The latest news from academia, regulators
research labs and other things of interest
Posted: Mar 18, 2011
Elan Announces First European Commission Approval of Injectable Treatment Using Elan's NanoCrystal Technology
(Nanowerk News) Elan Drug Technologies (EDT), the leading drug delivery unit of Elan Corporation, plc, announced that the first injectable product using EDT's NanoCrystalŽ technology has been approved by the European Commission. XEPLIONŽ, Janssen-Cilag International NV's long-acting injectable treatment for patients with schizophrenia which uses EDT's NanoCrystalŽ technology, was approved by the European Commission on March 9.
"The European approval of XEPLIONŽ is an important milestone for our NanoCrystalŽ technology as it marks the first long-acting injectable product approved by the European regulatory authorities using the technology," said Shane Cooke, Executive Vice President and Chief Financial Officer of Elan and Head of EDT. "The versatility of our NanoCrystalŽ 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 XEPLIONŽ, a once monthly atypical antipsychotic injection, by the European Commission. XEPLIONŽ 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, XEPLIONŽ 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 NanoCrystalŽ 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 NanoCrystalŽ 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.
NanoCrystalŽ technology is a proprietary technology developed by EDT through Elan Pharma International Limited and other Elan affiliates. XEPLIONŽ is the fourth licensed product using Elan's NanoCrystalŽ technology that has been approved by the EMA.
About Elan Drug Technologies and NanoCrystalŽ technology
Elan Drug Technologies (EDT), one of the world's leading drug delivery businesses, is a business unit of Elan. 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 over 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 NanoCrystalŽ technology for poorly water soluble compounds, to customised oral controlled release drug technologies. To date, over 40 products have been developed using EDT's technologies and are used by millions of patients each day. For more information go to www.elandrugtechnologies.com
NanoCrystalŽ is a registered trademark of Elan Pharma International Limited, Ireland, a subsidiary of Elan Corporation plc.
Janssen- Cilag International NV, is one of the Janssen Pharmaceutical Companies which, are dedicated to addressing and solving the most important unmet medical needs of our time, including oncology (e.g. multiple myeloma and prostate cancer), immunology (e.g. psoriasis), neuroscience (e.g. schizophrenia, dementia and pain), infectious disease (e.g. HIV/AIDS, Hepatitis C and tuberculosis), and cardiovascular and metabolic diseases (e.g. diabetes). Driven by our commitment to patients, we develop sustainable, integrated healthcare solutions by working side-by-side with healthcare stakeholders, based on partnerships of trust and transparency. More information can be found at www.janssen-emea.com