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| Elan and Biogen Announce Positive Phase II Results For Antegren(R) (Natalizumab) in Multiple Sclerosis and Crohn's Disease |
- Companies to Move to Phase III Trials -
DUBLIN, Ireland and CAMBRIDGE, Mass., Jan. 22 /PRNewswire/ --
Elan Corporation, plc (NYSE: ELN) and Biogen, Inc. (Nasdaq: BGEN) announced
today positive results from preliminary analyses of two large Phase II
clinical studies with Antegren(R) (natalizumab) in multiple sclerosis (MS) and
Crohn's Disease. The companies are now proceeding to initiate Phase III
clinical studies in 2001 in both these diseases.
The first of the studies conducted was a Phase II double-blind placebo
controlled trial which included 213 MS patients at 26 sites in the U.S.,
Canada and the U.K. Patients received monthly doses of Antegren or placebo
over a six-month period. The primary endpoint of a reduction in new
gadolinium enhancing lesions compared to placebo over the 6-month treatment
period was achieved with a high degree of statistical significance.
A separate Phase II double-blind placebo controlled study conducted across
38 sites in 8 European countries included 240 patients with moderate to severe
Crohn's Disease. Patients received doses of Antegren or placebo at week 0 and
week 4. This study also demonstrated statistically significant positive
results on multiple endpoints, including induction of remission as measured by
the Crohn's Disease Activity Index.
Further information about the potential safety and efficacy of the drug
will be presented at a scientific conference later this year. The companies
will be conferring with regulatory authorities about next steps in the drug's
development. Antegren has now been evaluated in approximately 600 patients in
10 clinical studies.
Donal J. Geaney, Elan's chairman and chief executive officer, said, "We
are delighted that these positive results support the continued and
accelerated development of Antegren as a potentially important new therapy for
the treatment of MS and Crohn's disease. In conjunction with Biogen, we look
forward to advancing Antegren into Phase III studies."
James C. Mullen, Biogen's president and chief executive officer, said, "As
a biotechnology company committed to developing breakthrough therapies for
people with serious diseases, we are very excited about these results. With
approximately one million MS patients worldwide, we believe that Antegren,
used alone or in combination with Avonex(R) (Interferon beta-1a), should allow
us to offer more solutions to a broader range of MS patients than are
currently available. For the 300,000 patients with moderate-severe Crohn's
Disease, Antegren offers a potential novel treatment approach for this patient
population."
In August 2000, Biogen and Elan announced a worldwide, exclusive
collaboration to develop, manufacture, and commercialize Antegren. Antegren,
which was discovered by Elan, is a humanized monoclonal antibody and the first
in a new class of potential therapeutics known as alpha 4 integrin inhibitors
that are designed to block immune cell adhesion to blood vessel walls and
subsequent migration of lymphocytes into tissue. Antegren binds to the cell
surface receptors known as alpha-4-beta-1 (VLA-4) and alpha-4-beta-7.
Antegren may be useful in the treatment of a range of inflammatory and
non-inflammatory diseases. Both Elan and Biogen are pioneers in the study of
this pathway.
Elan Corporation, plc is a leading worldwide fully integrated
pharmaceutical company headquartered in Ireland, with its principal research,
development, manufacturing and marketing facilities located in Ireland, the
United States and Israel. Elan is focused on the discovery, development and
marketing of therapeutic products and services in neurology, pain management,
oncology, infectious disease and dermatology and on the development and
commercialization of products using its extensive range of proprietary drug
delivery technologies. Elan shares trade on the New York, London and Dublin
Stock Exchanges.
Biogen, Inc., winner of the U.S. National Medal of Technology, is a
biopharmaceutical company principally engaged in discovering and developing
drugs for human healthcare through genetic engineering. Headquartered in
Cambridge, MA, the Company's revenues are generated from international sales
of AVONEX(R) (Interferon beta-1a) for treatment of relapsing forms of multiple
sclerosis, and from the worldwide sales by licensees of a number of products,
including alpha interferon and hepatitis B vaccines and diagnostic products.
Biogen's research and development activities are focused on novel products to
treat inflammatory and autoimmune diseases, neurological diseases, cancer,
fibrosis and congestive heart failure. The Company maintains active clinical
research programs in protein therapeutics, small molecules, genomics and gene
therapy. For copies of press releases and additional information about the
Company, please consult Biogen's Homepage on the World Wide Web at
http://www.biogen.com.
In addition to historical information, this press release contains
forward-looking statements within the meaning of the "safe harbor" provisions
of the Private Securities Litigation Reform Act of 1995. Reference is made in
particular to statements regarding the potential for Antegren as a therapeutic
product. These statements are based on the companies' current beliefs and
expectations as to such future outcomes. Drug development involves a high
degree of risk. Success in early stage clinical trials does not ensure that
later stage or larger scale clinical trials will be successful. Factors which
could cause actual results to differ materially from the companies' current
expectations include the risk that the product may not show therapeutic effect
or an acceptable safety profile in subsequent trials or may not meet
applicable regulatory standards, or that problems or delays may arise during
clinical trials or in the course of the development, testing or manufacturing
of the product as well as the other risks and uncertainties described from
time to time in the companies' periodic reports filed with the Securities and
Exchange Commission.
SOURCE Elan Corporation, plc and Biogen, Inc.
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CONTACT:
Investors, U.S. - Jack Howarth, or Media -
Max Gershenoff, 212-407-5740, 800-252-3526; Investors, Europe -
Emer Reynolds, 353-1-709-4000 or 00800-28352600, all of Elan
Corporation, plc; or Investors - Elizabeth Woo, 617-679-2822 or
Kathryn Bloom, 617-679-2851, both of Biogen, Inc.
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