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® 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® NCD.
the License Agreement and corresponding Services
Agreement, Elan will manufacture EntreMed's Panzem® 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® (marketed by Abbott),
Megace® ES (marketed by Par Pharmaceuticals),
and Rapamune® (marketed by Wyeth). In 2004, the
parties signed a Clinical Supply Agreement covering
the supply of Panzem® NCD for Phase 1 trials.
These Agreements extend the Panzem® NCD supply
arrangement to Phase 2 and later trials. Panzem® 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
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."
President and Chief Executive Officer, James S.
Burns commented, "These agreements continue
our relationship with Elan for further development
and manufacturing of Panzem® 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."
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® NCD towards commercialization."
Elan's NanoCrystal® 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
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.
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® Nanocrystal Colloidal
Dispersion (Panzem® 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.
Inc. (Nasdaq: ENMD) is a clinical-stage pharmaceutical
company developing therapeutic candidates primarily
for the treatment of cancer and inflammation. Panzem® (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 Exchange
is a registered trademark owned by Elan Pharma
International Limited Corporation, Ireland.
a registered trademark owned by EntreMed, Inc.
a registered trademark owned by Abbott Laboratories
a registered trademark of Bristol-Myers Squibb
Company licensed to Par Pharmaceutical, Inc.
a registered trademark owned by Wyeth Pharmaceuticals.
Forward Looking Statements
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).
Contacts: 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.
CONTACT: 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,
Web site: http://www.entremed.com