DUBLIN, Ireland and ROCKVILLE, Md., Jan. 10 /PRNewswire-FirstCall/ -- 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
(Logo: http://www.newscom.com/cgi-bin/prnh/20010620/ENMDLOGO )
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
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 http://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
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
http://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 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).
Elan Corporation EntreMed, Inc.
Investors: Media: Communications/IR:
Emer Reynolds Davia Temin Ginny Dunn
+353-1-709-4000 212-407-5740 240-864-2643
800-252-3526 Elizabeth Headon
Chris Burns +353-1-498-0300
SOURCE Elan Corporation, plc; EntreMed, Inc.
Investors: Emer Reynolds, +353-1-709-4000, +1-800-252-3526, Chris Burns, +1-800-252-3526; Media: Davia Temin, +1-212-407-5740, Elizabeth Headon, +353-1-498-0300, all of Elan Corporation; or Ginny Dunn of EntreMed, Inc., +1-240-864-2643
-0- Jan/10/2006 7:30 GMT
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