InvegaTreatment for Schizophrenia, Schizoaffective Disorder
Elan Announces the Johnson & Johnson Pharmaceutical Research & Development Submission of a New Drug Application to the FDA for Paliperidone Palmitate Using Elan's Proprietary NanoCrystal Technology
DUBLIN, Ireland--(BUSINESS WIRE)--Oct 29, 2007 - Elan Corporation, plc today announced that Johnson & Johnson Pharmaceutical Research & Development, L.L.C (J&JPRD) has submitted a New Drug Application to the U.S. Food and Drug Administration (FDA) for paliperidone palmitate, an investigational, once-monthly atypical antipsychotic intramuscular injection for the treatment of schizophrenia and the prevention of recurrence of the symptoms of schizophrenia. Paliperidone palmitate is a long acting injectable ester of the active ingredient in Invega(1) and utilizes Elan's NanoCrystal(R) Technology.
Under the terms of Elan's License Agreement, Elan is eligible to receive payments upon the achievement of certain milestones. Additionally, Elan will receive royalty payments based on sales of the injectable paliperidone palmitate formulation, if the product is successfully commercialized.
"We are very pleased to see this product application being filed with the US regulatory authorities. If the product is approved for marketing by the regulators, we look forward to the successful launch of this product in the U.S. and other territories. This is the first long acting injectable product developed and submitted to a Health Authority using Elan's NanoCrystal(R) Technology and marks a significant milestone in the advancement of the technology," commented Shane Cooke, Chief Financial Officer and Head of Elan Drug Technologies.
About NanoCrystal Technology and Elan Drug Technologies
The use of Elan's NanoCrystal(R) Technology increases the rate of dissolution of the poorly water soluble paliperidone palmitate compound and enables the formulation of an aqueous suspension for once-monthly administration. The technology, which can offer enhanced commercialization opportunities, is covered by numerous U.S. and foreign patents and is part of a suite of technologies which Elan's Drug Technologies business offers to third party clients. The drug in nano-form can be incorporated into common dosage forms, including tablets, capsules, inhalation devices, and sterile forms for injection, with the potential for substantial improvements to clinical performance.
Currently four products marketed in the United States/Internationally utilize Elan's NanoCrystal(R) Technology: TriCor(R)/ Lipanthyl(R) (marketed by Abbott, Solvay), Megace(R) ES (marketed by Strativa Pharmaceuticals, a division of Par Pharmaceutical), Rapamune(R) (marketed by Wyeth) and Emend(R) (marketed by Merck).
The NanoCrystal Technology is part of a suite of capabilities available through Elan Drug Technologies (EDT). With over 30 products launched in 40 countries, EDT has a proven track record of collaborating with pharmaceutical companies. For more information about Elan Drug Technologies please visit www.elan.com/EDT.
(1) Invega is a once-daily oral atypical antipsychotic for the treatment and maintenance of schizophrenia. Invega was discovered and developed by Johnson & Johnson Pharmaceutical Research & Development, L.L.C (J&JPRD), and is marketed in the U.S. by Janssen, L.P.
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.
NanoCrystal(R) Technology is a registered trademark owned by Elan Pharma International Limited, Ireland.
TriCor(R) is a registered trademark owned by Abbott Laboratories Corporation.
Lipanthyl(R) is a registered trademark owned by Solvay SA.
Megace(R) is a registered trademark owned by Bristol-Myers Squibb Company licensed to Par Pharmaceutical, Inc.
Rapamune(R) is a registered trademark owned by Wyeth Pharmaceuticals.
Emend(R) is a registered trademark owned by Merck & Co., Inc.
Forward-Looking Statements This press release contains forward-looking statements that involve substantial risks and uncertainties, including whether the License Agreement will be terminated, whether Elan will earn any further milestones under such Agreement, whether the product will be successfully commercialized, and, if so, whether Elan will receive any royalties on sales of the product, and whether Elan's patents will provide any proprietary protection for the Elan technologies
A list and description of additional risks, uncertainties and other matters can be found in Elan's Annual Report on Form 20-F for the fiscal year ended December 31, 2006 and in its Reports of Foreign Issuer on Form 6-K filed with the Securities and Exchange Commission . Elan assumes no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.
Elan Corporation, plc
Jonathan Birt, 212 850 5664
Elizabeth Headon, 353 1 498 0300
Chris Burns, 353 1 709 4444
800 252 3526
Posted: October 2007
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- Invega Approved as the First and Only Treatment for Schizoaffective Disorder - August 6, 2009
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Announces FDA Filings for Paliperidone Palmitate and Invega - February 6, 2009
- FDA Issues Complete Response Letter for Paliperidone Palmitate for the Treatment of Schizophrenia - August 27, 2008
- FDA Approves Invega for Long-Term Maintenance Treatment ofSchizophrenia - April 27, 2007
- Invega Approved By FDA as New Treatment for Schizophrenia - December 21, 2006
- Janssen, L.P. Selects Invega (paliperidone) Extended Release Tablets as Brand Name for Its Investigational Atypical Antipsychotic - November 10, 2006
- FDA Issues Approvable Letter for Paliperidone ER for the Treatment of Schizophrenia - September 29, 2006
- New Drug Application Submitted for Paliperidone - a Potential New Treatment for Schizophrenia - November 30, 2005