10.01.2006 07:30:00
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Elan and EntreMed Execute License Agreement for Proprietary NanoCrystal(R) Technology
Under the License Agreement and corresponding Services Agreement,Elan will manufacture EntreMed's Panzem(R) NCD, a NanoCrystalTechnology formulation with improved bioavailability and absorption.Other marketed pharmaceutical products in the United States utilizingElan's NanoCrystal Technology include TriCor(R) (marketed by Abbott),Megace(R) ES (marketed by Par Pharmaceuticals), and Rapamune(R)(marketed by Wyeth). In 2004, the parties signed a Clinical SupplyAgreement covering the supply of Panzem(R) NCD for Phase 1 trials.These Agreements extend the Panzem(R) NCD supply arrangement to Phase2 and later trials. Panzem(R) NCD is currently in Phase 1b clinicalstudies in patients with advanced cancer. EntreMed expects to announcethe commencement of multiple Phase 2 trials in early 2006.
Paul V. Breen, Executive Vice President, Elan Drug Technologies,said, "We are pleased to extend our relationship with EntreMed. Wehope that these agreements will lead to the launch of a new productwith unique benefits to cancer patients."
EntreMed President and Chief Executive Officer, James S. Burnscommented, "These agreements continue our relationship with Elan forfurther development and manufacturing of Panzem(R) NCD, our leadclinical drug candidate. Interim results from our Phase 1b studiesdemonstrated that daily dosing with the Elan formulation maintainsblood levels of 2ME2 within the desired therapeutic range, allowing usto move forward with Phase 2 clinical trials."
Mr. Burns further commented, "Expanding the Elan relationship is alogical next step for EntreMed that provides us with access to processimprovements and continuity of supply for further scale-up andclinical development. We look forward to working closely with Elan tomeet our development goals and move Panzem(R) NCD towardscommercialization."
About Elan's NanoCrystal(R) Technology
Elan's NanoCrystal Technology is a novel drug delivery technologythat offers superior results when coupled with poorly water-solublecompounds. An increasing number of the drug candidates synthesizedeach year by pharmaceutical companies are poorly water-soluble. Manyof these potentially innovative drug candidates are often abandonedbecause of poor pharmacokinetic properties including absorption,distribution, metabolism, and excretion. NanoCrystal Technology hasthe potential to rescue a significant percentage of these chemicalcompounds.
Elan's NanoCrystal Technology is part of a suite of technologieswhich Elan's Drug Technologies business offers to third party clients.Elan Drug Technologies offers its' technology based solutions to theglobal pharmaceutical industry. With over 30 products launched in 40countries, it has a proven track record of delivering success to thirdparty clients. More information about Elan Drug Technologies broadrange of technologies, patent estate and range of services isavailable at www.elan.com/EDT.
About Elan
Elan is a neuroscience-based biotechnology company that is focusedon discovering, developing, manufacturing, selling and marketingadvanced therapies in neurodegenerative diseases, autoimmune diseasesand severe pain. Elan's (NYSE:ELN) shares trade on the New York,London and Dublin Stock Exchanges.
About Panzem(R) NCD
2ME2 is an orally active small molecule that attacks tumor cellsthrough multiple mechanisms of action and blocks the development ofnew blood vessels that feed tumor cells. Panzem(R) NanocrystalColloidal Dispersion (Panzem(R) NCD), an oral liquid formulation, hasbeen shown in pre-clinical studies to significantly increase thedrug's bioavailability, which is expected to result in enhanced druglevels of 2ME2 in patients.
About EntreMed
EntreMed, Inc. (NASDAQ: ENMD) is a clinical-stage pharmaceuticalcompany developing therapeutic candidates primarily for the treatmentof cancer and inflammation. Panzem(R) (2-methoxyestradiol or 2ME2),the Company's lead drug candidate, is currently in clinical trials forcancer, as well as in preclinical development for non-oncologyindications. EntreMed recently announced that it will acquire MiikanaTherapeutics, Inc., a clinical-stage oncology company headquartered inFremont, California. EntreMed's goal is to develop and commercializenew compounds based on the Company's expertise in angiogenesis, cellcycle regulation and inflammation -- processes vital to the treatmentof cancer and other diseases, such as rheumatoid arthritis. Additionalinformation about EntreMed is available on the Company's website atwww.entremed.com and in various filings with the Securities andExchange Commission.
NanoCrystal(R) Technology is a registered trademark owned by ElanPharma International Limited Corporation, Ireland.
Panzem(R) is a registered trademark owned by EntreMed, Inc.
TriCor(R) is a registered trademark owned by Abbott LaboratoriesCorporation.
Megace(R) is a registered trademark of Bristol-Myers SquibbCompany licensed to Par Pharmaceutical, Inc.
Rapamune(R) is a registered trademark owned by WyethPharmaceuticals.
Forward Looking Statements
This release contains forward-looking statements within themeaning of the Private Securities Litigation Reform Act with respectto the outlook for expectations for future financial or businessperformance, strategies, expectations and goals. Forward-lookingstatements are subject to numerous assumptions, risks anduncertainties, which change over time. Forward-looking statementsspeak only as of the date they are made, and no duty to updateforward-looking statements is assumed. Actual results could differmaterially from those currently anticipated due to a number offactors, including those set forth in Securities and ExchangeCommission filings under "Risk Factors," including risks relating tothe need for additional capital and the uncertainty of additionalfunding; the early-stage products under development; results inpreclinical models are not necessarily indicative of clinical results,uncertainties relating to preclinical and clinical trials; success inthe clinical development of any products; dependence on third parties;future capital needs; and risks relating to the commercialization, ifany, of the Company's proposed products (such as marketing, safety,regulatory, patent, product liability, supply, competition and otherrisks).
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