“We are delighted to see the launch of Ampyra™ in the US following its approval earlier this year. Ampyra™ which incorporates one of our drug delivery technologies  is being manufactured at our facility in Athlone, Ireland”, announced Shane Cooke, Executive Vice President and Head of Elan Drug Technologies. “We wish Acorda every success in getting this important product to the many patients in the US that have walking difficulties as a result of their MS”

Using Elan Drug Technologies MXDAS™ technology, Ampyra™ was developed using a hydrophilic matrix, which controlled the rate of release of dalfampridine through a process of diffusion and erosion in the gastrointestinal tract. Using this technology, consistent therapeutic blood levels can be achieved throughout the dosing period and side effects associated with the immediate release formulations of the drug are potentially reduced.  Ampyra™ is the first New Drug Application (NDA) approved and now launched for a product using the MXDAS™ technology.

This is the first medicine indicated to improve walking speed in people with MS. The launch of Ampyra™ therefore may represent an important new addition to MS therapy. Approximately 400,000-500,000 people in the United States have MS, and recent studies indicate that between 64-85% of people with MS have walking disability. Some 70% of people with MS who have walking disability report it to be the most challenging aspect of their disease.

Ampyra™ will be manufactured by Elan at their Athlone, Ireland facility, based on an existing supply agreement with Acorda.

 
About Ampyra™

Ampyra™ is a potassium channel blocker approved for the improvement of walking in people with multiple sclerosis (MS). This was demonstrated by an increase in walking speed. Ampyra™, was previously referred to as Fampridine-SR, is an extended release tablet formulation of dalfampridine (4-aminopyridine or 4-AP), which was previously called fampridine. In laboratory studies, fampridine has been found to improve impulse conduction in nerve fibers in which the insulating layer, called myelin, has been damaged. Ampyra™ was developed using Elan Drug Technologies Oral Controlled Release MXDAS™(MatriX Drug Absorption System) technology and will be marketed in the United States by Acorda Therapeutics and by Biogen Idec in markets outside the U.S. Ampyra™ is manufactured globally by Elan Pharma International Limited, Ireland, a subsidiary of Elan Corporation, plc at its Athlone, Ireland facility.

About Elan Drug Technologies

Elan Drug Technologies (EDT) a leader in drug delivery is a business unit of Elan Corporation, plc. EDT developed the sustained release formulation of dalfampridine, using one of its Oral Controlled Release Technologies, the MXDAS™ (MatriX Drug Absorption System) technology. Elan Drug Technologies offers clients drug delivery expertise with a suite of commercially launched, proprietary, technology-driven solutions, from NanoCrystal® technology for poorly water soluble compounds, to customised oral controlled release drug technologies. EDT aims to deliver clinically meaningful benefits to patients by using its extensive experience and proprietary delivery technologies in collaboration with pharmaceutical companies. Products enabled by EDT technologies are used by millions of patients each day.  More information is available at www.elandrugtechnologies.com

About Acorda Therapeutics

Acorda Therapeutics is a biotechnology company developing therapies for multiple sclerosis, spinal cord injury and related nervous system disorders. The Company's products include Ampyra™ (dalfampridine), a potassium channel blocker approved for the improvement of walking in adults with multiple sclerosis (MS), this was demonstrated by an improvement in walking speed; and ZANAFLEX CAPSULES® (tizanidine hydrochloride), a short-acting drug for the management of spasticity. The Company's pipeline includes a number of products in development for the treatment, regeneration and repair of the spinal cord and brain.
 
Ampyra™ and Zanaflex Capsules® are trademarks of Acorda Therapeutics Inc
MXDAS™ and NanoCrystal® are  trademarks of Elan Pharma International Limited, Ireland, a subsidiary of Elan Corporation plc (NYSE:ELN).

Safe Harbour/Forward-Looking Statements
The statements in this press release that are not historical facts are forward-looking statements that involve risks and uncertainties. A further list and description of risks, uncertainties and other matters that confront us can be found in our Annual Report on Form 20-F for the fiscal year ended December 31, 2008, and in our Reports of Foreign Issuer on Form 6-K filed with the U.S. Securities and Exchange Commission. We assume no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.

Source: Elan Corporation, plc

Using Elan Drug Technologies MXDAS(TM) technology, AMPYRA(TM) was developed using a hydrophilic matrix, which controlled the rate of release of dalfampridine through a process of diffusion and erosion in the gastrointestinal tract. Using this technology, consistent therapeutic blood levels can be achieved throughout the dosing period and side effects associated with the immediate release formulations of the drug are potentially reduced. AMPYRA(TM) is the first New Drug Application (NDA) approved by the FDA for a product using the MXDAS(TM) technology.

"We wish to congratulate Acorda Therapeutics on the approval of AMPYRA(TM), which will bring a very important and much needed therapy to the market for MS sufferers," announced Shane Cooke, Executive Vice President and Head of Elan Drug Technologies. "This is the second product on which we have worked with Acorda and represents another significant milestone in our successful collaboration with them. It also marks the second product approved by the FDA in the last six months incorporating our technologies and reinforces our position of leadership in drug delivery."

This is the first medicine approved by the FDA indicated to improve walking speed in people with MS. The approval and subsequent launch of AMPYRA(TM) therefore may represent an important new addition to MS therapy. Approximately 400,000-500,000 people in the United States have MS, and recent studies indicate that between 64-85% of people with MS have walking disability. Some 70% of people with MS who have walking disability report it to be the most challenging aspect of their disease.

"We are very proud to announce the approval of AMPYRA(TM) and we thank Elan for their collaboration throughout the development program for this drug. Elan's expertise in formulation development, which resulted in this extended-release tablet, was a critical component of the AMPYRA(TM) clinical program," stated Ron Cohen, MD., President and CEO of Acorda. "Elan has shared our commitment to bringing important new therapies to the market to improve the lives of people with MS throughout the decade we have worked together and we look forward to continuing to find opportunities to work together in the future."

AMPYRA(TM) will be manufactured by Elan at its Athlone, Ireland facility, based on an existing supply agreement with Acorda.

About AMPYRA(TM)

AMPYRA(TM) is a potassium channel blocker approved for the improvement of walking in people with multiple sclerosis (MS). This was demonstrated by an increase in walking speed. AMPYRA(TM), was previously referred to as Fampridine-SR, is an extended release tablet formulation of dalfampridine (4-aminopyridine or 4-AP), which was previously called fampridine. In laboratory studies, fampridine has been found to improve impulse conduction in nerve fibers in which the insulating layer, called myelin, has been damaged. AMPYRA(TM) was developed using Elan Drug Technologies Oral Controlled Release MXDAS(TM)(MatriX Drug Absorption System) technology and will be marketed in the United States by Acorda Therapeutics and by Biogen Idec in markets outside the U.S. AMPYRA(TM) is manufactured globally by Elan Pharma International Limited, Ireland, a subsidiary of Elan Corporation, plc at its Athlone, Ireland facility.

About Elan Drug Technologies

Elan Drug Technologies (EDT) a leading drug delivery company is a business unit of Elan Corporation, plc. EDT developed the sustained release formulation of dalfampridine, using one of its Oral Controlled Release Technologies, the MXDAS(TM) (MatriX Drug Absorption System) technology. Elan Drug Technologies offers clients drug delivery expertise with a suite of commercially launched, proprietary, technology-driven solutions, from NanoCrystal(R) technology for poorly water soluble compounds, to customised oral controlled release drug technologies. EDT aims to deliver clinically meaningful benefits to patients by using its extensive experience and proprietary delivery technologies in collaboration with pharmaceutical companies. Products enabled by EDT technologies are used by millions of patients each day. More information is available at www.elandrugtechnologies.com

About Acorda Therapeutics

Acorda Therapeutics is a biotechnology company developing therapies for multiple sclerosis, spinal cord injury and related nervous system disorders. The Company's products include AMPYRA(TM) (dalfampridine), a potassium channel blocker approved for the improvement of walking in adults with multiple sclerosis (MS), this was demonstrated by an improvement in walking speed; and ZANAFLEX CAPSULES(R) (tizanidine hydrochloride), a short-acting drug for the management of spasticity. The Company's pipeline includes a number of products in development for the treatment, regeneration and repair of the spinal cord and brain.

AMPYRA(TM) and Zanaflex Capsules(R) are trademarks of Acorda Therapeutics Inc

MXDAS(TM) and NanoCrystal(R) are trademarks of Elan Pharma International Limited, Ireland, a subsidiary of Elan Corporation, plc.

Safe Harbour/Forward-Looking Statements

The statements in this press release that are not historical facts are forward-looking statements that involve risks and uncertainties. A further list and description of risks, uncertainties and other matters that confront us can be found in our Annual Report on Form 20-F for the fiscal year ended December 31, 2008, and in our Reports of Foreign Issuer on Form 6-K filed with the U.S. Securities and Exchange Commission. We assume no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.

Source:

Elan Corporation, plc
Investors:
Chris Burns, 800-252-3526
Chris.Burns@elan.com
or
David Marshall, 353-1-709-4444
David.Marshall@elan.com
or
Media:
Miriam Mason, 650-278-7113 (onsite)
Miriam.Mason@elan.com
or
Mary Stutts, 650-794-4403
Mary.Stutts@elan.com

"From the beginning, Elan has very much led the way in drug delivery with innovative solutions that have addressed real patient needs, which have consequently hugely benefited the pharmaceutical industry," said Shane Cooke, Executive Vice President and Head of Elan Drug Technologies. "It is with great pride that we celebrate 40 years at the forefront of the drug delivery industry and our position as the world’s leading drug delivery company.  We thank our employees, customers and associates who have been a part of our success through the years.”

Some major milestones of note:

• Elan becomes the first Irish company listed on the American Stock Exchange 
• Elan’s SODAS® technology is applied to one of the first pharmaceutical blockbuster products - the Cardizem® franchise in the US in the 1980’s and 1990’s
• TriCor®145, Abbott’s anti-cholesterol product, which incorporated Elan’s NanoCrystal® technology, achieves over $1B annual in-market sales.

Since 2001, 11 products have been approved and launched in the US alone incorporating its technologies, making Elan Drug Technologies, in terms of product launches, the most successful drug delivery company of the decade.  To date Elan’s drug delivery technologies have been commercialised in 35 products in more than 100 countries worldwide, contributing to client sales of over $2.7 billion in 2008 alone.  This year has seen the approval and launch of Janssen’s Invega® Sustenna™, bringing to five the number of licensed products launched using Elan’s NanoCrystal® technology. In October, Merck/Ono’s product EMEND® was approved in Japan, the first NanoCrystal® technology-based product approved by Japanese health authorities.   Acorda Therapeutics Fampridine-SR product, which is currently under review by the US Food and Drug Administration (FDA), was developed using Elan’s MXDAS™ hydrophilic matrix technology.  Fampridine-SR’s Prescription Drug User Fee Act (PDUFA) date is set for January 22nd 2010. 

Throughout its 40 years in business, Elan Drug Technologies has remained committed to using its extensive experience, drug delivery technologies and commercial capabilities to help clients develop innovative products that provide clinically meaningful benefits to patients.  Committed to innovation - whether in the products developed, advancing its existing technologies or developing new technologies, EDT has been driven by some of the best scientific talent in the area of drug delivery formulation. With 14 pipeline products in the clinic, multiple preclinical programmes and a strong client base, Elan Drug Technologies plans to maintain its position as the leading drug delivery company worldwide.

About Elan Drug Technologies

Elan Drug Technologies (EDT) is the world’s leading drug delivery company and is a business unit of Elan (NYSE:ELN). As a fully integrated drug delivery business, EDT delivers clinically meaningful benefits to patients, by using its extensive experience and proprietary delivery technologies in partnership with pharmaceutical companies to develop new and innovative products. From NanoCrystal® technology for poorly water soluble compounds, to customised oral drug technologies, EDT offers clients unrivalled drug delivery expertise with a suite of commercially launched, proprietary, technology-driven solutions. With 40 years experience in the drug delivery business, EDT has successfully brought 35 products to market for clients in over 100 markets worldwide. EDT has extensive product development, scale-up and manufacturing capabilities in the US and EU and a suite of over 1,900 patents/pending patents protecting its technology-based solutions. Products enabled by EDT technologies are used by millions of patients each day.  More information is available at www.elandrugtechnologies.com

Safe Harbour/Forward-Looking Statements
The statements in this release that are not historical facts are forward-looking statements that involve risks and uncertainties. A further list and description of the risks, uncertainties and other matters that confront us can be found in our Annual Report on Form 20-F for the fiscal year ended December 31, 2008, and in our Reports of Foreign Issuer on Form 6-K filed with the U.S. Securities and Exchange Commission. We assume no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.

Source: Elan Corporation, plc

NanoCrystal® technology, enables formulation of poorly water soluble compounds for all routes of administration. For EMEND®, this technology advance eliminates a food requirement and improves bioavailability by 600%.  EMEND®  was confirmed to be effective for both acute and delayed phases of nausea and vomiting in Japanese clinical trials, and becomes the first therapy  approved for treatment of  delayed phase nausea and vomiting (24 hours or later after start of cancer chemotherapy) in Japan.

 “The approval of EMEND® is a significant achievement for our NanoCrystal® technology, as it marks the first Japanese approval of a product incorporating this technology in this very important market”, said Shane Cooke, Executive Vice President and Head of Elan Drug Technologies. “We hope this is the first of many products using our NanoCrystal® technology to be launched in Japan.”

NanoCrystal® technology is a proprietary technology developed by Elan Drug Technologies through Elan Pharma International Limited and other Elan affiliates. Five licensed products have now been approved using the NanoCrystal® technology by various health authorities including the US Food and Drug Administration (FDA). Products incorporating the NanoCrystal® technology are sold in markets worldwide.

About Elan Drug Technologies and NanoCrystal® Technology
Elan Drug Technologies (EDT), one of the world’s leading drug delivery businesses, is a business unit of Elan Corporation plc.  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 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 NanoCrystal® technology for poorly water soluble compounds, to customised oral controlled release drug technologies. Products enabled by its technologies are used by millions of patients each day.  For more information go to www.elandrugtechnologies.com
 
 

NanoCrystal® is a registered trademark of Elan Pharma International Limited, Ireland, a subsidiary of Elan Corporation plc.
EMEND® is a registered trademark of Merck & Co Inc.

Safe Harbour/Forward-Looking Statements
The statements in this press release that are not historical facts are forward-looking statements that involve risks and uncertainties. A further list and description of the risks, uncertainties and other matters that confront us can be found in our Annual Report on Form 20-F for the fiscal year ended December 31, 2008, and in our Reports of Foreign Issuer on Form 6-K filed with the U.S. Securities and Exchange Commission. We assume no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.

Source: Elan Corporation, plc

Elan Corporation, plc
Investors:
Chris Burns, 800-252-3526
Chris.Burns@elan.com
or
David Marshall, 353-1-709-4444
David.Marshall@elan.com
or
Media:
Miriam Mason, 650-278-7113 (onsite)
Miriam.Mason@elan.com
or
Mary Stutts, 650-794-4403
Mary.Stutts@elan.com

The NanoCrystal® technology, a technology enabling the formulation of poorly water soluble compounds for all routes of administration, facilitated the development of a stable, low viscosity, high drug loaded formulation of paliperidone palmitate. The application of the NanoCrystal® technology has allowed for a ready-to-use one month duration intramuscular injectable formulation to be developed. This product was approved by the US Food and Drug Administration (FDA) earlier this year.

About Elan Drug Technologies and NanoCrystal® technology
Elan Drug Technologies (EDT), the world’s leading drug delivery businesses, is a business unit of Elan (NYSE:ELN).  As a fully integrated drug delivery business, Elan Drug Technologies develops products that deliver clinically meaningful benefits to patients, by using its extensive experience and proprietary delivery technologies in collaboration with pharmaceutical companies. For 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 offers clients drug delivery expertise with a suite of commercially launched, proprietary, technology-driven solutions, from NanoCrystal® technology for poorly water soluble compounds, to customised oral controlled release drug technologies. Products enabled by these technologies are used by millions of patients each day. For more information go to www.elandrugtechnologies.com

NanoCrystal® is a registered trademark of Elan Pharma International Limited, Ireland, a subsidiary of Elan Corporation plc (NYSE:ELN).
 

Safe Harbour/Forward-Looking Statements
The statements in this press release that are not historical facts are forward-looking statements that involve risks and uncertainties. A further list and description of the risks, uncertainties and other matters that confront us can be found in our Annual Report on Form 20-F for the fiscal year ended December 31, 2008, and in our Reports of Foreign Issuer on Form 6-K filed with the U.S. Securities and Exchange Commission. We assume no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.

Source: Elan Corporation, plc

Elan Corporation, plc
Investors:
Chris Burns, 800-252-3526
Chris.Burns@elan.com
or
David Marshall, 353-1-709-4444
David.Marshall@elan.com
or
Media:
Miriam Mason, 650-278-7113 (onsite)
Miriam.Mason@elan.com
or
Mary Stutts, 650-794-4403
Mary.Stutts@elan.com

Fifth product approved by the US FDA licensing Elan’s NanoCrystal® technology for various formulations

DUBLIN, IRELAND, August 3rd 2009, Elan Drug Technologies, a business unit of Elan Corporation, plc (NYSE: ELN) announces the first approval of a long acting injectable formulation using Elan Drug Technologies’ proprietary NanoCrystal® technology.

Late last week, Janssen, a division of Ortho-McNeil-Janssen Pharmaceuticals, announced the approval of INVEGA® SUSTENNA™, the first once monthly atypical antipsychotic injection, by the United States Food and Drug Administration.

“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, a technology enabling the formulation of poorly water soluble compounds for all routes of administration, 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.  

About Elan Drug Technologies and NanoCrystal® technology
Elan Drug Technologies (EDT), one of the world’s leading drug delivery businesses, is a business unit of Elan (NYSE:ELN).  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 almost 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 NanoCrystal® technology for poorly water soluble compounds, to customised oral controlled release drug technologies. Products enabled by their technologies are used by millions of patients each day. For more information go to www.elandrugtechnologies.com

Important Safety Information For INVEGA® SUSTENNA™
Visit http://www.INVEGASUSTENNA.com for full prescribing information.

INVEGA® SUSTENNA™ is a trademark of Johnson & Johnson family of companies.
NanoCrystal® is a registered trademark of Elan Pharma International Limited, Ireland, a subsidiary of Elan Corporation plc (NYSE:ELN).
 

Safe Harbour/Forward-Looking Statements
The statements in this press release that are not historical facts are forward-looking statements that involve risks and uncertainties. A further list and description of the risks, uncertainties and other matters that confront us can be found in our Annual Report on Form 20-F for the fiscal year ended December 31, 2008, and in our Reports of Foreign Issuer on Form 6-K filed with the U.S. Securities and Exchange Commission. We assume no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.

Source: Elan Corporation, plc

Elan Corporation, plc
Investors:
Chris Burns, 800-252-3526
Chris.Burns@elan.com
or
David Marshall, 353-1-709-4444
David.Marshall@elan.com

or
Media:
Miriam Mason, 650-278-7113 (onsite)
Miriam.Mason@elan.com
or
Mary Stutts, 650-794-4403
Mary.Stutts@elan.com
 

Acorda to Continue to Develop and Commercialize Fampridine-SR in the U.S. Upfront Payment of $110 Million; Potential Deal Value Over $500 Million Acorda to Host Conference Call at 8:30 a.m. Eastern Time Today

CAMBRIDGE, Ma. & HAWTHORNE, N.Y.--(BUSINESS WIRE)--Jul. 1, 2009-- Biogen Idec (NASDAQ:BIIB) and Acorda Therapeutics, Inc. (NASDAQ:ACOR) today announced that they have entered into an exclusive collaboration and license agreement to develop and commercialize Fampridine-SR, a multiple sclerosis (MS) therapy, in markets outside the United States. Fampridine-SR is a novel, oral sustained-release compound being developed to improve walking ability in people with MS. The parties have also entered into a related supply agreement. The transaction represents a sublicensing of an existing license agreement between Acorda and Elan Pharma International Limited, a subsidiary of Elan Corporation plc (NYSE:ELN).
 

Under the terms of the agreement, Biogen Idec will commercialize Fampridine-SR and any aminopyridine products developed under the agreement in ex-U.S. markets worldwide and will also have responsibility for regulatory activities and future clinical development of Fampridine-SR in those markets. Acorda will receive an upfront payment of $110 million and additional payments of up to $400 million based on the successful achievement of future regulatory and sales milestones. Biogen Idec will make tiered, double-digit royalty payments to Acorda on ex-U.S. sales, and, in addition, the consideration that Biogen Idec pays for products will reflect all amounts due from Acorda to Elan for ex-US sales, including royalties owed. The parties can also carry out future joint development activities under a cost-sharing arrangement.
 

Elan will continue to manufacture commercial supply of Fampridine-SR, based on its existing supply agreement with Acorda. Under the existing agreements with Elan, Acorda will pay Elan seven percent of the upfront and milestone payments that Acorda receives from Biogen Idec.
 

“Biogen Idec has outstanding capabilities in commercializing neurology and oncology products and is known globally for its reputation as an innovative leader in the field of multiple sclerosis. We are delighted to be working with them to make Fampridine-SR, if approved, available to people living with MS in Europe, Canada, Australia and other areas of the world,” said Ron Cohen, M.D., President and CEO of Acorda. “We believe that Biogen Idec’s international expertise in MS and neurology also will help us optimize future development of Fampridine-SR and maximize its value in markets outside the U.S.”
 

“We are very pleased to partner with Acorda, a leader in the development of therapies for spinal cord, MS, and related nervous system disorders, to help make Fampridine-SR available to MS patients outside of the United States,” said Jim Mullen, President and CEO of Biogen Idec. “As we look to expand our global MS leadership, we believe Fampridine-SR has the potential to become an important oral therapy that may help improve the walking ability of a wide range of patients – including patients with relapsing forms of MS, as well as primary and secondary progressive MS.”
 

MS is a chronic disease of the central nervous system that affects approximately two million people worldwide.
 

Acorda previously announced that the European Medicines Agency (EMEA) notified the Company that Fampridine-SR is eligible to be submitted for a Marketing Authorization Application (MAA) via the Agency’s Centralized Procedure as a new active substance. The Centralized Procedure provides for a single, coordinated review that is conducted by the EMEA on behalf of all European Union (EU) member states.
 

Acorda will continue to develop and commercialize Fampridine-SR independently in the U.S. The U.S. Food and Drug Administration (FDA) is currently reviewing a New Drug Application (NDA) for Fampridine-SR. The NDA was assigned Priority Review and a Prescription Drug User Fee Act (PDUFA) date of October 22, 2009; the PDUFA date is the target date for the FDA to complete its review of Fampridine-SR.
 

Conference Call and Audiocast

Ron Cohen, President and Chief Executive Officer of Acorda Therapeutics, will host a conference call today at 8:30 a.m. ET.
 

To participate in the conference call, please dial 800-706-7745 (domestic) or 617-614-3472 (international) and reference the access code 68235234. The presentation will be available via a live webcast at
http://phx.corporate-ir.net/phoenix.zhtml?p=irol-eventDetails&c=194451&eventID=2303543.
 

A replay of the call will be available from 11:30 a.m. ET on July 1, 2009 until midnight on August 1, 2009. To access the replay, please dial 888-286-8010 (domestic) or 617-801-6888 (international) and reference the access code 96152771. The archived webcast will be available for 30 days in the Investor Relations section of the Acorda website at http://www.acorda.com.
 

About Fampridine-SR

Fampridine-SR is a sustained-release tablet formulation of the investigational drug fampridine (4-aminopyridine or 4-AP). Fampridine has completed two successful Phase 3 clinical trials demonstrating improved walking ability in people with MS. It has been found to improve impulse conduction in nerve fibers in which the insulating layer, called myelin, has been damaged. Fampridine-SR was developed using Elan’s proprietary Oral Controlled Release MXDAS™ (MatriX Drug Absorption System) Technology and will be manufactured by Elan based on an existing supply agreement with Acorda.
 

About Acorda Therapeutics

Acorda Therapeutics is a biotechnology company developing therapies for spinal cord injury, multiple sclerosis and related nervous system disorders. The Company's marketed products include Zanaflex Capsules® (tizanidine hydrochloride), a short-acting drug for the management of spasticity. The Company's pipeline includes a number of products in development for the treatment, regeneration and repair of the spinal cord and brain.

About Biogen Idec

Biogen Idec creates new standards of care in therapeutic areas with high unmet medical needs. Founded in 1978, Biogen Idec is a global leader in the discovery, development, manufacturing, and commercialization of innovative therapies. Patients in more than 90 countries benefit from Biogen Idec's significant products that address diseases such as lymphoma, multiple sclerosis, and rheumatoid arthritis. For product labeling, press releases and additional information about the company, please visit www.biogenidec.com

About Elan Drug Technologies

Elan Drug Technologies (EDT) is the world’s leading drug delivery provider and is a business unit of Elan Corporation plc. EDT developed Fampridine-SR, using one of their proprietary Oral Controlled Release Technologies, the MXDAS™ (MatriX Drug Absorption System) Technology. Products are developed by EDT through Elan Pharma International Limited and other Elan affiliates. EDT aims to deliver clinically meaningful benefits to patients by using their extensive experience and proprietary delivery technologies in partnership with pharmaceutical companies. More information is available at www.elandrugtechnologies.com
 

Forward-Looking Statements

This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, regarding management's expectations, beliefs, goals, plans or prospects should be considered forward-looking. These statements are subject to risks and uncertainties that could cause actual results to differ materially, including delays in obtaining or failure to obtain regulatory approval of Fampridine-SR, the risk of unfavorable results from future studies of Fampridine-SR, adverse safety events, dependence on a third party to supply Fampridine-SR, Acorda Therapeutics' and Biogen Idec’s ability to successfully market and sell Fampridine-SR, if approved, competitive pressures, the availability of reimbursement from third party payors, failure to protect intellectual property or to defend against the intellectual property claims of others, and Acorda Therapeutics’ ability to obtain additional financing to support its operations.. These and other risks are described in greater detail in Acorda Therapeutics' and Biogen Idec’s respective filings with the Securities and Exchange Commission. Acorda Therapeutics and Biogen Idec may not actually achieve the goals or plans described in any forward-looking statements included in this press release, and investors should not place undue reliance on these statements. Any forward-looking statements speak only as of the date of this press release. Acorda Therapeutics and Biogen Idec disclaim any intent or obligation to update any forward-looking statements as a result of developments occurring after the date of this press release.
 

Photos/Multimedia Gallery Available: http://www.businesswire.com/cgi-bin/mmg.cgi?eid=5998434&lang=en
 

Source: Acorda Therapeutics, Inc. & Biogen Idec
Acorda Therapeutics:
Jeff Macdonald, 914-347-4300 ext. 232
jmacdonald@acorda.com
or
Biogen Idec:
Media:
Jennifer Neiman, 617-914-6524
or
Investor:
Eric Hoffman, 617-679-2812

“I am pleased that we were able to work quickly to address the comments from the FDA and resubmit our NDA approximately three weeks from having received the Refuse to File letter on our initial NDA submission, and that the FDA accepted the filing less than two weeks later,” said Ron Cohen, M.D., Acorda Therapeutics’ President and CEO. “We are also encouraged that the FDA has elected to assign Priority Review status to the Fampridine-SR NDA.”
 

About Fampridine-SR

Fampridine-SR is a sustained-release tablet formulation of the investigational drug fampridine (4-aminopyridine or 4-AP). In laboratory studies, fampridine has been found to improve impulse conduction in nerve fibers in which the insulating layer, called myelin, has been damaged. Fampridine-SR is being developed by Acorda Therapeutics and manufactured by Elan Corporation plc.
 

About Acorda Therapeutics

Acorda Therapeutics is a biotechnology company developing therapies for spinal cord injury, multiple sclerosis and related nervous system disorders. The Company's marketed products include Zanaflex Capsules® (tizanidine hydrochloride), a short-acting drug for the management of spasticity. The Company's pipeline includes a number of products in development for the treatment, regeneration and repair of the spinal cord and brain.
 

About Elan Drug Technologies

Elan Drug Technologies (EDT) is the world’s leading drug delivery company and is a business unit of Elan (NYSE: ELN). EDT developed Fampridine-SR, using one of their proprietary Oral Controlled Release Technologies, the MXDAS® (MatriX Drug Absorption System) Technology. Products developed by EDT aim to deliver clinically meaningful benefits to patients by using their extensive experience and proprietary delivery technologies in partnership with pharmaceutical companies. More information is available at www.elandrugtechnologies.com
 

Forward-Looking Statements

This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, regarding management's expectations, beliefs, goals, plans or prospects should be considered forward-looking. These statements are subject to risks and uncertainties that could cause actual results to differ materially, including delays in obtaining or failure to obtain FDA approval of Fampridine-SR, the risk of unfavorable results from future studies of Fampridine-SR, Acorda Therapeutics' ability to successfully market and sell Fampridine-SR, if approved, and Zanaflex Capsules, competition, failure to protect its intellectual property or to defend against the intellectual property claims of others, the ability to obtain additional financing to support Acorda Therapeutics' operations, and unfavorable results from its preclinical programs. These and other risks are described in greater detail in Acorda Therapeutics' filings with the Securities and Exchange Commission. Acorda Therapeutics may not actually achieve the goals or plans described in its forward-looking statements, and investors should not place undue reliance on these statements. Acorda Therapeutics disclaims any intent or obligation to update any forward-looking statements as a result of developments occurring after the date of this press release.
 

Source: Acorda Therapeutics, Inc.
 

Acorda Therapeutics
Jeff Macdonald, 914-347-4300 ext. 232
jmacdonald@acorda.com

About Acorda Therapeutics

Acorda Therapeutics is a biotechnology company developing therapies for spinal cord injury, multiple sclerosis and related nervous system disorders. The Company's marketed products include Zanaflex Capsules® (tizanidine hydrochloride), a short-acting drug for the management of spasticity. The Company's pipeline includes a number of products in development for the treatment, regeneration and repair of the spinal cord and brain.
 

Forward-Looking Statements

This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, regarding management's expectations, beliefs, goals, plans or prospects should be considered forward-looking. These statements are subject to risks and uncertainties that could cause actual results to differ materially, including delays in obtaining or failure to obtain FDA approval of Fampridine-SR, the risk of unfavorable results from future studies of Fampridine-SR, Acorda Therapeutics' ability to successfully market and sell Fampridine-SR, if approved, and Zanaflex Capsules, competition, failure to protect its intellectual property or to defend against the intellectual property claims of others, the ability to obtain additional financing to support Acorda Therapeutics' operations, and unfavorable results from its preclinical programs. These and other risks are described in greater detail in Acorda Therapeutics' filings with the Securities and Exchange Commission. Acorda Therapeutics may not actually achieve the goals or plans described in its forward-looking statements, and investors should not place undue reliance on these statements. Acorda Therapeutics disclaims any intent or obligation to update any forward-looking statements as a result of developments occurring after the date of this press release.
 

Source: Acorda Therapeutics, Inc.
 

Acorda Therapeutics
Jeff Macdonald, 914-347-4300 ext. 232
jmacdonald@acorda.com
 

HAWTHORNE, N.Y.--(BUSINESS WIRE)--)--February 02, 2009-- Acorda Therapeutics, Inc. (Nasdaq: ACOR) today announced the submission of a New Drug Application to the U.S. Food and Drug Administration (FDA) on January 30, 2009 for Fampridine-SR, a novel therapy being developed to improve walking ability in people with multiple sclerosis (MS). The Company expects that the NDA filing, if accepted, will be subject to standard review, which would provide a target for the FDA to complete its review within ten months from receipt of the submission.

“This NDA filing is a major milestone for Acorda and our Fampridine-SR development program,” said Acorda Therapeutics President and CEO Ron Cohen, M.D. “Walking impairment is one of the most pervasive and alarming aspects of MS for patients, their families and their health care providers. There are no medicines currently indicated to improve walking ability in people with MS, and Fampridine-SR therefore may represent an important new approach to MS therapy. We are excited to have taken this major step toward potentially making Fampridine-SR available to help people with MS.”
 

Approximately 400,000-500,000 people in the Unites States have MS, and recent studies indicate that between 64-85% of people with MS have walking disability¹,². Fully 70% of people with MS who have walking disability report it to be the most challenging aspect of their disease¹.

The Fampridine-SR NDA submission is based on data from a comprehensive development program assessing the safety and efficacy of Fampridine-SR, including two Phase 3 trials that involved 540 people with MS and were conducted under Special Protocol Assessments (SPAs) from the FDA. The safety and efficacy profile of Fampridine-SR was consistent across Phase 2 and Phase 3 trials. Overall, the NDA filing included more that 50 clinical studies of Fampridine-SR. The total exposure to Fampridine-SR in MS studies filed as part of the NDA was over 1,200 patient-years. Additionally, more than 450 people are currently enrolled in Fampridine-SR extension trials, with treatment duration ranging from seven months to almost five years.
 

The Company also has discussed Fampridine-SR with regulatory authorities in Europe and believes that the current data are sufficient to file a centralized Marketing Authorization Application (MAA) with the European Medicines Agency (EMEA). The Company plans to file the MAA when it has determined the commercialization pathway that maximizes the value of Fampridine-SR outside the U.S.
 

About Fampridine-SR

Fampridine-SR is a sustained-release tablet formulation of the investigational drug fampridine (4-aminopyridine or 4-AP). In laboratory studies, fampridine has been found to improve impulse conduction in nerve fibers in which the insulating layer, called myelin, has been damaged. As of June 2008, the Company completed two successful Phase 3 clinical trials to evaluate the safety and efficacy of Fampridine-SR in improving walking ability in people with MS.
 

About Acorda Therapeutics

Acorda Therapeutics is a biotechnology company developing therapies for spinal cord injury, multiple sclerosis and related nervous system disorders. The Company's marketed products include Zanaflex Capsules^® (tizanidine hydrochloride), a short-acting drug for the management of spasticity. In June 2008, Acorda's lead clinical product, Fampridine-SR, completed a second Phase 3 clinical trial to evaluate its safety and efficacy in improving walking ability in people with MS. The Company's pipeline includes a number of products in development for the treatment, regeneration and repair of the spinal cord and brain.
 

Forward-Looking Statement

This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, regarding management's expectations, beliefs, goals, plans or prospects should be considered forward-looking. These statements are subject to risks and uncertainties that could cause actual results to differ materially, including delays in obtaining or failure to obtain FDA approval of Fampridine-SR, the risk of unfavorable results from future studies of Fampridine-SR, Acorda Therapeutics' ability to successfully market and sell Fampridine-SR, if approved, and Zanaflex Capsules, competition, failure to protect its intellectual property or to defend against the intellectual property claims of others, the ability to obtain additional financing to support Acorda Therapeutics' operations, and unfavorable results from its preclinical programs. These and other risks are described in greater detail in Acorda Therapeutics' filings with the Securities and Exchange Commission. Acorda Therapeutics may not actually achieve the goals or plans described in its forward-looking statements, and investors should not place undue reliance on these statements. Acorda Therapeutics disclaims any intent or obligation to update any forward-looking statements as a result of developments occurring after the date of this press release.

¹ Harris Interactive poll, April 2008
² NARCOMS patient database
 

Source: Acorda Therapeutics, Inc.
 

Acorda Therapeutics
Jeff Macdonald, 914-347-4300 ext. 232
jmacdonald@acorda.com
 

About Azur Pharma

Azur is a privately held pharmaceutical company dedicated to enhancing patients' lives by developing and marketing pharmaceutical products in specialist therapeutic areas. Azur's strategy is to identify, evaluate, selectively acquire and enhance the value of late stage development and approved pharmaceutical products. (Website: www.azurpharma.com)

NanoCrystal® Technology is a registered trademark of Elan Pharma International Limited, Ireland. For more information on Elan’s drug delivery technologies including the NanoCrystal® Technology, please visit www.elan.com/EDT

Media Contact
Mr. Ray Gordon, MRPA Kinman Communications
Telephone: +353-1-7038619/+353-87-2417373
E-mail: ray@mrpakinman.ie

• Only Focalin XR provided onset of effect as early as 30 minutes post-dose
• Additional analysis suggests Focalin XR provides comparable efficacy to Concerta over 12 hours
• Symptoms of Attention Deficit/Hyperactivity Disorder (ADHD) can significantly impact a child's ability to focus and learn in an educational setting 

EAST HANOVER, N.J., July 8 /PR Newswire/ -- A head-to-head study, published in the June Journal of Child and Adolescent Psychopharmacology, confirms that Focalin® XR (dexmethylphenidate HCl) extended-release capsules offer greater improvements in managing symptoms of Attention Deficit/Hyperactivity Disorder compared with Concerta® (d,l- methylphenidate HCl) extended-release tablets at two hours post-dose, the primary study endpoint.

Focalin XR 20 mg and 30 mg2 also demonstrated better symptom control versus Concerta 36 mg and 54 mg respectively, from 30 minutes to 6 hours. Symptom control was demonstrated as early as 30 minutes post-dose with Focalin XR 20 mg and 30 mg versus placebo. Neither dose of Concerta was effective versus placebo at 30 minutes. Novartis is seeking revised labeling to reflect the 30-minute onset of action.

"There are many things to consider when determining which treatment is best for a patient, including lifestyle implications," said Alice Mao, M.D., Associate Professor of Psychiatry at the Baylor College of Medicine. "The results of this study demonstrate the benefits of Focalin XR during the early part of the day, which may be better for children who need their medication to begin working before they leave for school and continue working throughout the day.

Attention Deficit/Hyperactivity Disorder affects approximately three to seven percent of children in the United States, and its symptoms -- inattention, hyperactivity and impulsivity -- can significantly impact a child's ability to focus and learn in an educational setting. The study included children between the ages of 6 and 12 and examined their response to Focalin XR compared to Concerta as well as placebo in a classroom setting.

Similar efficacy was observed between Focalin XR and Concerta at eight hours post-dose. Only at 10 to 12 hours and 11 to 12 hours post-dose did Concerta 36 mg and 54 mg demonstrate symptom improvement over Focalin XR 20 mg and 30 mg respectively.

"Focalin XR helps children with ADHD optimize their natural cycle of the day because its drug delivery system allows for a quick onset in the morning, effective symptom management during the day, and then tapers off in the evening," said Rafael Muniz, MD, Senior Medical Director, Novartis Pharmaceuticals Corporation.

Focalin XR uses the proprietary SODAS® (Spheroidal Oral Drug Absorption System) technology developed by Elan Corporation, where 50% of the dose is released immediately and the remaining 50% is released after approximately four hours, resulting in a maximum peak at about 1.5 hours and a second peak at about 6.5 hours. Concerta is formulated to release 22% of the drug initially, with the remainder released through a controlled osmotic process.

In addition, Focalin XR and Concerta have chemical differences. Focalin XR isolates the active d-isomer of d,l-methylphenidate. Therefore, only half the dose of methylphenidate is required. Concerta is a d,l-methylphenidate.


Study Results

The randomized, multi-center, double-blind, five-period, crossover study was conducted in 84 children with ADHD with 6-12 years of age, stabilized on methylphenidate and randomized to different treatment sequences for comparison. The study was conducted in a laboratory classroom setting over a 12 hour period. The crossover design exposed each child to five treatments: Focalin XR (20 mg/day and 30 mg/day), Concerta (36 mg/day and 54 mg/day) and placebo

Primary efficacy was measured by the change from pre-dose in the Swanson, Kotkin, Agler, Mylnn, and Pelham (SKAMP) Rating Scale-Combined scores at two hours post-dose with Focalin XR 20 mg compared with Concerta 36 mg. The SKAMP rating scale is a standard assessment tool used in laboratory classroom clinical trials to evaluate attention and behavior.

Both doses of Focalin XR showed significantly greater improvement in SKAMP-Attention and -Deportment scores when compared with placebo at all measured time-points (30 minutes to 12 hours post-dose), except for 10-12 hours post-dose with 20 mg. Concerta 36 mg and 54 mg demonstrated efficacy at measured time-points 1-12 hours post-dose, but were no different to placebo at 30 minutes.

Because of the differences in release profiles, the investigators also studied overall efficacy during the 12 hour study period using an area under the curve analysis (AUC0-12) of the SKAMP combined scores. All doses of the active medication were significantly better than placebo. There was no difference between Focalin XR 20 mg and 30 mg when compared to both Concerta 36 mg and 54 mg, respectively, observed overall across the 12-hour day.

In general, both treatments were well tolerated and no patients discontinued or had a reduction in study drug dose due to an adverse event. A total of 81 children completed the study (three withdrew consent for reasons not related to study medications).

A previous head-to-head study comparing Focalin XR and Concerta published in the April 2008 Psychopharmacology Bulletin found similar efficacy and safety results to the present study.


About Focalin XR

Focalin XR (dexmethylphenidate HCl) extended-release capsules are indicated for the treatment of Attention Deficit/Hyperactivity Disorder (ADHD) in adults, adolescents and children six years and older. Focalin XR is indicated as an integral part of a total treatment program for ADHD that may include other measures (e.g., psychological, educational, social) for patients with this syndrome.

 
Important Safety Information

The most common adverse events seen with Focalin XR were dyspepsia, decreased appetite, headache and anxiety in pediatric studies; and dry mouth, dyspepsia, feeling jittery, dizziness, headache and anxiety in adult studies.

Focalin XR is contraindicated in patients with marked anxiety, tension and agitation since the drug may aggravate these symptoms; in patients known to be hypersensitive to methylphenidate or other components of the product; in patients with glaucoma; in patients with motor tics or with a family history or diagnosis of Tourette's syndrome; and during or following treatment with monoamine oxidase inhibitors.

Stimulants should generally not be used in children, adolescents or adults with known serious structural cardiac abnormalities, cardiomyopathy, serious heart-rhythm abnormalities or other serious cardiac problems. Use with caution in treating patients with underlying medical conditions that might be compromised by increases in blood pressure or heart rate, such as those with pre-existing hypertension, heart failure, recent myocardial infarction or ventricular arrhythmia. Before initiating treatment, patients should have careful history and physical exam to assess for presence of cardiac disease.

Use with caution in psychosis or bipolar disorder. Discontinuation of treatment may be appropriate in the presence of treatment-emergent psychotic or manic symptoms. While aggressive behavior is often observed in children or adolescents with ADHD, patients beginning treatment should be monitored for the appearance of or worsening of aggressive behavior or hostility.

Suppression of growth has been reported with long-term use of stimulants. Stimulants should be used with caution in patients with a prior history of seizures or EEG abnormalities. Difficulties with accommodation and blurring of vision have been reported with stimulant treatment. (See WARNINGS.)

Focalin XR should be given cautiously to patients with a history of drug dependence or alcoholism. Chronic abusive use can lead to marked tolerance and psychological dependence with varying degrees of abnormal behavior. Frank psychotic episodes can occur, especially with parenteral abuse. Careful supervision is required during drug withdrawal from abusive use since severe depression may occur. Withdrawal following chronic therapeutic use may unmask symptoms of the underlying disorder that may require follow-up.

Please see full Prescribing Information for Focalin XR including Contraindications, Boxed Warning and Medication Guide at http://www.FocalinXR.com or call us at 1-888-NOW-NOVA.

For further information, please visit http://www.FocalinXR.com.


Disclaimer

The foregoing release contains forward-looking statements that can be identified by terminology such as "suggests," "can," "is seeking," "may," or similar expressions, or by express or implied discussions regarding potential additional labeling or indications or potential future sales of Focalin XR. Such forward-looking statements reflect the current views of Novartis regarding future events, and involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no guarantee that Focalin XR will be approved for any additional labeling or indications in any country. Nor can there be any guarantee that Focalin XR will reach any particular sales levels. In particular, management's expectations regarding Focalin XR could be affected by, among other things, unexpected regulatory actions or delays or government regulation generally; unexpected clinical trial results, including unexpected new clinical data, and unexpected additional analysis of existing clinical data; the company's ability to obtain or maintain patent or other proprietary intellectual property protection; competition in general; increased government, industry, and general public pricing pressures; and other risks and factors referred to in Novartis AG's current Form 20-F on file with the U.S. Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those anticipated, believed, estimated or expected. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.


About Novartis

Novartis Pharmaceuticals Corporation researches, develops, manufactures and markets leading innovative prescription drugs used to treat a number of diseases and conditions, including those in the cardiovascular, metabolic, cancer, organ transplantation, central nervous system, dermatological, GI and respiratory areas. The company's mission is to improve people's lives by pioneering novel healthcare solutions.

Located in East Hanover, New Jersey, Novartis Pharmaceuticals Corporation is an affiliate of Novartis AG (NYSE: NVS - News), which provides healthcare solutions that address the evolving needs of patients and societies. Focused solely on growth areas in healthcare, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, cost-saving generic pharmaceuticals, preventive vaccines and diagnostic tools, and consumer health products. Novartis is the only company with leading positions in these areas. In 2007, the Group's continuing operations (excluding divestments in 2007) achieved net sales of USD 38.1 billion and net income of USD 6.5 billion. Approximately USD 6.4 billion was invested in R&D activities throughout the Group. Headquartered in Basel, Switzerland, Novartis Group companies employ approximately 98,000 full-time associates and operate in over 140 countries around the world. For more information, please visit http://www.novartis.com.

 

Novartis Partnerships

Celgene Corporation (Nasdaq: CELG - News) of Summit, New Jersey granted Novartis Pharma AG an exclusive worldwide (excluding Canada) license covering its intellectual property rights associated with Focalin XR. Pursuant to an agreement between Novartis Pharma AG and Novartis Pharmaceuticals Corporation, Novartis Pharmaceuticals Corporation markets Focalin XR in the U.S. Focalin XR was developed with SODAS® technology (spheroidal oral drug absorption system), a multiparticulate drug delivery system of Elan Corporation, plc (NYSE: ELN - News). Focalin XR is being supplied to Novartis under an exclusive worldwide (except Canada) royalty and manufacturing agreement between Elan Corporation, plc, and Novartis Pharma AG.

 
References

   1. Concerta® is a registered trademark of ALZA Corporation.
   2. The 30 mg dose of Focalin XR is not an FDA-approved dosage strength. The maximum approved dose is 20 mg once daily. 


Novartis Media Relations
Gina Moran

Novartis Pharmaceutical Corporation
973-476-3643 (cell)
862-778-5567 (office)
gina.moran@novartis.com
e-mail: media.relations@novartis.com

Novartis Investor Relations
Ruth Metzler-Arnold: +41 61 324 9980
Katharina Ambuehl: +41 61 324 5316
Pierre-Michel Bringer: +41 61 324 1065
John Gilardi: +41 61 324 3018
Thomas Hungerbuehler:  +41 61 324 8425
Isabella Zinck: +41 61 324 7188
Central phone no: +41 61 324 7944
Fax no: +41 61 324 8444
e-mail: investor.relations@novartis.com

North America Office
Richard Jarvis: +1 212 830 2433
Jill Pozarek: +1 212 830 2445
Edwin Valeriano: +1 212 830 2456
Fax no:  +1 212 830 2405
e-mail: investor.relations@novartis.com

Source: Novartis Pharmaceuticals Corporation

Under the terms of the Agreement, Elan will receive from Zogenix an undisclosed upfront payment and future payments upon the achievement of clinical and regulatory milestones for the product. Additionally, Elan will receive royalty payments based on sales of the product upon commercialization. Zogenix will assume responsibility for the clinical development and commercialization of the product in the U.S., and Elan will manufacture the product for Zogenix.

In recent years, U.S. sales of prescription opioids for the treatment of moderate to severe pain have grown dramatically and now exceed $9.1 billion annually. “Opioid analgesics will continue to play a very important role in the effective management of moderate to severe pain for the foreseeable future,” commented Dr.Stephen Farr, President and Chief Operating Officer of Zogenix. “There remains a significant unmet medical need for novel, controlled release opioids that can deliver on the promise of providing consistent, round-the-clock pain relief.”

“This addition means Zogenix now has two drug candidates in late stage development, consistent with our strategy to build a portfolio of products in central nervous system (CNS) indications and pain,” said Roger Hawley, Chief Executive Officer of Zogenix. “We will also have access to Elan’s manufacturing capabilities for this product, which have a proven track record of successfully formulating and manufacturing scheduled drug products that incorporate their proprietary drug delivery technologies. We look forward to advancing this product into Phase 3 development in 2008, and ultimately selling the product via our commercial team. The market potential, therapeutic fit, development timelines, and ability to leverage our commercial capabilities make this a compelling opportunity for Zogenix.”

“This agreement reflects the robustness and flexibility of our drug technology platforms and our commitment to developing improved products that address unmet medical needs,” commented Shane Cooke, Elan’s Chief Financial Officer and head of it’s Drug Technologies business. “We are delighted to be working with Zogenix and look forward to assisting them in their efforts to bring this important product to the market for the benefit of patients.”

About Zogenix, Inc.
Zogenix, Inc., with offices in Emeryville and San Diego, CA, is a private, specialty pharmaceutical company focused on the development and commercialization of medicines to treat neuroscience disorders and pain. The company’s initial focus is the completion of the late-stage development and commercialization of sumatriptan Intraject - a needle-free, single-use, disposable, and easy-to-use subcutaneous delivery system for sumatriptan that will compete in the $2.7 billion triptan segment of the migraine market. The company also plans to license the patented Intraject drug delivery system to other companies. For additional information, visit www.zogenix.com .

About SODAS® Technology  

SODAS (Spheroidal Oral Drug Absorption System) is Elan’s multiparticulate drug delivery system. SODAS Technology continues to be an accepted and approved system by regulatory authorities with approvals for the SODAS based system occurring in the US for Avinza®, Ritalin LA® and Focalin® XR. A number of other compounds are in late stage development utilizing Elan’s SODAS® technology. The SODAS® Technology is part of a suite of capabilities available through Elan Drug Technologies.

SODAS is a registered trademark of Elan Corporation, plc
AVINZA is a registered trademark of King Pharmaceuticals Research and Development, Inc.
FOCALIN and RITALIN LA are registered trademarks of Novartis AG
INTRAJECT is a registered trademark of Zogenix, Inc.

CONTACTS:
Zogenix, Inc.
J.D. Haldeman
VP, Commercial Strategy & Corporate Communications
858-436-8595 or jdhaldeman@zogenix.com

Kureczka/Martin Associates
Joan Kureczka
415-821-2413 or jkureczka@comcast.net

Paliperidone palmitate is a long-acting injectable ester of the active ingredient in INVEGA™1 which utilizes Elan's NanoCrystal® Technology. Upon approval, paliperidone palmitate will be marketed in the U.S. by Janssen, L.P.

Worldwide, it is estimated that one person in every 100 develops schizophrenia, one of the most serious types of mental illness. In the United States, there are currently 2,000,000 people with schizophrenia, with men and women affected equally. The disease is marked by positive symptoms (hallucinations and delusions) and negative symptoms (depression, blunted emotions, and social withdrawal), as well as by disorganized thinking.

Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD), is headquartered in Raritan, NJ (USA), and has nine sites throughout Europe and the United States. J&JPRD employs approximately 3,500 people and is leveraging drug discovery, drug evaluation, and drug development in a variety of therapeutic areas to address unmet medical needs worldwide. The company's major therapeutic areas of focus include hematology, oncology, infectious disease, obesity and metabolic disorders, neurology and psychiatry, pain;and women's health.

Janssen, L.P., based in Titusville, NJ, is a subsidiary of Johnson & Johnson, and is the only pharmaceutical company in the U.S. dedicated solely to mental health. The company currently markets prescription medications for the treatment of schizophrenia, bipolar mania, and irritability associated with autistic disorder. For more information about Janssen, L.P., visit www.janssen.com.

This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from Johnson & Johnson's expectations and projections. Risks and uncertainties include general industry conditions and competition; economic conditions, such as interest rate and currency exchange rate fluctuations; technological advances and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approvals; domestic and foreign health care reforms and governmental laws and regulations; and trends toward health care cost containment. A further list and description of these risks, uncertainties and other factors can be found in Exhibit 99 of the Company's Annual Report on Form 10-K for the fiscal year ended December 31, 2006. Copies of this Form 10-K, as well as subsequent filings, are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. Johnson & Johnson does not undertake to update any forward-looking statements as a result of new information or future events or developments

Important Safety Information For INVEGA™

Elderly Patients with dementia-related psychosis treated with atypical antipsychotic drugs are at an increased risk of death compared to placebo. INVEGA™ (paliperidone) is not approved for the treatment of patients with dementia-related psychosis.

The most common side effects that occurred with INVEGA™ were restlessness and extrapyramidal disorder (for example: involuntary movements, tremors and muscle stiffness).

One risk of INVEGA™ is that it may change your heart rhythm. This effect is potentially serious, and you should talk to your doctor about any current or past heart problems. Some medications interact with INVEGA™. Please inform your health care professional of any medications or supplements that you are taking.

Neuroleptic Malignant Syndrome (NMS) is a rare and potentially fatal side effect reported with INVEGA™ and similar medicines. Call your doctor immediately if the person being treated develops symptoms such as high fever; stiff muscles; shaking; confusion; sweating; changes in pulse, heart rate, or blood pressure; or muscle pain and weakness. Treatment should be stopped if the person being treated has NMS.

Tardive Dyskinesia (TD) is a serious, sometimes permanent side effect reported with INVEGA™ and similar medications. TD includes uncontrollable movements of the face, tongue, and other parts of the body. The risk of developing TD and the chance that it will become permanent is thought to increase with the length of therapy and the overall dose taken by the patient. This condition can develop after a brief period of therapy at low doses, although this is much less common. There is no known treatment for TD, but it may go away partially or completely if therapy is stopped.

INVEGA™ should be used cautiously in people with a seizure disorder, who have had seizures in the past, or who have conditions that increase their risk for seizures.

INVEGA™ and similar medications can raise the blood levels of a hormone known as prolactin, causing a condition known as hyperprolactinemia. Blood levels of prolactin remain elevated with continued use. Some side effects seen with these medications include the absence of a menstrual period; breasts producing milk; the development of breasts by males; and the inability to achieve an erection. The connection between prolactin levels and side effects is unknown.

High blood sugar and diabetes have been reported with INVEGA™ and similar medications. If the person being treated has diabetes or risk factors such as being overweight or a family history of diabetes, blood sugar testing should be performed at the beginning and throughout treatment with INVEGA™. Complications of diabetes can be serious and even life threatening. If signs of high blood sugar or diabetes develop, such as being thirsty all the time, going to the bathroom a lot, or feeling weak or hungry, contact your doctor.

People with narrowing or blockage of the gastrointestinal tract (esophagus, stomach or small or large intestine) should talk to their health care professional before taking INVEGA™.

Some people taking INVEGA™ may feel faint or lightheaded when they stand up or sit up too quickly. By standing up or sitting up slowly and following your health care professional's dosing instructions, this side effect may be reduced or it may go away over time.

Extrapyramidal Symptoms (EPS) are usually persistent movement disorders or muscle disturbances, such as restlessness, tremors, and muscle stiffness. If you observe any of these symptoms, talk to your health care professional.

Inform your health care professional if you are pregnant or if you are planning to get pregnant while taking INVEGA™. Do not breast-feed if you are taking INVEGA™.

INVEGA™ may affect your driving ability; therefore, do not drive or operate machines before talking to your health care professional. Avoid alcohol while on INVEGA™.

INVEGA™ may affect alertness and motor skills; use caution until the effect of INVEGA™ is known.

INVEGA™ may make you more sensitive to heat. You may have trouble cooling off, or be more likely to become dehydrated, so take care when exercising or when doing things that make you warm.

INVEGA™ should be swallowed whole. Tablets should not be chewed, divided, or crushed. Do not be worried if you see something that looks like a tablet in your stool. This is what is left of the tablet after all the medicine has been released.

Janssen, L.P., Web site: www.janssen.com/

Johnson & Johnson Pharmaceutical Research & Development, L.L.C., Web site: www.jnjpharmarnd.com/

NanoCrystal® Technology is a registered trademark of Elan Pharma International Limited, Ireland, a subsidiary of Elan Corporation plc (NYSE:ELN).

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.

“Par is very pleased to have been the first to demonstrate the substantial food effect that exists with the original megestrol acetate oral suspension 800 mg/20 mL. The recognition and understanding of this food effect by health care providers is essential to their successful treatment of cachectic patients,” said Shankar Hariharan, Ph.D., executive vice president and chief scientific officer. “For those AIDS patients with a lack of appetite who may have difficulty eating without the help of medication, Megace ES meets a critical need.” 

In 2005, the U.S. Food and Drug Administration (FDA) approved Megace ES for the treatment of anorexia, cachexia, or an unexplained, significant weight loss in patients with a diagnosis of AIDS. Megace ES can be taken without regard to meals and is dosed at one-fourth the volume of the original product. Megace ES represents the first branded pharmaceutical product developed by Par to be approved for marketing by the FDA. Introduced in July 2005, Megace ES now holds a 20.3 percent share of new prescriptions in the U.S. market for megestrol acetate oral suspension products, according to the IMS Health national prescription audit of retail and mail order trade outlets for the week ending August 25, 2006. 

 “We are pleased to be granted this new patent surrounding our NanoCrystal Technology that recognizes the benefit the reduced food effect provides to cachectic patients. This new patent further strengthens our patent estate protecting our key technology,” commented Paul V. Breen, president and chief operating officer, Elan Pharma International Ltd.

* NanoCrystal® Technology is a registered trademark of Elan Pharma International Limited, Ireland.

Par Discontinues Phase III Clinical Trial
Par today also announced that, due to slow patient enrollment, it has decided to discontinue a Phase III clinical trial of megestrol acetate concentrated suspension in cancer-induced anorexia. Par intends to discuss alternate clinical development options with the FDA. Par is also pursuing the development of new formulations or dosage forms of megestrol acetate concentrated suspension that potentially offer greater patient benefits and that could be available as soon as 2008 or 2009.

Important Information About Megace ES
Megace ES and megestrol acetate oral suspension 800 mg/20mL are contraindicated in patients with a history of hypersensitivity to megestrol acetate or any component of the formulation, or patients with known or suspected pregnancy.
Evidence of adrenal suppression has been observed in patients receiving megestrol acetate oral suspension. The glucocorticoid activity of megestrol acetate oral suspension has not been fully evaluated.

Clinical cases of new onset diabetes mellitus, exacerbation of pre-existing diabetes mellitus, and overt Cushing’s Syndrome have been reported in association with the chronic use of megestrol acetate.

The most common adverse events associated with Megace ES 625 mg/5 mL and megestrol acetate oral suspension 800 mg/20 mL are impotence, flatulence, rash, hypertension, fever, decreased libido, insomnia, dyspepsia, and hyperglycemia.*
Women who participated in studies reported breakthrough bleeding; however, it is unknown if these events are drug- or disease-related. For complete prescribing information, visit www.MegaceES.com.

* Adverse events > placebo derived from the comprehensive adverse events table (=5%) in Megace ES and megestrol acetate oral suspension prescribing information.

About Par Pharmaceutical
Par Pharmaceutical Companies, Inc. develops, manufactures and markets generic drugs and innovative branded pharmaceuticals for specialty markets. In 2005, Par received approval for and introduced the appetite stimulant Megace ES, its first branded pharmaceutical product. Par’s Generic Products Division is committed to providing high-quality pharmaceuticals that are affordable and accessible to patients. Par manufactures, markets or licenses more than 110 generic drugs. For press release and other company information, visit www.parpharm.com. 

About NanoCrystal® Technology and Elan Drug Technologies
Elan's NanoCrystal technology is a proven, robust, drug optimization technology enabling solubility easily and effectively for many poorly water-soluble compounds. The technology which can offer enhanced commercialization opportunities is covered by 1,077 U.S. and foreign patents and patent applications 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.

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.

Certain statements in this press release constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. To the extent any statements made in this news release contain information that is not historical, these statements are essentially forward-looking and are subject to risks and uncertainties, including the difficulty of predicting FDA filings and approvals, acceptance and demand for new pharmaceutical products, the impact of competitive products and pricing, new product development and launch, reliance on key strategic alliances, uncertainty of patent litigation filed against us, availability of raw materials, the regulatory environment, fluctuations in operating results and other risks and uncertainties detailed from time to time in the Company's filings with the Securities and Exchange Commission, such as the Company’s Form 10-K, Form 10-Q, and Form 8-K reports.

Press Release Source: Par Pharmaceutical Companies, Inc
 

Contact:
Stephem Mock +1-201-802-4000, smock@parpharm.com