Healthcare Industry News: Ceplene
News Release - April 19, 2010
EpiCept Announces Commercial Launch of Ceplene(R) in the United KingdomTARRYTOWN, N.Y., April 19--(HSMN NewsFeed)--EpiCept Corporation (Nasdaq and Nasdaq OMX Stockholm Exchange: EPCT) today announced that the commercial launch of Ceplene® (histamine dihydrochloride) will take place in the United Kingdom on April 20, 2010 in conjunction with the British Society for Haematology 50th Annual Scientific Meeting in Edinburgh, Scotland. Ceplene is approved in the European Union for the remission maintenance and prevention of relapse in patients with Acute Myeloid Leukemia (AML) in first remission. The launch is being conducted by Meda AB, (OMX Nordic Exchange: MEDA-A-ST) as part of an exclusive commercialization agreement for Ceplene signed by the two companies in January 2010. Meda is a leading international specialty pharmaceutical company with products sold in 120 countries worldwide and a marketing organization of about 1,200 people throughout Europe.
“We are very pleased that Ceplene will soon be readily available to clinicians in the U.K. and that patients will be able to reap the benefits of the only immunomodulator proven to show a clear benefit in prolonging leukemia-free survival and preventing relapse in AML patients,” said Jack Talley, president and chief executive officer of EpiCept. “We look forward to working closely with Meda for the drug’s next expected launch in Germany, and ultimately throughout Europe.”
In support of the commercial launch for Ceplene, Meda will be holding a Satellite Symposium session on Tuesday, April 20, 2010 at the aforementioned scientific meeting. The session, entitled “Maintaining Remission in AML – The Challenge,” will be co-chaired by Dr. Alan K. Burnett and Dr. Jonathen Kell. Dr. Burnett is a Professor in the Department of Haemotology in the School of Medicine at Cardiff University in Cardiff, Wales and chairman of the collaborative group of the Medical Research Council in the U.K. Dr. Kell is a professor at Cardiff University’s School of Medicine, Department of Haemotology. Meda is expected to begin shipping Ceplene to clinicians at the end of April.
Ceplene is indicated for remission maintenance therapy and prevention of relapse in adult patients with Acute Myeloid Leukemia (AML). Ceplene is used together with low dose Interleukin-2. AML is one of four major types of leukemia. Approximately 16,000 new cases of AML are diagnosed in Europe 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 statistically significant (p<0.008).
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 (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™ 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 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 receive regulatory approval or marketing authorization in the United States or Canada, the risk that Ceplene® will not be launched or 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 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 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 crolibulin™ will not be successful, the risk that EpiCept NP-1 or crolibulin™ 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; 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.
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