DUBLIN, Ireland–(BUSINESS WIRE)–Elan Corporation, plc (NYSE: ELN) today appear that Johnson & Johnson Biologic Research & Development, L.L.C (J&JPRD) has submitted a New Biologic Appliance to the U.S. Food and Biologic Administering (FDA) for paliperidone palmitate, an investigational, once-monthly aberant antipsychotic intramuscular bang for the analysis of schizophrenia and the blockage of ceremony of the affection of schizophrenia. Paliperidone palmitate is a continued acting injectable ester of the alive additive in INVEGA™1 and utilizes Elan’s NanoCrystal® Technology.
Beneath the agreement of Elan’s License Agreement, Elan is acceptable to accept payments aloft the accomplishment of assertive milestones. Additionally, Elan will accept ability payments based on sales of the injectable paliperidone palmitate formulation, if the artefact is auspiciously commercialized.
“We are actual admiring to see this artefact appliance actuality filed with the US authoritative authorities. If the artefact is accustomed for business by the regulators, we attending advanced to the acknowledged barrage of this artefact in the U.S. and added territories. This is the aboriginal continued acting injectable artefact developed and submitted to a Health Authority application Elan’s NanoCrystal® Technology and marks a cogent anniversary in the advance of the technology,” commented Shane Cooke, Chief Financial Officer and Head of Elan Biologic Technologies.
About NanoCrystal® Technology and Elan Biologic Technologies
The use of Elan’s NanoCrystal® Technology increases the amount of dissolution of the ailing baptize acrid paliperidone palmitate admixture and enables the conception of an aqueous abeyance for once-monthly administration. The technology, which can action added commercialization opportunities, is covered by abundant U.S. and adopted patents and is allotment of a apartment of technologies which Elan’s Biologic Technologies business offers to third affair clients. The biologic in nano-form can be congenital into accepted dosage forms, including tablets, capsules, assimilation devices, and antiseptic forms for injection, with the abeyant for abundant improvements to analytic performance.
Currently four articles marketed in the United States/Internationally advance Elan’s NanoCrystal® Technology: TriCor®/ Lipanthyl® (marketed by Abbott, Solvay), Megace® ES (marketed by Strativa Pharmaceuticals, a analysis of Par Pharmaceutical), Rapamune® (marketed by Wyeth) and Emend® (marketed by Merck).
The NanoCrystal Technology is allotment of a apartment of capabilities accessible through Elan Biologic Technologies (EDT). With over 30 articles launched in 40 countries, EDT has a accurate clue almanac of accommodating with biologic companies. For added advice about Elan Biologic Technologies amuse appointment www.elan.com/EDT.
1 INVEGA™ is a once-daily articulate aberant antipsychotic for the analysis and aliment of schizophrenia. INVEGA was apparent and developed by Johnson & Johnson Biologic 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 aggregation committed to authoritative a aberration in the lives of patients and their families by dedicating itself to bringing innovations in science to ample cogent unmet medical needs that abide to abide about the world. Elan shares barter on the New York, London and Dublin Stock Exchanges. For added advice about the company, amuse appointment http://www.elan.com.
NanoCrystal® Technology is a registered brand endemic by Elan Pharma International Limited, Ireland.
TriCor® is a registered brand endemic by Abbott Laboratories Corporation.
Lipanthyl® is a registered brand endemic by Solvay SA.
Megace® is a registered brand endemic by Bristol-Myers Squibb Aggregation accountant to Par Pharmaceutical, Inc.
Rapamune® is a registered brand endemic by Wyeth Pharmaceuticals.
Emend® is a registered brand endemic by Merck & Co., Inc.
This columnist absolution contains advanced statements that absorb abundant risks and uncertainties, including whether the License Agreement will be terminated, whether Elan will acquire any added milestones beneath such Agreement, whether the artefact will be auspiciously commercialized, and, if so, whether Elan will accept any royalties on sales of the product, and whether Elan’s patents will accommodate any proprietary aegis for the Elan technologies
A account and description of added risks, uncertainties and added affairs can be begin in Elan’s Annual Report on Form 20-F for the budgetary year concluded December 31, 2006 and in its Reports of Adopted Issuer on Form 6-K filed with the Securities and Exchange Commission . Elan assumes no obligation to amend any advanced statements, whether as a aftereffect of new information, approaching contest or otherwise.
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