DUBLIN, Ireland & ROCKVILLE, Md.--(BUSINESS WIRE)--Jan. 10, 2006
Elan Corporation, plc (NYSE: ELN) and EntreMed, Inc.
(NASDAQ: ENMD) today announced that they have entered into a License
Agreement in which EntreMed has been granted rights to utilize Elan's
proprietary NanoCrystal Technology to develop the oncology product
candidate, Panzem(R) NCD (2ME2 or 2-methoxyestradiol). Under the terms
of the License Agreement, Elan is eligible to receive payments upon
the achievement of certain clinical, manufacturing, and regulatory
milestones. Additionally, Elan will receive royalty payments based on
sales of Panzem(R) NCD.
Under the License Agreement and corresponding Services Agreement,
Elan will manufacture EntreMed's Panzem(R) NCD, a NanoCrystal
Technology formulation with improved bioavailability and absorption.
Other marketed pharmaceutical products in the United States utilizing
Elan'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 Supply
Agreement covering the supply of Panzem(R) NCD for Phase 1 trials.
These Agreements extend the Panzem(R) NCD supply arrangement to Phase
2 and later trials. Panzem(R) NCD is currently in Phase 1b clinical
studies in patients with advanced cancer. EntreMed expects to announce
the 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. We
hope that these agreements will lead to the launch of a new product
with unique benefits to cancer patients."
EntreMed President and Chief Executive Officer, James S. Burns
commented, "These agreements continue our relationship with Elan for
further development and manufacturing of Panzem(R) NCD, our lead
clinical drug candidate. Interim results from our Phase 1b studies
demonstrated that daily dosing with the Elan formulation maintains
blood levels of 2ME2 within the desired therapeutic range, allowing us
to move forward with Phase 2 clinical trials."
Mr. Burns further commented, "Expanding the Elan relationship is a
logical next step for EntreMed that provides us with access to process
improvements and continuity of supply for further scale-up and
clinical development. We look forward to working closely with Elan to
meet our development goals and move Panzem(R) NCD towards
About Elan's NanoCrystal(R) Technology
Elan's NanoCrystal Technology is a novel drug delivery technology
that offers superior results when coupled with poorly water-soluble
compounds. An increasing number of the drug candidates synthesized
each year by pharmaceutical companies are poorly water-soluble. Many
of these potentially innovative drug candidates are often abandoned
because of poor pharmacokinetic properties including absorption,
distribution, metabolism, and excretion. NanoCrystal Technology has
the potential to rescue a significant percentage of these chemical
Elan's NanoCrystal Technology is part of a suite of technologies
which Elan's Drug Technologies business offers to third party clients.
Elan Drug Technologies offers its' technology based solutions to the
global pharmaceutical industry. With over 30 products launched in 40
countries, it has a proven track record of delivering success to third
party clients. More information about Elan Drug Technologies broad
range of technologies, patent estate and range of services is
available at www.elan.com/EDT.
Elan is a neuroscience-based biotechnology company that is focused
on discovering, developing, manufacturing, selling and marketing
advanced therapies in neurodegenerative diseases, autoimmune diseases
and 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 cells
through multiple mechanisms of action and blocks the development of
new blood vessels that feed tumor cells. Panzem(R) Nanocrystal
Colloidal Dispersion (Panzem(R) NCD), an oral liquid formulation, has
been shown in pre-clinical studies to significantly increase the
drug's bioavailability, which is expected to result in enhanced drug
levels of 2ME2 in patients.
EntreMed, Inc. (NASDAQ: ENMD) is a clinical-stage pharmaceutical
company developing therapeutic candidates primarily for the treatment
of cancer and inflammation. Panzem(R) (2-methoxyestradiol or 2ME2),
the Company's lead drug candidate, is currently in clinical trials for
cancer, as well as in preclinical development for non-oncology
indications. EntreMed recently announced that it will acquire Miikana
Therapeutics, Inc., a clinical-stage oncology company headquartered in
Fremont, California. EntreMed's goal is to develop and commercialize
new compounds based on the Company's expertise in angiogenesis, cell
cycle regulation and inflammation -- processes vital to the treatment
of cancer and other diseases, such as rheumatoid arthritis. Additional
information about EntreMed is available on the Company's website at
www.entremed.com and in various filings with the Securities and
NanoCrystal(R) Technology is a registered trademark owned by Elan
Pharma International Limited Corporation, Ireland.
Panzem(R) is a registered trademark owned by EntreMed, Inc.
TriCor(R) is a registered trademark owned by Abbott Laboratories
Megace(R) is a registered trademark of Bristol-Myers Squibb
Company licensed to Par Pharmaceutical, Inc.
Rapamune(R) is a registered trademark owned by Wyeth
Forward Looking Statements
This release contains forward-looking statements within the
meaning of the Private Securities Litigation Reform Act with respect
to the outlook for expectations for future financial or business
performance, strategies, expectations and goals. Forward-looking
statements are subject to numerous assumptions, risks and
uncertainties, which change over time. Forward-looking statements
speak only as of the date they are made, and no duty to update
forward-looking statements is assumed. Actual results could differ
materially from those currently anticipated due to a number of
factors, including those set forth in Securities and Exchange
Commission filings under "Risk Factors," including risks relating to
the need for additional capital and the uncertainty of additional
funding; the early-stage products under development; results in
preclinical models are not necessarily indicative of clinical results,
uncertainties relating to preclinical and clinical trials; success in
the clinical development of any products; dependence on third parties;
future capital needs; and risks relating to the commercialization, if
any, of the Company's proposed products (such as marketing, safety,
regulatory, patent, product liability, supply, competition and other
Emer Reynolds, +353-1-709-4000
Chris Burns, 800-252-3526
Davia Temin, 212-407-5740
Elizabeth Headon, +353-1-498-0300
Ginny Dunn, 240-864-2643
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