EpiCept Announces Ceplene® Included in Swedish AML Medical Guidelines

EpiCept Announces Ceplene® Included in Swedish AML Medical Guidelines 

First Official Endorsement by Medical Community 

TARRYTOWN, N.Y.--(BUSINESS WIRE)-- Regulatory News: 

EpiCept Corporation (Nasdaq and OMX Stockholm Exchange: EPCT) announced today
that the Swedish AML Group which comprises the leading hematology experts in
Sweden has included Ceplene® (histamine dihydrochloride) in its Guidelines
entitled “National Guidelines for Diagnosis and Treatment of Acute Myeloid
Leukemia in Adults.” These guidelines, which were issued earlier this month,
recommend for the first time the inclusion of Ceplene for AML remission
maintenance therapy. Ceplene plus low-dose interleukin (IL-2) is indicated for
remission maintenance and prevention of relapse in adult patients with Acute
Myeloid Leukemia (AML) in first remission by the European Medicines Evaluation
Agency (EMEA). 

Earlier this month, EpiCept entered into an exclusive commercialization
agreement for Ceplene with Meda AB, (OMX Stockholm Exchange: MEDA-A-ST) a
leading international specialty pharmaceutical company based in Stockholm. Meda
is expected to launch Ceplene this year. 

“The issuance of these medical guidelines is a significant step forward in
recognizing the importance of Ceplene plus IL-2 as a remission maintenance
therapy for patients suffering from AML in Europe, as it raises the awareness
among physicians for this life-saving medicine,” remarked Jack Talley, President
and CEO of EpiCept. “Ceplene will be able to be utilized without restrictions
upon its commercial launch by Meda, while in the meantime it is available
through the Named Patient Program at Idis. The guidelines also make reference to
our ongoing Phase IV study, a post-approval clinical study. This study is
intended to further demonstrate the clinical pharmacology of Ceplene by
assessing certain immunologic biomarkers in AML patients in first remission, and
to measure the effect of Ceplene/IL-2 on minimal residual disease in the same
patient population. Secondary objectives will assess leukemia-free survival
after a follow-up period of up to two years,” Mr. Talley added. EpiCept intends
to work with the European Leukemia Net (ELN) and other national authorities in
Europe along with Meda to incorporate Ceplene into AML practice guidelines
consistent with the approved labeling. 

About 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 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. 

Forward-Looking Statements 

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 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. 

EPCT-GEN 

*Azixa is a registered trademark of Myriad Genetics, Inc.

Contacts
EpiCept Corporation:
Robert W. Cook, 914-606-3500
mail@epicept.com
or
Media:
Feinstein Kean Healthcare
Greg Kelley, 617-577-8110
gregory.kelley@fkhealth.com
or
Investors:
Lippert/Heilshorn & Associates
Kim Sutton Golodetz, 212-838-3777
kgolodetz@lhai.com
or
Bruce Voss, 310-691-7100
bvoss@lhai.com