Elan's NanoCrystal technology approved for long-acting injectable formulation

9 August 2009

Elan Drug Technologies, a business unit of Elan Corporation, plc (NYSE: ELN) has announced the first approval of a long-acting injectable formulation using its proprietary NanoCrystal technology.

Janssen, a division of Ortho-McNeil-Janssen Pharmaceuticals, has announced the approval of Invega Sustenna, the first once monthly atypical antipsychotic injection, by the US FDA.

“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 enables the formulation of poorly water soluble compounds for all routes of administration. It 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.

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