Healthcare Industry News: KuDOS Pharmaceuticals
News Release - April 19, 2007
Novacea Acquires Worldwide Development and Commercialization Rights for Its Oncology Candidate AQ4NSOUTH SAN FRANCISCO, CA--(Healthcare Sales & Marketing Network)--Apr 19, 2007 -- Novacea, Inc. (NasdaqGM: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."
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).
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.
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