EpiCept Corporation Announces Health Canada Accepts Ceplene[R] Application for Review.Marketing Application Also Accepted in Israel
TARRYTOWN, N.Y. -- Regulatory News:
EpiCept Corporation (Nasdaq and OMX OMX Office Max (stock symbol) Nordic Exchange: EPCT EPCT Engineering, Procurement, Construction, Turnkey ) today announced that Health Canada Health Canada (French: Santé Canada) is the department of the government of Canada with responsibility for national public health.
Health Canada's goal is to improve Canadian life by improving Canadian longevity, lifestyle and use of public healthcare. has accepted for review the Company's New Drug Submission (NDS See eDirectory.
NDS - Netware Directory Services ) for Ceplene([R]) (histamine dihydrochloride) for the remission maintenance of acute myeloid leukemia myeloid leukemia
See myelogenous leukemia. (AML AML - A Manufacturing Language ) patients in first complete remission complete remission Complete response Oncology Disappearance of all signs and symptoms of disease–eg, cancer, multiple sclerosis, with normalization of all biochemical and radiologic parameters, as well as a negative repeat biopsy–pathologic remission. . Health Canada's performance target for the completion of review and a decision is within 300 days.
"We are pleased to have completed another key milestone in our North American North American
named after North America.
North American blastomycosis
see North American blastomycosis.
North American cattle tick
see boophilusannulatus. regulatory strategy for Ceplene([R])," stated Jack Talley, President and Chief Executive Officer of EpiCept. "As the next step in this process, we are focused on the filing of a New Drug Application for Ceplene([R])with the U.S. Food and Drug Administration for AML remission maintenance. As previously stated, we intend to utilize the approval of Ceplene([R]) in order to establish a fully integrated specialty pharmaceutical company focused in hematology in North America North America, third largest continent (1990 est. pop. 365,000,000), c.9,400,000 sq mi (24,346,000 sq km), the northern of the two continents of the Western Hemisphere. ."
EpiCept also announced today that Israel's Ministry of Health has accepted a marketing application for Ceplene([R]) for the remission maintenance of AML patients in first remission. The Company's distribution and marketing partner for Ceplene([R]) in Israel, Megapharm Ltd., filed the application and will market Ceplene([R]) upon approval. A decision on this application is anticipated late next year.
Ceplene([R])is approved in the European Union European Union (EU), name given since the ratification (Nov., 1993) of the Treaty of European Union, or Maastricht Treaty, to the
European Community for the remission maintenance and prevention of relapse in patients with AML in first remission. The company is continuing negotiations with prospective partners for the European marketing rights to Ceplene([R]). In June 2009 EpiCept launched a named patient program for Ceplene([R])in partnership with IDIS IDIS Intelligent Driver Information System (Volvo)
IDIS International Dismantling Information System (automotive recycling)
IDIS Iowa Drug Information Service
IDIS Integrated Disbursement Information System under which physicians in all major global markets excluding the U.S. can prescribe Ceplene([R]).
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 European Commission, branch of the governing body of the European Union (EU) invested with executive and some legislative powers. Located in Brussels, Belgium, it was founded in 1967 when the three treaty organizations comprising what was then the European Community for the remission maintenance and prevention of relapse in adult patients with 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[TM] NP-1, a prescription topical analgesic analgesic (ăn'əljē`zĭk), any of a diverse group of drugs used to relieve pain. Analgesic drugs include the nonsteroidal anti-inflammatory drugs (NSAIDs) such as the salicylates, narcotic drugs such as morphine, and synthetic drugs 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, contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and 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 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 Originally called the NASDAQ Small Cap Market, NASDAQ announced a name change to the NASDAQ Capital Market on September 27, 2005. 
The NASDAQ Capital Market exists for securities of smaller, less-capitalized companies (small caps) that do not qualify for and that any appeal of the delisting determination may not be successful, the risk that Myriad's development of Azixa[TM] will not be successful, the risk that Azixa[TM] 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 (chat) asap - As soon as possible. technology, the risk that clinical trials for EpiCept(TM) NP-1 or crinobulin will not be successful, the risk that EpiCept[TM] 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[TM] 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 An action brought in court to enforce a particular right. The act or process of bringing a lawsuit in and of itself; a judicial contest; any dispute.
When a person begins a civil lawsuit, the person enters into a process called 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.
*Azixa is a registered trademark of Myriad Genetics, Inc.