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ELN » Topics » The failure to reintroduce Tysabri to the market, or a substantial delay in such reintroduction, would have a material adverse effect on us.This excerpt taken from the ELN 6-K filed Mar 31, 2006. The failure to reintroduce Tysabri
to the market, or a substantial delay in such reintroduction,
would have a material adverse effect on us.
In February 2005, Elan and Biogen Idec voluntarily suspended the
marketing and clinical dosing of Tysabri. This decision
was based on reports of two serious adverse events, one of which
was fatal, in patients treated with Tysabri in
combination with Biogen Idec’s product Avonex in clinical
trials. These events involved two cases of PML, a rare and
potentially fatal, demyelinating disease of the central nervous
system. In March 2005, the companies announced that a patient
who had received eight infusions of Tysabri in a CD trial
had died of PML in December 2003. The case had originally been
reported by a clinical trial investigator as malignant
astrocytoma.
Elan and Biogen Idec completed a comprehensive safety evaluation
in October 2005 of more than 3,000 Tysabri patients in
collaboration with clinical trial investigators and leading
experts in PML and neurology. The results of the safety
evaluation identified no new confirmed cases of PML beyond the
three previously reported.
In September 2005, Elan and Biogen Idec submitted to the FDA an
sBLA for Tysabri which the FDA subsequently designated
for Priority Review.
On 7-8 March 2006, the PCNS Advisory Committee reviewed and
voted unanimously to recommend that Tysabri be
reintroduced as a treatment for relapsing forms of MS. On 21
March 2006, we and Biogen Idec were informed by the FDA that the
agency would extend its regulatory review of Tysabri by
up to 90 days in order to complete a full review of the
Tysabri risk management plan. Under the revised timeline,
we anticipate an action from the FDA about the reintroduction of
Tysabri as a treatment for relapsing forms of MS on or
before 28 June 2006.
If it is determined that PML is caused by Tysabri, if
there are more such serious adverse events in patients treated
with Tysabri or if we cannot obtain sufficient
information to understand the risks associated with
Tysabri, then we would be seriously and adversely
affected. Further, if we cannot resume marketing Tysabri,
or if we face a substantial delay in the resumption of marketing
Tysabri, then we will be materially and adversely
affected.
This excerpt taken from the ELN 20-F filed Mar 30, 2006. The
failure to reintroduce Tysabri to the market, or a substantial
delay in such reintroduction, would have a material adverse
effect on us.
In February 2005, Elan and Biogen Idec, Inc. (Biogen Idec)
voluntarily suspended the marketing and clinical dosing of
Tysabri. This decision was based on reports of two
serious adverse events, one of which was fatal, in patients
treated with Tysabri in combination with Biogen
Idec’s product
Avonex®
(Interferon beta-1A) in clinical trials. These events involved
two cases of progressive multifocal leukoencephalopathy (PML), a
rare and potentially fatal, demyelinating disease of the central
nervous system. In March 2005, the companies announced that a
patient who had received eight infusions of Tysabri in a
Crohn’s disease trial had died of PML in December 2003. The
case had originally been reported by a clinical trial
investigator as malignant astrocytoma.
Elan and Biogen Idec completed a comprehensive safety evaluation
in October 2005 of more than 3,000 Tysabri patients in
collaboration with clinical trial investigators and leading
experts in PML and neurology. The results of the safety
evaluation identified no new confirmed cases of PML beyond the
three previously reported.
In September 2005, Elan and Biogen Idec submitted to the
U.S. Food and Drug Administration (FDA) a supplemental
Biologics License Application (sBLA) for Tysabri, which
the FDA subsequently designated for Priority Review. On March
7-8, 2006, the Peripheral and Central Nervous System (PCNS)
Drugs Advisory Committee of the FDA reviewed and voted
unanimously to recommend that Tysabri be reintroduced as
a treatment for relapsing forms of multiple sclerosis (MS). On
March 21, 2006, we and Biogen Idec were informed by the FDA
that the agency would extend its regulatory review of
Tysabri by up to 90 days in order to complete a full
review of the Tysabri risk management plan. Under the
revised timeline, we anticipate an action from the FDA about the
reintroduction of Tysabri as a treatment for relapsing
forms of MS on or before June 28, 2006.
If it is determined that PML is caused by Tysabri, if
there are more such serious adverse events in patients treated
with Tysabri or if we cannot obtain sufficient
information to understand the risks associated with
Tysabri, then we would be seriously and adversely
affected. Further, if we cannot resume marketing Tysabri,
or if we face a substantial delay in the resumption of marketing
Tysabri, then we will be materially and adversely
affected.
This excerpt taken from the ELN 6-K filed Apr 11, 2005. The failure to reintroduce Tysabri to the market, or a substantial delay in such reintroduction, would have a material adverse effect on us. On 28 February 2005, we and Biogen Idec voluntarily suspended the marketing and clinical dosing of Tysabri. This decision was based on reports of two serious adverse events in patients treated with Tysabri in combination with Biogen Idec’s product Avonex in clinical trials. These events involved two cases of PML, a rare and frequently fatal demyelinating disease of the central nervous system. On 30 March 2005, we and Biogen Idec announced that a patient who had received eight infusions of Tysabri in a Crohn’s trial had died of PML in December 2003. If it is determined that these serious adverse events were caused by Tysabri, if there are more such serious adverse events in patients treated with Tysabri or if we cannot obtain sufficient information to understand the risks associated with Tysabri, then we would be seriously and adversely affected. Further, if we cannot resume marketing and clinical dosing of Tysabri, or if we face a substantial delay in the resumption of marketing Tysabri, then we will be materially and adversely affected. | EXCERPTS ON THIS PAGE:
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