This placebo-controlled, randomized trial of patients with relapsingmultiple sclerosis demonstrated benefits of natalizumab (an4 integrin antagonist) in all the primary and secondary outcomemeasures. After two years, the probability of sustained progressionof disability was 17 percent with natalizumab and 29 percentwith placebo. Fatigue and allergic reaction were more commonamong patients receiving natalizumab.
In this randomized trial involving patients with relapsing multiplesclerosis who had had relapses despite treatment with interferon,natalizumab in combination with interferon was more effectivethan interferon alone. After two years, the probability of sustaineddisability progression was 23 percent with combination treatmentand 29 percent with interferon alone. Progressive multifocalleukoencephalopathy developed in two patients receiving combinationtreatment, and one of these two patients died of this seriouscomplication of therapy.
Progressive multifocal leukoencephalopathy (PML) has been reportedin three patients who were treated with natalizumab. In thissystematic evaluation for PML in patients who received natalizumabin clinical trials, no additional cases were identified. Theauthors estimated the risk of PML in the population studiedto be about 1 in 1000 patients treated for 18 months. The riskof PML after longer treatment with natalizumab is not known.
2/16/05
WSJ MS
Drug Tysabri
Is Cleared
for Use In
Clinical
Trials
By WILLIAM
M. BULKELEY
"Biogen said
yesterday
that it
expects a
"major
approval" of
Tysabri for
multiple
sclerosis
this year.
Elan has
said
previously
that it
expects to
be allowed
to resume
U.S.
marketing
this year.
2/16/05
Keeping
Faith In His
Best Buys
(240 sec.)
Marketocracy's
Ken Kam
still loves
energy,
e-commerce,
and a
resurgent
biotech.
June 5, 2006 UW
testing
new
medicines
in
Alzheimer's
fight
By
Warren
King
Seattle
Times
medical
reporter
No side
Effects
from
AAB-001
(note
that
Elan has
50% dibs
on the
Lilly
drug
mentioned)
Feb. 17, 2006 Lars Eckman on
Irish Radio
:
Vaccine
for
Alzheimer's
Disease
The goal is
to eliminate
Beta Amyloid
in the
brain, which
is the toxic
species that
gives the
symptoms of
the disease.
The antibody
attacks the
A-Beta 42.
It extracts
these
peptides out
of the
plaques. The
plaque
disappears
and we can
hopefully
then give
the memory
back to the
patients.
Question:
So, in
effect you
are
administrating
an
artificial
harmless
form of this
Beta Amyloid
into peoples
bodies and
hoping they
will produce
antibodies
in response
to it.
Answer: That
is correct,
that is the
harmless
species of A
Beta. The
form that
you
described
have
actually
already been
tested in
man. We did
two studies,
one with 120
and one with
360
patients.
That study
revealed on
the positive
side we
could
improve
memory
function, we
could
improve
executive
functions
and we could
improve the
quality of
life of the
patients.
However that
drug had
side effects
in some, in
a few
patients, a
transient
inflammation.
So, we at
that point
decided to
abandon the
program. We
identified
what the
problem was
and we are
now back
into
clinical
programs
with a
product that
do not give
raise to
these kind
of problems
Dec.
2003
Folding
proteins in fatal ways
Dennis J. Selkoe (e-mail: dselkoe@rics.bwh.harvard.edu)
Center for Neurologic Diseases, Harvard Medical School,
Brigham and Women’s Hospital, Boston, Massachusetts
02115, USA
Tripos Discovery Research (TDR)
will assist Elan Pharmaceuticals in analyzing and enhancing the
diversity of its small molecule screening collection.
TDR will perform computational clustering of key subsets and
determine optimal areas for expansion. The company also will
provide high-throughput quality control analyses of legacy
compounds via mass spectrometry.
Applying its computational design and therapeutic medicinal
chemistry tools, TDR says that it is able to reduce drug
discovery timelines by up to 30%.
2/9/06
Elan to Sell
Rights to
Prialt in
Europe to
Eisai
related...
Analysts
said the
terms of the
deal were
good
for
Dublin-based
Elan, which
launched
Prialt in
the United
States and
Europe a
year ago.
They noted
that U.S.
sales of
Prialt in
2005 totaled
just US$6.3
million
(euro7.6
million),
whereas
Thursday's
deal with
Tokyo-based
Eisai would
allow Elan
to receive
US$50
million in
cash up
front and
the
possibility
of receiving
up to US$50
million more
if European
sales of
Prialt reach
a series of
targets.
Priced on 1/20/05.
Actual AWP (average wholesale price)
from a local drug wholesaler.
NOTE: Pharmacies can buy
at AWP - 20% or better depending
on buying power. This product is being
distributed via
normal wholesale ordering routes (unlike
Tysabri which is,
at this point, distributed via just a
few selected
wholesalers) and any pharmacy should be
able to have this
product delivered directly to them.
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4 integrin antagonist) in all the primary and secondary outcome measures. After two years, the probability of sustained progression of disability was 17 percent with natalizumab and 29 percent with placebo. Fatigue and allergic reaction were more common among patients receiving natalizumab. 
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