EDT receives European approval for XEPLION injection to treat schizophrenia

Mar 9 2011

Elan Drug Technologies (EDT), the drug delivery unit of Elan Corporation, plc (NYSE: ELN), today announced that the first injectable product using EDT's NanoCrystal^® technology has been approved by the European Commission. XEPLION^®, Janssen-Cilag International NV's long-acting injectable treatment for patients with schizophrenia which uses EDT's NanoCrystal^® technology, was approved by the European Commission earlier today.

"The European approval of XEPLION^® is an important milestone for our NanoCrystal^® technology as it marks the first long-acting injectable product approved by the European regulatory authorities using this technology," said Shane Cooke, Executive Vice President and Chief Financial Officer of Elan and Head of EDT. "The versatility of our NanoCrystal^® technology enabled the development of a long-acting injectable antipsychotic which is designed to help patients maintain continual treatment, reduce the likelihood of relapse and thereby potentially improve their overall quality of life."

On March 9, 2011, Janssen-Cilag International NV, one of the Janssen Pharmaceutical Companies, announced the approval of XEPLION^®, a once monthly atypical antipsychotic injection, by the European Commission. XEPLION^® is indicated for maintenance treatment of schizophrenia in adult patients stabilised with paliperidone or risperidone. In selected adult patients with schizophrenia and previous responsiveness to oral paliperidone or risperidone, XEPLION^® may be used without prior stabilisation with oral treatment if psychotic symptoms are mild to moderate and a long-acting injectable treatment is needed.

EDT's NanoCrystal^® technology enables the formulation of poorly water soluble compounds for all routes of administration. The technology allows for a ready-to-use, one-month duration, intramuscular injection 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, thereby negating the need for a power injector. By applying the NanoCrystal^® technology to paliperidone palmitate, healthcare professionals will be able to provide patients with consistent medication coverage for one month, potentially allowing them to improve compliance for patients with schizophrenia.

NanoCrystal^® technology is a proprietary technology developed by EDT through Elan Pharma International Limited and other Elan affiliates. XEPLION^® is the fourth licensed product using Elan's NanoCrystal^® technology that has been approved by the EMA.