“Our ongoing market planning and product development activities during
the fourth quarter of 2009 and recent weeks were substantial, and we are
very pleased with the progress we made in advancing the development and
commercialization of a number of our products”
EpiCept Corporation (Nasdaq and Nasdaq OMX Stockholm Exchange: EPCT)
today announced operating and financial results for the fourth quarter
and year ended December 31, 2009, and provided an update on Ceplene® and
several of the Company’s key product candidates.
“Our ongoing market planning and product development activities during
the fourth quarter of 2009 and recent weeks were substantial, and we are
very pleased with the progress we made in advancing the development and
commercialization of a number of our products,” noted Jack Talley,
EpiCept’s President and CEO. “Last month we announced the successful
culmination of our partnership negotiations for Ceplene® with the
signing of an agreement with Meda AB to market and sell Ceplene® in
Europe and several Pacific Rim countries. We also made progress with the
New Drug Submission (NDS) for Ceplene® in Canada and with the
anticipated New Drug Application (NDA) filing in the U.S. We were also
pleased by the approval of our application to obtain orphan drug status
in the U.S. for NP-1 in post-herpetic neuralgia, as well as by the
progress in our discussions to partner NP-1 for Phase III development
and commercialization.”
Business Update
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Ceplene® - approved in the European Union for the remission
maintenance and prevention of relapse of patients with Acute Myeloid
Leukemia (AML) in first remission; AML is the most deadly form of
leukemia in adults.
On January 7, 2010 EpiCept announced that it had completed an agreement
with Meda AB of Sweden to market and sell Ceplene® in Europe and certain
Pacific Rim countries. EpiCept received $3 million upon signing the
agreement and will receive another $2 million upon commercial launch,
which is expected in 2010. Future payments include a $5 million fee upon
achievement of a regulatory milestone and up to $30 million in sales
milestones. In addition an escalating, double-digit royalty is payable
on net sales of Ceplene® by Meda. EpiCept is responsible for the
manufacture and supply of Ceplene® for sale by Meda. EpiCept and Meda
are cooperating in the preparation for commercial launch in Europe with
a view towards launching the product as quickly as possible. In the
interim, Ceplene® remains available in Europe through the Named-Patient
Program launched in June 2009 through a partnership with IDIS.
EpiCept continued its association with European LeukemiaNet during the
quarter. The first meeting of the Scientific Advisory Board (SAB) the
Company established in collaboration with the foundation took place in
November 2009. The SAB, which is comprised of several key opinion
leaders in AML who collectively practice in all of the major countries
in the European Union, gathered to formulate strategies to increase
physician awareness and understanding of the benefits of Ceplene® in
treating AML patients. In February 2010 EpiCept attended the
foundation’s annual meeting and participated in discussions with the
goal of including Ceplene® in local European guidelines to treat AML
patients in remission. In January 2010 the Swedish AML Group included
Ceplene® in its guidelines entitled “National Guidelines for
Diagnosis and Treatment of Acute Myeloid Leukemia in Adults.”
EpiCept also continued its efforts to expand the uses for Ceplene®
in other hematologic diseases. A study led by Groupe Francophone des
Myélodysplasies will examine the effects of Ceplene® and low-dose IL-2
in combination with Vidaza® (azacitidine) in the treatment of
patients with higher risk myelodsyplastic syndrome (MDS), a bone marrow
disease that can progress to AML. These patients will already have
demonstrated a hematological response to Vidaza®. This trial is expected
to be completed this year and will be followed by a randomized Phase II
study to determine the efficacy, safety and tolerability of the addition
of Ceplene®/IL-2 to Vidaza® compared with Vidaza® alone in patients with
higher risk MDS.
A Phase I/II study that will research the effects of a regimen of
Ceplene® and low-dose IL-2 in combination with Gleevec®
(imatinib mesylate) on the eradication of minimal residual disease in
adult patients with chronic myeloid leukemia is being developed by the
Nordic Chronic Myeloid Leukemia Study Group, which is comprised of
physicians and researchers in Sweden, Denmark, Norway and Finland. The
primary objective of the study will be to assess the safety of the
combination therapy of Ceplene®/IL-2 with Gleevec® given for six months,
and to assess the number of patients achieving and subsequently
maintaining disease-free survival after discontinuation of Gleevec®.
This trial is expected to commence enrollment later this year.
During the fourth quarter EpiCept continued patient enrollment into its
post-approval clinical study with Ceplene®. The Company plans
to enroll up to 150 patients at approximately 30 centers across Europe
with sites in Sweden, Belgium, France, the U.K., Spain, Germany and
Italy. The two primary objectives of the study are 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® and low-dose
interleukin-2 (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.
The Company’s NDS for Ceplene® is currently under review by Health
Canada, which has established a performance target for the completion of
review and a decision by the fourth quarter 2010. The Company is
appealing a denial for data protection in Canada that it received in the
fourth quarter 2009. A decision on the appeal is expected prior to the
decision date of the NDS application.
EpiCept continues its preparation of an NDA that will be filed with the
U.S. Food and Drug Administration (FDA). The Company intends to file the
NDA once it can incorporate certain manufacturing information that will
become available during the second quarter 2010. Ceplene has received
orphan drug status in the U.S. for the remission maintenance of AML.
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EpiCeptTM NP-1 - a prescription topical analgesic cream
designed to provide long-term relief from the pain of peripheral
neuropathies, which affect more than 15 million people in the U.S.
alone. In January 2010 NP-1 received orphan drug designation in the
U.S. for the treatment of post-herpetic neuralgia. The receipt of
orphan drug status provides marketing exclusivity for seven years for
this indication . EpiCept intends to partner this compound prior to
commencement of a Phase III trial in order to share the costs and
development risk, and ultimately to have that partner market the
product globally upon approval. This effort has attracted the interest
of several prospective partners. The Company is seeking to complete a
partnership in 2010.
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Crinobulin (EPC2407) - a vascular disruption agent that has
demonstrated potent anti-tumor activity in both preclinical and early
clinical studies. In May 2009 EpiCept announced the completion of a
Phase Ia study that determined crinobulin’s maximum tolerated dose and
provided evidence of clinical symptomatic activity and radiographic
evidence of efficacy in end-stage cancer patients. The Company is
preparing to initiate this year a Phase Ib trial for the compound in
combination with the standard dose of appropriate chemotherapy in
several solid tumor types.
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Azixa™ - a compound discovered by EpiCept and licensed to Myriad as
part of an exclusive, worldwide development and commercialization
agreement. Myriad is currently conducting Phase II trials for Azixa™.
In November 2009 Myriad announced interim results of its trial of AzixaTM
in melanoma metastases in which 10 of the 22 patients treated achieved
stable disease and two patients achieved confirmed partial responses.
The dosing of the first patient in a Phase III trial for Azixa™
triggers a milestone payment to EpiCept.
Financial and Operating Highlights
EpiCept’s net loss for the fourth quarter of 2009 was $4.4 million, or
$0.10 per share, and for the year was $38.8 million, or $0.97 per share.
As of December 31, 2009, EpiCept had cash and cash equivalents of $5.1
million, and approximately 44.1 million shares outstanding. EpiCept’s
loss per share and shares outstanding reflect a 1:3 reverse split that
was effected in January 2010.
Fourth Quarter 2009 vs. Fourth Quarter 2008
Revenue
The Company recognized revenue of $0.1 million during the fourth quarter
of 2009, unchanged from the fourth quarter of 2008. For both quarters
revenue consisted primarily of the recognition of license fee payments
previously received from Myriad Genetics, Endo Pharmaceuticals and
Durect.
General and Administrative Expense
General and administrative expense in the fourth quarter of 2009
decreased by 11%, or $0.2 million, to $1.9 million compared with $2.1
million in the fourth quarter of 2008. The decrease was primarily
related to lower professional fees and compensation expenses, partially
offset by higher promotion and advertising expenses related to the
upcoming commercial launch of Ceplene®.
Research and Development (R&D) Expense
Research and development expense in the fourth quarter of 2009 decreased
by approximately 21%, or $0.6 million, to $2.4 million compared
with $3.0 million in the fourth quarter of 2008. The decrease was
primarily related to lower facility and compensation expenses related to
the closing of the Company’s research facility in San Diego.
Other Income (Expense)