Agreement for Proprietary
UK Regulatory Announcement
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
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 commercialization."
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 compounds.
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 Exchange Commission.
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 Corporation.
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 Pharmaceuticals.
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 risks).
CONTACT: Elan Corporation
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
Elan Corporation PLC
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