CAMBRIDGE, Mass., SAN DIEGO, Calif., and DUBLIN, Ireland, Aug. 17
/PRNewswire-FirstCall/ -- Biogen Idec (Nasdaq: BIIB) and Elan Corporation, plc
(NYSE: ELN) announced today that the companies have submitted an application
for approval of ANTEGREN(R) (natalizumab) as a treatment for multiple
sclerosis (MS) in Canada and expect to submit applications in Australia and
Switzerland, based on one-year data from the ongoing Phase III trials. The
companies also anticipate that the first release of the one-year data from
these trials will be upon approval of natalizumab by the U.S. Food and Drug
Administration (FDA).
(Logo: http://www.newscom.com/cgi-bin/prnh/20031112/LAW121LOGO )
The companies have submitted their application to regulatory authorities
in Canada and anticipate submissions will be filed in Australia and
Switzerland in the second half of 2004. The companies previously announced
that the FDA designated natalizumab for Priority Review and Accelerated
Approval, and that the European Medicines Agency validated their application.
Based on the FDA's designation of Priority Review for natalizumab in MS, the
companies anticipate action by the FDA approximately six months from the
submission date, rather than 10 months for a standard review. On May 25,
2004, the companies announced they had previously submitted the Biologics
License Application for the approval of natalizumab for MS.
The decision to file applications for approval in Canada, Australia and
Switzerland was made after discussions with the countries' respective
regulatory agencies of the one-year data from the two ongoing two-year Phase
III trials in MS. The companies are committed to completing the two-year
trials. After discussion with the regulatory authorities and clinical
investigators, the companies expect to release the one-year data upon U.S.
approval, in order to protect the integrity of the two-year trials. The
companies anticipate that the two-year data will be available beginning in the
first half of 2005.
The regulatory review of natalizumab will be based on one-year data from
two ongoing Phase III trials, AFFIRM (natalizumab safety and efficacy in
relapsing-remitting MS) and SENTINEL (safety and efficacy of natalizumab in
combination with AVONEX(R) (Interferon beta-1a)), which evaluate the ability
of natalizumab to slow the progression of disability and reduce the rate of
clinical relapses in patients with relapsing-remitting MS.
About ANTEGREN (natalizumab)
Natalizumab, a humanized monoclonal antibody, is the first alpha-4
antagonist in the new selective adhesion molecule (SAM) inhibitor class. It
is designed to inhibit the migration of immune cells into tissues where they
may cause or maintain inflammation. To date, approximately 2,800 patients
have received natalizumab in clinical trials, and the safety profile continues
to support further development. In placebo-controlled trials to date, in both
Crohn's disease (CD) and MS, the most commonly reported adverse events in
either group were headache, fatigue and nasopharyngitis.
Biogen Idec and Elan are collaborating equally on the development of
natalizumab in MS, CD, and rheumatoid arthritis (RA).
About Biogen Idec
Biogen Idec (Nasdaq: BIIB) creates new standards of care in oncology and
immunology. As a global leader in the development, manufacturing, and
commercialization of novel therapies, Biogen Idec transforms scientific
discoveries into advances in human healthcare. For product labeling, press
releases and additional information about the company, please visit
http://www.biogenidec.com.
About Elan
Elan Corporation, plc (NYSE: ELN) is a neuroscience-based biotechnology
company that is focused on discovering, developing, manufacturing and
marketing advanced therapies in neurodegenerative diseases, autoimmune
diseases, and severe pain. Elan shares trade on the New York, London and
Dublin Stock Exchanges. For additional information about the company, please
visit http://www.elan.com.
Safe Harbor/Forward Looking Statements
This press release contains forward-looking statements regarding the
approval process for ANTEGREN(R) (natalizumab) and the release of data related
to Phase III trials of natalizumab in MS. These statements are based on the
companies' current beliefs and expectations. Drug development involves a high
degree of risk. Factors which could cause actual results to differ materially
from the companies' current expectations include: the risk that unexpected
concerns may arise from additional data or analysis, that regulatory
authorities may require additional information, further studies, or may fail
to approve natalizumab, or that the companies may encounter other unexpected
hurdles. For more detailed information on the risks and uncertainties
associated with the companies' drug development and other activities, see the
periodic and other reports of Biogen Idec Inc. and Elan Corporation, plc filed
with the Securities and Exchange Commission. The companies assume no
obligation to update any forward-looking statements, whether as a result of
new information, future events or otherwise.
For More Information Contact:
MEDIA CONTACTS:
Biogen Idec
Amy Brockelman
Ph: 617 914 6524
Elan
Anita Kawatra
Ph: 212 407 5755
800 252 3526
INVESTOR CONTACTS:
Biogen Idec
Elizabeth Woo
Ph: 617 679 2812
Elan
Emer Reynolds
Ph: 353 1 709 4000
800 252 3526
SOURCE Biogen Idec
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Related links:
http://www.biogenidec.com
http://www.elan.com
Company News On-Call:
http://www.prnewswire.com/comp/101550.html
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AP Archive: http://photoarchive.ap.org
PRN Photo Desk, 888-776-6555 or 212-782-2840
CONTACT:
MEDIA CONTACTS, Amy Brockelman of Biogen
Idec, +1-617-914-6524; or Anita Kawatra of Elan, +1-212-407-5755,
or +1-800-252-3526; or INVESTOR CONTACTS, Elizabeth Woo of Biogen
Idec, +1-617-679-2812; or Emer Reynolds of Elan, 353 1 709 4000,
or +1-800-252-3526
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