BGEN & Elan collaborate on antegren. What are the terms of this collaboration?
Title: Elan and Biogen Announce Positive Phase II Results for Antegren(R)
(Natalizumab) in Multiple Sclerosis and Crohn's Disease
Date: 1/22/01
CAMBRIDGE, Mass., and DUBLIN, Ireland, Jan. 22 /PRNewswire/ --
Biogen, Inc. (Nasdaq: BGEN) and Elan Corporation, plc (NYSE: ELN)
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.
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."
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."
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. |
