Fifth Product Approved by USFDA Licensing Elan's Nanocrystal Technology for Various Formulations

Published on August 3, 2009 at 9:24 PM

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.

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

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