|
| |
Biogen Idec and Acorda Therapeutics Announce Collaboration Agreement to
Develop and Commercialize MS Therapy Fampridine-SR in Markets Outside the U.S.
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... (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
| |
|
