|
|
 | | | |
- close
- close
- close
- close
| |||||||||
This excerpt taken from the ELN 6-K filed Jan 14, 2008.
Prescribing
Program
The
TOUCH™ (TYSABRI Outreach: Unified Commitment to Health) Prescribing
Program was developed in conjunction with the FDA to facilitate appropriate
use
of TYSABRI and to assess, on an ongoing basis, the incidence and risk factors
for PML and other serious opportunistic infections associated with TYSABRI
treatment. This program represents Elan and Biogen Idec’s commitment
to making the unique benefits of TYSABRI available in a responsible
manner. The program already has been implemented for patients
receiving TYSABRI therapy for MS.
About
Crohn’s Disease
An
estimated 500,000 people in the United States have Crohn's disease, a chronic
and progressive inflammatory disease of the gastrointestinal tract, which
commonly affects both men and women.
The
disease usually causes diarrhea and crampy abdominal pain, often associated
with
fever, and at times rectal bleeding. Loss of appetite and weight loss also
may
occur. Complications include narrowing of the intestine, obstruction, abscesses,
and fistulas (abnormal channels connecting the intestine and other organs,
including the skin), and malnutrition. Most patients eventually require surgery,
which has both risks and potential short- and long-term
complications.
Crohn’s
disease can have a devastating impact on the lifestyle of patients, many of
whom
are young and active. Currently there is no medical or surgical cure
for Crohn’s disease. Many patients fail to respond to current therapies,
including biological therapies such as agents that inhibit tumor necrosis factor
alpha (TNF-alpha). Due to this failure of current therapies in CD,
therapies that have alternate biological targets provide patients and physicians
with therapeutic options.
About
TYSABRI
Data
from
the ENCORE trial showed that TYSABRI induced response and remission among
patients with moderately to severely active Crohn’s disease, and objective
evidence of inflammation, as measured by elevated C-reactive
protein. After 12 weeks of therapy, 60% of TYSABRI-treated patients
attained response, compared to 44% of placebo treated patients, and 48% of
patients had sustained response at both weeks 8 and 12, compared to 32% of
placebo 2
treated
patients (p<0.005 for both). Among the patients who had inadequate
response to prior treatment with inhibitors of TNF-alpha, 38% achieved sustained
response at weeks 8 and 12.
Data
from the ENACT-2 showed that an
additional year of TYSABRI therapy sustained response and remission among
patients with an initial response to TYSABRI after 3 months in
ENACT-1. Of patients with response in ENACT-1, sustained response
during ENACT-2 was seen in 61% of patients treated with TYSABRI at every visit
through an additional 6 months of therapy, compared to 29% for
placebo. This treatment difference was also sustained through 12
months of additional therapy (54% vs. 20%). Remission was sustained
at every visit with an additional 6 months or 12 months of TYSABRI in 45% and
40% of patients, respectively, compared to 26% and 15% of placebo treated
patients (p<0.005 for all comparisons). Among the patients that
had previously failed TNF-inhibitors, response and remission was sustained
at
every visit through an additional 6 months of TYSABRI in 52% and 30% of
patients, respectively. Among patientson steroids and in whom
a clinical
response was achieved, approximately two-thirds were able to discontinue
steroids within 10 weeks of beginning to taper steroids.
TYSABRI
increases the risk of progressive multifocal leukoencephalopathy (PML), an
opportunistic viral infection of the brain that usually leads to death or severe
disability. Other serious adverse events that have occurred in TYSABRI-treated
patients included hypersensitivity reactions (e.g., anaphylaxis) and infections.
Serious opportunistic and other atypical infections have been observed in
TYSABRI-treated patients, some of whom were receiving concurrent
immunosuppressants. Herpes infections were slightly more common in patients
treated with TYSABRI. In MS and CD clinical trials, the incidence and rate
of
other serious adverse events, including serious infections, were similar in
patients receiving TYSABRI and those receiving placebo. Common adverse events
reported in TYSABRI-treated MS patients include headache, fatigue, infusion
reactions, urinary tract infections, joint and limb pain, and
rash. Other common adverse events reported in TYSABRI-treated CD
patients include respiratory tract infections and nausea. Clinically
significant liver injury has been reported in patients treated with TYSABRI
in
the post-marketing setting.
TYSABRI
has previously been approved for relapsing forms of 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 (p<0.001) in the annualized relapse rate compared to
placebo and reduced the relative risk of disability progression by 42-54%
(p<0.001). In addition to the United States and European Union,
TYSABRI is also approved for MS in Switzerland, Canada, Australia, New Zealand
and Israel. TYSABRI was discovered by Elan and is co-developed with Biogen
Idec.
For
more
information about TYSABRI please visit www.tysabri.com, www.biogenidec.com
or
www.elan.com, or call 1-800-456-2255.
About
Elan
Elan
Corporation, plc is a neuroscience-based biotechnology company committed to
making a difference in the lives of patients and their families by dedicating
itself to bringing innovations in science to fill significant unmet medical
needs that continue to exist around the world. Elan shares trade on
the New York, London and Dublin Stock Exchanges. For additional
information about the company, please visit www.elan.com. 3
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.
Safe
Harbor/Forward-Looking
Statements
This
press release contains
forward-looking statements regarding TYSABRI. These statements are based on
the
companies’ current beliefs and expectations. The commercial potential
of TYSABRI is subject to a number of risks and uncertainties. Factors
which could cause actual results to differ materially from the companies’
current expectations include the risk that we may be unable to adequately
address concerns or questions raised by FDA or other regulatory authorities,
that concerns may arise from additional data, that the incidence and/or risk
of
PML or other opportunistic infections in patients treated with TYSABRI may
be
higher than observed in clinical trials, or that the companies may encounter
other unexpected hurdles. Drug development and commercialization
involves a high degree of risk.
For
more detailed information on the
risks and uncertainties associated with the companies’ drug development and
other activities, see the periodic and current reports that Biogen Idec and
Elan
have 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.
Source: Elan
Corporation, plc
and Biogen Idec
###
4
|