17.07.2008 04:01:00
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EpiCept and GNI Partner to Develop Anti-Viral Hepatitis Drug in Asia
Regulatory News:
GNI Ltd, a leading biopharmaceutical company in Japan and China, and
EpiCept Corporation (Nasdaq and OMX Nordic Exchange: EPCT), a US-based
specialty pharmaceutical company, announced today that they have reached
agreement to develop a new therapeutic drug, EP1013, in Asia, Australia,
and New Zealand, for late-stage viral infection-induced hepatitis.
EpiCept will retain the rights in the rest of the world. GNI’s
wholly owned subsidiary, Shanghai Genomics, will start preparation for
pre-IND and clinical development in China immediately.
In return for granting a license to GNI to develop EP1013, EpiCept
earned an upfront license fee and will be eligible to earn milestone
payments and royalties on commercial sales.
EP1013 is a di-peptide small molecule compound with potent and
irreversible inhibitory effect on caspases, a class of enzymes critical
for cell death and inflammatory response. Initial tests of EP1013 by
EpiCept and Shanghai Genomics have shown promising efficacy in animal
models of liver failure, brain ischemia, and myocardial infarction.
EP1013 was discovered by EpiCept scientists and is covered by patents in
the U.S., China, and other key markets.
Liver disease is a "national”
disease in China with more than 20 million people affected by HBV virus
infection. The late stage of HBV infections is characterized by the
dysfunction of liver cells and eventual cell death. Although liver
transplantation may help some patients, it is costly and requires a long
waiting period. Inhibiting liver cell death may help the liver to
recover function. A novel therapy for liver disease represents a large
market opportunity for GNI in China and Japan. GNI intends to complete
toxicology and PK studies to prepare for an IND filing with the Chinese
SFDA as soon as possible.
Dr. Ying Luo, Chief Executive Officer of GNI and Shanghai Genomics,
said, "Both in-house development and external
co-development are important components of our R&D strategy. EP1013 is
complementary to F351, our first drug candidate in Phase I trial for
liver fibrosis. Developing these two products in Asia will establish us
as a leading player in liver disease therapy.” "We are pleased to establish this
collaboration to accelerate the development of EP1013 for a therapeutic
area which is outside of our core focus areas in oncology and pain
management. Caspase inhibitors may provide a new therapeutic modality
for the treatment of degenerative diseases that involve apoptotic cell
death,” added Jack Talley, President and CEO
of EpiCept.
About GNI
Founded in 2001, GNI is a clinical-stage drug development company with
headquarters in Japan and major operation China. After years of
discovery research, the Company has built a portfolio of drug candidates
in cancer and inflammatory disease areas. In June 2005, GNI acquired
Shanghai Genomics, which operates an integrated drug discovery and
development platform in Shanghai, China. The combined strength of GNI
and Shanghai Genomics has resulted in research collaboration with major
international pharmaceutical companies. The Company is also in the
process of acquiring Hengshan Pharmaceuticals, which has more than
15,900 square meter Chinese SFDA certified GMP manufacture facility near
the central Shanghai and nationwide sales/distribution network in China.
For further information, please visit www.gnipharma.com
and www.shanghaigenomics.com.
About EpiCept
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 with
demonstrated efficacy in a Phase III trial; a marketing authorization
application for this compound recently received a negative opinion and
is being re-examined in Europe. 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 press release and 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
related to GNI's plans to pursue development of product candidates and
the timing thereof. Any statements contained in this press release that
are not statements of historical fact may be deemed to be
forward-looking statements. Words such as "continue," "could," "may,"
and similar expressions are intended to identify these forward-looking
statements. There are a number of important factors that could cause
GNI's results to differ materially from those indicated by these
forward-looking statements, including risks associated with the timing
and success of clinical trials and the commercialization of product
candidates. GNI does not undertake any obligation to update
forward-looking statements.
Some forward-looking 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 risk that EP1013 will
not be developed successfully or that EpiCept will not receive any
future payments under the license agreement with GNI, 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 our appeal of the negative opinion regarding the MAA for Ceplene®
will not be successful and that Ceplene®
will not receive regulatory approval or marketing authorization in the
EU, the risk that Ceplene®,
if approved, will not achieve significant commercial success, the risk
that Myriad's development of AzixaTM will not
be successful, the risk that AzixaTM 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.
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