TARRYTOWN, N.Y.--(BUSINESS WIRE)--Regulatory News:
EpiCept Corporation (Nasdaq and OMX Nordic Exchange: EPCT) announced today that it has entered into an exclusive commercialization agreement for Ceplene® (histamine dihydrochloride) with Meda AB, (OMX Nordic Exchange: MEDA-A-ST) a leading international specialty pharmaceutical company based in Stockholm. Ceplene is EpiCept’s novel therapy approved in the European Union with orphan drug status for the remission maintenance and prevention of relapse of patients with acute myeloid leukemia (AML) in first remission.
Meda is a leading international specialty pharmaceutical company with products sold in 120 countries worldwide. The company has its own sales organizations in the U.S. and more than 40 other countries, including a marketing organization of about 1,200 people throughout Europe. Meda’s annual sales is currently approximately $1.8 billion with several products in the cancer area, including Onsolis®, indicated for breakthrough pain in cancer patients.
Under the terms of the agreement, EpiCept will grant Meda the right to market Ceplene in Europe and several other countries including Japan, China, and Australia. EpiCept will receive a $3 million fee and an additional $2 million upon the first commercial launch of Ceplene in a major European market, which is expected later this year. Additional payments include a $5 million payment upon achievement of a regulatory milestone and up to $30 million in sales-based milestones that commence upon attainment of at least $50 million in annual sales. EpiCept will receive a double digit percent royalty on net sales in the covered territories and will be responsible for Ceplene’s commercial supply.
“This agreement represents a significant milestone for EpiCept and welcome news for patients suffering from AML in Europe, who will now be able to readily access this life saving medicine once launched,” remarked Jack Talley, president and CEO of EpiCept. “Meda's strengths and assets are exactly those that we sought from the start of our selection process, including vast marketing and distribution coverage throughout Europe and a deep knowledge of and relationships within the oncology space. From a corporate perspective, we believe this agreement provides us with the resources needed to continue our growth as a commercial enterprise with a host of near-term and long-term value drivers. It also will allow us to more fully focus on preparing our new drug application to the U.S. Food and Drug Administration for Ceplene later this year, and on expanding its use in other hematologic malignancies. We look forward to working closely with Meda in the commercialization of Ceplene.”
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. 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).
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, 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 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 our 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 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 EpiCept™ 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™ 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.