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SOUTH SAN FRANCISCO, CA -- (MARKET WIRE) -- 04/19/07 -- Novacea, Inc. (NASDAQ: NOVC) today
announced that the company has reached an agreement with KuDOS
Pharmaceuticals Ltd (KuDOS), a wholly owned subsidiary of AstraZeneca UK
Ltd (AstraZeneca), and BTG plc (BTG) regarding its investigational
anti-cancer agent AQ4N (banoxantrone). As part of the agreement, Novacea
will acquire an exclusive license in respect of the rights for the
worldwide development and commercialization of AQ4N. KuDOS anticipates it
will complete patient recruitment for its ongoing Phase I clinical trials
with AQ4N around the middle of 2007.
Prior to its acquisition by AstraZeneca in 2006, KuDOS acquired a worldwide
license for AQ4N from BTG in March 2002 and subsequently licensed the North
American rights for AQ4N to Novacea in December 2003. AQ4N was originally
discovered by Professor Laurence Patterson, Ph.D., currently director of
the Institute of Cancer Research at the University of Bradford in England,
working in collaboration with BTG.
"We are pleased to have reached agreement with AstraZeneca and BTG on
acquiring the worldwide rights for AQ4N. The extensive pre-clinical and
clinical data generated to date gives us confidence in the significant
opportunity AQ4N presents as an anti-cancer agent in multiple tumor types
and hematological malignancies," said John P. Walker, chairman and interim
chief executive officer of Novacea. "As reported this week at the American
Association for Cancer Research, investigators presented new and important
pre-clinical evidence that AQ4N in combination with mitoxantrone is able to
permeate deeply within all tumor types and selectively accumulates in
hypoxic tumor cells. This agreement will allow us to manage all strategic
development and resource decisions in support of AQ4N."
About AQ4N
AQ4N is a novel, tumor-selective prodrug with potential applicability to
multiple tumor types, both in combination with a number of chemotherapeutic
agents and as a monotherapy for hematological malignancies. AQ4N is an
inert, oxidized derivative of AQ4, a well-characterized Topoisomerase II
inhibitor, which exhibits potent cytotoxicity comparable to other marketed
Topoisomerase II inhibitors such as Novantrone® (mitoxantrone) and
Adriamycin® (doxorubicin). In November 2006, Novacea initiated a
multi-center Phase 1b/2a open-label clinical study of AQ4N in combination
with radiotherapy and temozolomide in patients who were newly diagnosed
with glioblastoma multiforme (GBM).
About Novacea
Novacea, Inc. is a biopharmaceutical company focused on in-licensing,
developing and commercializing novel cancer therapies. Novacea has two
product candidates in clinical trials, including Asentar(TM), which
currently is in a Phase 3 clinical trial for androgen-independent prostate
cancer, or AIPC. Novacea's second product candidate, AQ4N, is a
hypoxia-activated prodrug that is currently in a Phase 1b/2a clinical trial
in glioblastoma multiforme. More information on any of Novacea's trials
can be found at www.ClinicalTrials.gov.
Note: Except for the historical information contained herein, the matters
set forth in this press release, including statements as to financial
guidance, development, clinical studies, regulatory review and approval,
and commercialization of products, are forward-looking statements within
the meaning of the "safe harbor" provisions of the Private Securities
Litigation Reform Act of 1995. Forward-looking statements speak only as of
the date the statements are made and are based on information available at
the time those statements are made and/or management's good faith belief as
of that time with respect to future events. You should not put undue
reliance on any forward-looking statements. Important factors that could
cause actual performance and results to differ materially from the
forward-looking statements we make include: early stage of development; the
focus, conduct, enrollment and timing of our clinical trials; regulatory
review and approval of product candidates; commercialization of products;
developments relating to our licensing and collaboration agreements; market
acceptance of products; funding requirements; intellectual property
protection for our product candidates; competing products and other risks
detailed from time to time under the heading "Risk Factors" in our most
recent Quarterly Report on Form 10-Q or Annual Report on Form 10-K, as may
be updated from time to time by our future filings under the Securities
Exchange Act. If one or more of these risks or uncertainties materialize,
or if any underlying assumptions prove incorrect, our actual performance or
results may vary materially from any future performance or results
expressed or implied by these forward-looking statements. We assume no
obligation to update forward-looking statements to reflect actual
performance or results, changes in assumptions or changes in other factors
affecting forward-looking information, except to the extent required by
applicable securities laws.
Novacea is a registered trademark of Novacea, Inc., and Asentar is
a trademark of Novacea, Inc. All other trademarks are property of their
respective owners.