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This excerpt taken from the ELN 20-F filed Feb 26, 2009. Tysabri
for the Treatment of Multiple Sclerosis
In June 2006, the FDA approved the reintroduction of Tysabri
as a monotherapy to treat relapsing forms of MS. Approval
for the marketing of Tysabri in the European Union was
also received in June 2006. The distribution of Tysabri
in both the United States and European Union commenced in
July 2006.
In the United States, Europe and the ROW, provisions are in
place to ensure patients are informed of the risks associated
with Tysabri therapy, including PML, and to enhance
collection of post-marketing data on the safety and utilization
of Tysabri for MS. PML is an opportunistic viral
infection of the brain that can lead to death or severe
disability.
For 2008, Tysabri global in-market net sales increased by
137% to $813.0 million from $342.9 million for 2007.
Our recorded sales of Tysabri for 2008 increased 140% to
$557.1 million, over the $231.7 million for 2007.
The significant growth in Tysabri sales reflects strong
patient demand across global markets. Tysabri is
currently approved in more than 40 countries, including the
United States, the European Union, Switzerland, Canada,
Australia and New Zealand.
Tysabri is a treatment approved for relapsing forms of
multiple sclerosis (MS) in the United States and
relapsing-remitting MS in the European Union. According to data
that have been published in the New England Journal of
Medicine, after two years, Tysabri treatment led to a
68% relative reduction in the annualized relapse rate, compared
to placebo, and reduced the relative risk of disability
progression by 42% to 54%.
Elan and Biogen Idec presented additional Tysabri data at
the World Congress on Treatment and Research in MS in Montreal
on September 19, 2008, including a post-hoc analysis of
data from the Tysabri MS clinical trials. This analysis
provided the first evidence that Tysabri is associated
with a significant improvement in functional outcome, rather
than only slowing or preventing progression of disability, in
those living with relapsing MS.
As of the end of December 2008, approximately
37,600 patients were on therapy worldwide, including
approximately 20,200 commercial patients in the United States
and approximately 16,900 commercial patients in the ROW.
Cumulatively, in the post-marketing setting approximately
48,300 patients have been treated with Tysabri as of
the end of December 2008. Of those patients, approximately
20,000 have received at least one year of Tysabri
therapy, approximately 10,700 patients have received at
least 18 months of Tysabri therapy, and
4,300 patients have received at least 24 months of
Tysabri therapy. In the post-marketing setting, five
cases of PML have occurred in Tysabri-treated MS patients.
The safety data to date continues to support a favorable
benefit-risk profile for Tysabri. Complete information
about Tysabri for the treatment of MS, including
important safety information, is available at
http://www.tysabri.com.
The contents of this website are not incorporated by reference
into this Form 20-F.
Table of Contents
This excerpt taken from the ELN 20-F filed Feb 28, 2008. Tysabri
for the Treatment of Multiple Sclerosis
In June 2006, the FDA approved the reintroduction of Tysabri
as a monotherapy to treat relapsing forms of MS. Approval
for the marketing of Tysabri in the European Union was
also received in June 2006. The distribution of Tysabri
in both the United States and European Union commenced in
July 2006. Tysabri currently is approved in
Table of Contents
more than 30 countries worldwide, including the United States,
the countries of the European Union, Switzerland, Canada,
Australia, New Zealand and Israel.
In the United States, Europe and the ROW, provisions are in
place to ensure patients are informed of the risks associated
with Tysabri therapy, including PML, and to enhance
collection of post-marketing data on the safety and utilization
of Tysabri for MS. PML is an opportunistic viral
infection of the brain that usually leads to death or severe
disability. Three cases of PML were detected in clinical trials
with Tysabri among patients who were also taking other
therapies, leading to a temporary marketing suspension of the
product in the United States in February 2005.
As of late December 2007, there were approximately
21,100 patients receiving Tysabri in either clinical
or commercial settings, with 12,900 patients on Tysabri
in the U.S. commercial setting, 7,500 on Tysabri
outside of the United States in the commercial setting, and
700 patients in global clinical trials. The safety data to
date continue to support a favorable benefit-risk profile for
Tysabri. There have been no new reports of confirmed
cases of PML since the U.S. reintroduction and EU launch in July
2006. Global in-market net sales of Tysabri totaled
$342.9 million for 2007 (2006: $38.1 million), with
global net revenue reported by Elan of $231.7 million for
2007 (2006: $17.5 million).
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