02.06.2009 04:01:00
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EpiCept Partners With IDIS For Ceplene® Named Patient/Compassionate Use Program
Regulatory News:
EpiCept Corporation (Nasdaq and OMX Nordic Exchange: EPCT) today announced that it has signed an agreement with IDIS, a private, U.K.-based company, to administer a Named Patient Program for Ceplene®, EpiCept’s proprietary therapy approved in the European Union for the remission maintenance and prevention of relapse of patients with Acute Myeloid Leukemia (AML) in first remission. Under this agreement, Ceplene is now available on a named patient basis in Europe in advance of its commercial launch later this year, as well as in the key worldwide markets including South America, Japan, Australia, Israel and Canada.
"We are excited to partner with a recognized leader in named patient programs, and to launch patient access to Ceplene in these global markets,” remarked Jack Talley, President and CEO of EpiCept. "This agreement provides EpiCept with near-term product revenue and the opportunity for physician engagement and education on the proper use and administration of the drug while we continue our thorough selection process for a commercial partner for Ceplene in Europe. Importantly, the agreement will provide AML patients in these markets with access to the first therapy demonstrated to prevent relapse in this devastating disease.”
A named patient program is a compassionate use drug supply program through which physicians can prescribe patients with investigational or approved drugs prior to their commercial launch through a legal and ethical channel. Under the terms of the agreement, IDIS will be the exclusive worldwide supplier of the named patient program administration of Ceplene. Under this program Ceplene will be available in all major markets worldwide except the United States.
In support of the Named Patient Program for Ceplene, EpiCept will have a full scientific, medical and commercial presence at the 14th Annual Meeting of the European Hematology Association, to be held June 4-7, 2009 in Berlin, Germany.
About Ceplene®
Ceplene® is EpiCept's proprietary product approved in the European Union for maintenance therapy for adult patients with AML in first remission. 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. In October 2008, Ceplene ®received full marketing approval in the European Union for maintenance therapy and prevention of relapse in adult patients with AML in first remission.
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 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.
About IDIS
IDIS is the world leader in the development and implementation of Named Patient Programs and has a proven track record of working in strategic partnership with U.S.-based companies to bring new medicines to Europe for the first time. IDIS supports its customers in over 100 countries worldwide, supplying more than 400 different medicines per month and responding to more than half a million requests on a named-patient basis to medical professionals worldwide. Headquartered near central London, IDIS has been a strategic partner to more than 40 pharmaceutical and biotech companies. For more information on IDIS, please visit the website www.idispharma.com or contact John Lagus at NPP@idispharma.com.
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 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 risk that we will not have sufficient authorized shares of stock to raise equity capital, 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 or the OMX Nordic Exchange and that any appeal of the delisting determination may not be successful, the risk that Ceplene® will not receive regulatory approval or marketing authorization in the United States or Canada, 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 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.
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