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Elan Drug Technologies announces first approval of a long acting injectable
formulation using NanoCrystal® Technology
Fifth product approved by the US FDA licensing Elan’s NanoCrystal® technology
for various formulations
DUBLIN, IRELAND, August 3rd 2009, Elan Drug Technologies, a business unit of
Elan Corporation, plc (NYSE: ELN) announces the first approval of a long acting
injectable formulation using Elan Drug Technologies’ proprietary NanoCrystal®
technology.
Late last week, Janssen, a division of Ortho-McNeil-Janssen Pharmaceuticals,
announced the approval of INVEGA® SUSTENNA™, the first once monthly atypical
antipsychotic injection, by the United States Food and Drug Administration.
“The approval of INVEGA® SUSTENNA™, is an important milestone for our
NanoCrystal® technology as it marks the first long acting injectable product
approved by regulatory authorities using the technology” announced Shane Cooke,
Executive Vice President and Head of Elan Drug Technologies. “Our versatile
NanoCrystal® technology in this instance, allowed for a stable, low viscosity,
high drug loaded formulation in a small injection volume, to be developed”.
The NanoCrystal® technology, a technology enabling the formulation of poorly
water soluble compounds for all routes of administration, allows for a
ready-to-use one month duration intramuscular depot formulation of paliperidone
palmitate which can be administered by healthcare professionals. The
intramuscular injection is administered using a small bore needle and small
volume syringe, negating the need for a power injector. By applying the
NanoCrystal® technology to paliperidone palmitate, for the first time,
healthcare professionals will be able to provide patients with consistent
medication coverage for one month potentially allowing them to improve
compliance for schizophrenic patients.
NanoCrystal® technology, is a proprietary technology developed by Elan Drug
Technologies through Elan Pharma International Limited and other Elan
affiliates. INVEGA® SUSTENNA™ is the fifth licensed product approved by the US
FDA using Elan’s NanoCrystal® technology.
About Elan Drug Technologies and NanoCrystal® technology
Elan Drug Technologies (EDT), one of the world’s leading drug delivery
businesses, is a business unit of Elan (NYSE:ELN). As a fully integrated drug
delivery business, Elan Drug Technologies delivers clinically meaningful
benefits to patients, by using its extensive experience and proprietary delivery
technologies in collaboration with pharmaceutical companies. For almost 40
years, Elan Drug Technologies has been, and continues to be, a drug delivery
provider of choice for a broad range of pharmaceutical companies, including many
of the world’s leading pharmaceutical companies. Elan Drug Technologies offer
clients drug delivery expertise with a suite of commercially launched,
proprietary, technology-driven solutions, from NanoCrystal® technology for
poorly water soluble compounds, to customised oral controlled release drug
technologies. Products enabled by their technologies are used by millions of
patients each day. For more information go to
www.elandrugtechnologies.com
Important Safety Information For INVEGA® SUSTENNA™
Visit http://www.INVEGASUSTENNA.com
for full prescribing information.
INVEGA® SUSTENNA™ is a trademark of Johnson & Johnson family of companies.
NanoCrystal® is a registered trademark of Elan Pharma International Limited,
Ireland, a subsidiary of Elan Corporation plc (NYSE:ELN).
Safe Harbour/Forward-Looking Statements
The statements in this press release that are not historical facts are
forward-looking statements that involve risks and uncertainties. A further list
and description of the risks, uncertainties and other matters that confront us
can be found in our Annual Report on Form 20-F for the fiscal year ended
December 31, 2008, and in our Reports of Foreign Issuer on Form 6-K filed with
the U.S. Securities and Exchange Commission. We assume no obligation to update
any forward-looking statements, whether as a result of new information, future
events or otherwise.
Source: Elan Corporation, plc
Elan Corporation, plc
Investors:
Chris Burns, 800-252-3526
Chris.Burns@elan.com
or
David Marshall, 353-1-709-4444
David.Marshall@elan.com
or
Media:
Miriam Mason, 650-278-7113 (onsite)
Miriam.Mason@elan.com
or
Mary Stutts, 650-794-4403
Mary.Stutts@elan.com
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