed by Meda next year.”
Ceplene® is approved in the European Union and is indicated for remission maintenance therapy and prevention of relapse in adult patients with Acute Myeloid Leukemia (AML), one of four types of leukemia. Ceplene® is used together with low dose Interleukin-2. The prevalence for AML in the EU is about 41,000 patients and over 16,000 new cases are diagnosed every year. While current induction and consolidation treatments are successful in inducing complete remission for the majority of AML patients, this remission is generally short-lived. After achieving complete remission most patients will suffer a relapse within one year. In an international, multicenter, open-label, randomized Phase III study, Ceplene® met its primary endpoint of prolonging leukemia-free survival for AML patients in remission. The difference between the treated and control group was highly statistically significant (p<0.008). A recently-completed subset analysis of patients that were treated aggressively with consolidation therapy before being randomized into the Phase III trial demonstrated a difference in overall patient survival in favor of Ceplene®/IL-2 versus standard of care (p-value = 0.07, with a median overall benefit of 36 months), suggesting that statistically significant improved overall survival could be achieved in an adequately powered clinical trial.
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®, approved in the EU for the remission maintenance and prevention of relapse in adult patients with Acute Myeloid Leukemia (AML) in first remission. In the U.S., a pivotal trial is scheduled to commence in 2011. 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 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.
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 that 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, 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 future financing will not successfully close or that the proceeds thereof will be materially less than anticipated, 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 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 EpiCept™ NP-1 or crolibulinTM will not be successful, the risk that EpiCept™ NP-1 or crolibulinTM 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; the risk that our securities may be delisted from Nasdaq; 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.
*Azixa is a registered trademark of Myrexis, Inc.
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