Ceplene(R) Receives Positive European Opinion for Approval From CHMP


Ceplene(R) Receives Positive European Opinion for Approval From CHMP

Marketing Authorization Normally Anticipated within 67 Days in the EU

Conference Call to be Held July 28 at 9:00 a.m. Eastern Time

Regulatory News:

    EpiCept Corporation (Nasdaq and OMX Nordic Exchange: EPCT)
announced today that the Committee for Medicinal Products for Human
Use (CHMP) of the European Medicines Agency (EMEA) has issued a
positive opinion regarding the marketing authorization for Ceplene(R)
(histamine dihydrochloride), for the remission maintenance and
prevention of relapse in adult patients with Acute Myeloid Leukemia
(AML) in first remission. Ceplene is to be administered in conjunction
with low-dose interleukin-2 (IL-2). This positive opinion was issued
following a request made by EpiCept to have the initial negative
opinion of March 2008 re-examined by the CHMP. Ceplene has been
designated as an orphan medicinal product, and as such is entitled to
10 years of marketing exclusivity in the EU.

    EpiCept attended an oral explanation hearing at the CHMP's plenary
meeting on July 22, 2008. Following this oral explanation, the CHMP
recommended that Ceplene be granted a full marketing authorization
under the provision of Exceptional Circumstances.

    As part of granting of the marketing authorization under
Exceptional Circumstances, EpiCept has agreed to perform two
post-approval clinical studies. One of the studies seeks to further
elucidate the clinical pharmacology of Ceplene by assessing certain
biomarkers in AML patients in first remission. The other study will
assess the effect of Ceplene/IL-2 on the development of minimal
residual disease in the same patient population. EpiCept is entitled
to seek further guidance on the design of such studies from the EMEA
through the protocol assistance procedure."We are thrilled with the positive opinion reached by the CHMP and
are pleased by the overwhelming support for Ceplene we received from
key opinion leaders in hematology across Europe during this successful
re-examination effort," stated Jack Talley, President and CEO of
EpiCept. "Ceplene, in conjunction with IL-2, is the first therapy
shown to significantly prolong leukemia-free survival and prevent
relapse in AML patients in first remission."

    The CHMP's recommendation will now be forwarded to the European
Commission for issuing a marketing authorization in the form of a
Commission Decision, which normally occurs within 67 days. The
marketing authorization with unified clinical usage for Ceplene
granted under the Centralized Procedure will be valid for the entire
European Union as well as in Iceland, Liechtenstein and Norway."We are highly optimistic about the commercial prospects for
Ceplene and we intend to pursue its commercial introduction as
expeditiously as possible," continued Mr. Talley. "We are evaluating
all of our strategic options for the marketing of Ceplene, and will
continue to work towards realizing the drug's potential to fulfill an
important unmet medical need for AML patients in Europe."

    Conference Call

    EpiCept announced that it will host a conference call to discuss
this opinion and the Ceplene program on Monday, July 28, 2008 at 9:00
a.m. Eastern Daylight Time.

    To listen to the conference call, please dial:

    (877) 494-5472 (United States and Canada)
(706) 758-9407 (International)
The access code for the call is 57724791

    A web cast of the conference can be accessed at www.epicept.com.
The webcast will be archived for 90 days.

    A playback of the call will be available for one week and may be
accessed by dialing:

    (800) 642-1687 (United States and Canada)
(706) 645-9291 (International)
Please reference reservation number 57724791

    About Acute Myeloid Leukemia (AML)

    AML is the most common type of leukemia in adults. There are
approximately 40,000 AML patients in the EU, with 16,000 new cases
occurring each year. Once diagnosed with AML, patients are typically
treated with induction chemotherapy and consolidation therapy, with
the majority achieving complete remission. However, about 75-80% of
patients who achieve first remission will relapse, with the median
time in remission before relapse being only 12 months with current
treatments. Less than 5% of relapsed patients survive long term.

    About Ceplene

    Ceplene is EpiCept's compound for the treatment of AML. 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.

    About EpiCept Corporation

    EpiCept is focused on unmet needs in the treatment of cancer and
pain. The Company's broad portfolio of pharmaceutical product
candidates includes several pain therapies in clinical development and
a lead oncology compound for AML. In addition, EpiCept's ASAP
technology, a proprietary live cell high-throughput caspase-3
screening technology, can efficiently identify new cancer drug
candidates and molecular targets that selectively induce apoptosis in
cancer cells. Two oncology drug candidates currently in clinical
development that were discovered using this technology have also been
shown to act as vascular disruption agents in a variety of solid
tumors.

    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 EpiCept's 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 risks that
Ceplene(R) will not receive final regulatory approval or marketing
authorization in the EU, the risk that Ceplene(R), if approved, will
not achieve significant commercial success, the risk that any
post-approval clinical study will not be successful, the risk that
EpiCept will not be able to maintain its final regulatory approval or
marketing authorization if received, the risks associated with the
adequacy of our existing cash resources and our need to raise
additional financing to continue to meet our capital needs 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 or that we may default on our loans or that our lenders may
declare the Company in default or that our secured lender would seek
to sell our assets, the risk that the Company's 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 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 our ASAP technology
will not yield any successful product candidates, the risk that
clinical trials for NP-1 or EPC2407 will not be successful, the risk
that NP-1 or EPC2407 will not receive regulatory approval or achieve
significant commercial success, 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; risks associated with prior material
weaknesses in our internal controls; and risks associated with our
ability to protect our intellectual property. These factors and other
material risks are more fully discussed in EpiCept's periodic reports,
including its 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 EpiCept's
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.

EpiCept Corporation:
             Robert W. Cook, 914-606-3500
             rcook@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

Attachments

07252118.pdf