EpiCept Corporation Receives U.S. Phase II Milestone Payment From Adolor Corporation for LidoPAIN(R) SP (sterile lidocaine patch
September 26 2005 - 1:30AM
PR Newswire (US)
ENGLEWOOD CLIFFS, N.J., Sept. 26 /PRNewswire/ -- EpiCept
Corporation announced today that it has received a milestone
payment from Adolor Corporation (NASDAQ:ADLR) in connection with
Adolor's initiation of a U.S. Phase II trial of a sterile lidocaine
patch trademarked by EpiCept as LidoPAIN(R) SP, a product candidate
for the treatment of post-surgical incisional pain. Adolor has
announced top-line results from the Phase II trial are targeted for
the first half of 2006. (Logo:
http://www.newscom.com/cgi-bin/prnh/20020513/NYM112LOGO ) In July
2003, EpiCept licensed North American rights for its LidoPAIN SP
(sterile lidocaine patch) to Adolor. Under the agreement, Adolor is
responsible for conducting clinical trials, managing the approval
process and, upon receipt of marketing approval, commercializing
the product in North America. "If LidoPAIN SP is approved, we
believe that it will be the first sterile prescription analgesic
patch on the market," said Jack Talley, CEO of EpiCept. "LidoPAIN
SP may also reduce the need for systemically-delivered narcotic
analgesics and NSAIDs. The initiation of the Phase II study by
Adolor marks an important milestone in the advancement of our
pipeline in the U.S." EpiCept is currently conducting its own
pivotal scale Phase III trial of LidoPAIN SP in Europe. The
clinical trial is a randomized, double-blind, placebo-controlled
trial in which at least 450 patients who underwent hernia repair
will receive a LidoPAIN SP patch or placebo patch for 48 hours. The
primary endpoint is self-assessed pain intensity at various times
from four to 24 hours. About EpiCept Corporation EpiCept
Corporation is a specialty pharmaceutical company focused on the
development and commercialization of topically delivered
prescription pain management therapeutics. EpiCept has six products
in clinical development for the treatment of various types of pain:
three are ready to enter, or have entered, pivotal Phase IIb or
Phase III clinical trials. On September 6, 2005, EpiCept announced
that it has entered into a definitive merger agreement with Maxim
Pharmaceuticals, Inc. (Nasdaq: MAXM; SSE: MAXM), a
biopharmaceutical company dedicated to developing innovative cancer
therapeutics. The transaction is anticipated to close during the
fourth quarter of 2005 and is contingent upon approval by Maxim
shareholders and other customary conditions. The newly merged
company, which will be called EpiCept Corporation, combines a
product portfolio of pain therapies with the potential of a
late-stage cancer product and biopharmaceutical discovery
capabilities for apoptosis inducers and inhibitors being designed
to address unmet medical needs in the areas of oncology and
degenerative diseases. Upon the closing of the transaction, the
company expects to trade on the Nasdaq National Market system as
well as the OM Stockholm Exchange under the symbol "EPCT." In
connection with the proposed merger, Maxim and EpiCept will file a
registration statement that contains a proxy statement/prospectus
with the Securities and Exchange Commission. SHAREHOLDERS OF MAXIM
AND OTHER INVESTORS ARE URGED TO READ THE PROXY
STATEMENT/PROSPECTUS (INCLUDING ANY AMENDMENTS OR SUPPLEMENTS TO
THE PROXY STATEMENT/PROSPECTUS) REGARDING THE PROPOSED TRANSACTION
WHEN IT BECOMES AVAILABLE BECAUSE IT WILL CONTAIN IMPORTANT
INFORMATION. Maxim's shareholders will be able to obtain a free
copy of the proxy statement/prospectus, as well as other filings
containing information about Maxim and EpiCept, without charge, at
the SEC's Internet site (http://www.sec.gov/). Copies of the proxy
statement/prospectus and the filings with the SEC that will be
incorporated by reference in the proxy statement/prospectus can
also be obtained, without charge by directing a request to Maxim
Pharmaceuticals, 8899 University Center Lane, Suite 400, San Diego,
CA 92122, Attention: Investor Relations, Telephone: 858-453-4040.
Maxim and its directors and executive officers and EpiCept and its
directors and executive officers may be deemed to be participants
in the solicitation of proxies from the shareholders of Maxim in
connection with the proposed transaction. Information regarding the
special interests of these directors and executive officers in the
merger transaction will be included in the proxy
statement/prospectus of Maxim and EpiCept referred to above.
Additional information regarding the directors and executive
officers of Maxim is also included in Maxim's proxy statement for
its 2005 Annual Meeting of Stockholders, which was filed with the
SEC on January 19, 2005. Additional information regarding the
directors and executive officers of EpiCept is also included in
EpiCept's registration statement on Form S-1, which was filed with
the SEC on April 18, 2005. These documents are available free of
charge at the SEC's web site (http://www.sec.gov/) and from
Investor Relations at Maxim at the address described above. This
press release shall not constitute an offer to sell or the
solicitation of an offer to buy any securities, nor shall there be
any sale of securities in any jurisdiction in which such offer,
solicitation or sale would be unlawful prior to registration or
qualification under the securities laws of any such jurisdiction.
No offering of securities shall be made except by means of a
prospectus meeting the requirements of Section 10 of the Securities
Act of 1933, as amended. Details on the transaction are available
at http://www.epicept.com/. Forward-Looking Statements This press
release contains certain forward-looking statements that involve
risks and uncertainties that could cause actual results to be
materially different from historical results or from any future
results expressed or implied by such forward-looking statements.
Such forward-looking statements include statements regarding the
proposed transaction, the efficacy, safety, and intended
utilization of LidoPAIN SP and other product candidates, the
conduct and results of future clinical trials, and plans regarding
regulatory filings, future research and clinical trials and plans
regarding partnering activities. Factors that may cause actual
results to differ materially include the risk that EpiCept and
Maxim may not be able to complete the proposed transaction, the
risk that product candidates, including LidoPAIN SP, that appeared
promising in early research and clinical trials do not demonstrate
safety and/or efficacy in larger-scale or later clinical trials,
the risk that EpiCept will not obtain approval to market its
products, the risks associated with reliance on outside financing
to meet capital requirements and the risks associated with reliance
on collaborative partners, including Adolor, for further clinical
trials, development and commercialization of product candidates.
You are urged to consider statements that include the words "may,"
"will," "would," "could," "should," "believes," "estimates,"
"projects," "potential," "expects," "plans," "anticipates,"
"intends," "continues," "forecast," "designed," "goal," or the
negative of those words or other comparable words to be uncertain
and forward-looking.
http://www.newscom.com/cgi-bin/prnh/20020513/NYM112LOGO
http://photoarchive.ap.org/ DATASOURCE: EpiCept Corporation
CONTACT: Robert W. Cook, Chief Financial Officer, EpiCept
Corporation, +1-201-894-8980, or Lev Janashvili of Feinstein Kean
Healthcare for EpiCept Corporation, +1-617-577-8110 Web site:
http://www.epicept.com/
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