Fifth product approved by the US FDA licensing Elan’s NanoCrystal®
technology for various formulations
Elan Drug Technologies announces first approval of a long acting
injectable formulation using NanoCrystal® Technology
Elan Corporation, plc
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 for various formulations.
About Elan Drug Technologies and NanoCrystal®
technology
Elan Drug Technologies, one of the world’s leading drug delivery
businesses, is a business unit of Elan Corporation, plc. 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
About Elan
Elan Corporation, plc is a neuroscience-based biotechnology company
committed to making a difference in the lives of patients and their
families by dedicating itself to bringing innovations in science to fill
significant unmet medical needs that continue to exist around the world.
Elan shares trade on the New York, London and Dublin Stock Exchanges.
For additional information about the company, please visit http://www.elan.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.
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.
