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This excerpt taken from the ELN 20-F filed Feb 26, 2009. Development
and Marketing Collaboration Agreement with Biogen
Idec
In August 2000, we entered into a development and marketing
collaboration agreement with Biogen Idec, successor to Biogen,
Inc., to collaborate in the development and commercialization of
Tysabri for MS and CD, with Biogen Idec acting as the
lead party for MS and Elan acting as the lead party for CD.
In November 2004, Tysabri received regulatory approval in
the United States for the treatment of relapsing forms of MS. In
February 2005, Elan and Biogen Idec voluntarily suspended the
commercialization and dosing in clinical trials 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 Avonex in clinical trials.
These events involved two cases of PML, a rare and potentially
fatal, demyelinating disease of the central nervous system. Both
patients received more than two years of Tysabri therapy
in combination with Avonex. In March 2005, the companies
announced that their ongoing safety evaluation of Tysabri
led to a previously diagnosed case of malignant astrocytoma
being reassessed as PML, in a patient in an open label CD
clinical trial. The patient had received eight doses of
Tysabri over an
18-month
period. The patient died in December 2003.
A comprehensive safety evaluation was performed of more than
3,000 Tysabri patients in collaboration with leading
experts in PML and neurology. The results of the safety
evaluation performed in 2005 yielded no new confirmed cases of
PML beyond the three previously reported.
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In September 2005, Elan and Biogen Idec submitted to the FDA a
sBLA for Tysabri, which the FDA subsequently designated
for Priority Review. On March 7-8, 2006, the Peripheral Central
Nervous System Drug Advisory Committee reviewed and voted
unanimously to recommend that Tysabri be reintroduced as
a treatment for relapsing forms of MS.
In June 2006, the FDA approved the reintroduction of Tysabri
for the treatment of relapsing forms of MS. Approval for the
marketing of Tysabri in the European Union was also
received in June 2006 and has subsequently been received in a
number of other countries. The distribution of Tysabri in
both the United States and the ROW commenced in July 2006.
Global in-market net sales of Tysabri in 2008 were
$813.0 million (2007: $342.9 million; 2006:
$38.1 million), consisting of $421.6 million (2007:
$217.4 million; 2006: $28.2 million) in the United
States and $391.4 million (2007: $125.5 million; 2006:
$9.9 million) in the ROW.
On January 14, 2008, the FDA approved the sBLA for
Tysabri, for the treatment of patients with CD, and
Tysabri was launched in this indication at the end of the
first quarter of 2008. On December 12, 2008, we announced a
realignment of our commercial activities in Tysabri for
CD, shifting our efforts from a traditional sales model to a
model based on clinical support and education.
Tysabri was developed and is now being marketed in
collaboration with Biogen Idec. In general, subject to certain
limitations imposed by the parties, we share with Biogen Idec
most development and commercialization costs. Biogen Idec is
responsible for manufacturing the product. In the United States,
we purchase Tysabri from Biogen Idec and are responsible
for distribution. Consequently, we record as revenue the net
sales of Tysabri in the U.S. market. We purchase
product from Biogen Idec as required at a price, which includes
the cost of manufacturing, plus Biogen Idec’s gross profit
on Tysabri and this cost, together with royalties payable
to other third parties, is included in cost of sales.
In the ROW market, Biogen Idec is responsible for distribution
and we record as revenue our share of the profit or loss on ROW
sales of Tysabri, plus our directly incurred expenses on
these sales. In 2008, we recorded revenue of $135.5 million
(2007: $14.3 million; 2006: negative $10.7 million).
As a result of the strong growth in Tysabri sales, in
July 2008, we made an optional payment of $75.0 million to
Biogen Idec in order to maintain our approximate 50% share of
Tysabri for annual global in-market net sales of
Tysabri that are in excess of $700.0 million. In
addition, we exercised our option to pay a further
$50.0 million milestone to Biogen Idec in order to maintain
our percentage share of Tysabri at approximately 50% for
annual global in-market net sales of Tysabri that are in
excess of $1.1 billion. This $50.0 million payment was
made in January 2009 and was included in intangible assets and
accrued other liabilities on our Consolidated Balance Sheet at
December 31, 2008. The intangible assets have been and will
be amortized on a straight-line basis over approximately
11 years.
This excerpt taken from the ELN 20-F filed Feb 28, 2008. Development
and Marketing Collaboration Agreement with Biogen
Idec
In August 2000, we entered into a development and marketing
collaboration agreement with Biogen Idec, successor to Biogen,
Inc., to collaborate in the development and commercialization of
Tysabri for MS and CD, with Biogen Idec acting as the
lead party for MS and Elan acting as the lead party for CD.
In November 2004, Tysabri received regulatory approval in
the United States for the treatment of relapsing forms of MS. In
February 2005, Elan and Biogen Idec voluntarily suspended the
commercialization and dosing in clinical trials 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 Avonex in clinical trials.
These events involved two cases of PML, a rare and potentially
fatal, demyelinating disease of the central nervous system. Both
patients received more than two years of Tysabri therapy
in combination with Avonex. In March 2005, the companies
announced that their ongoing safety evaluation of Tysabri
led to a previously diagnosed case of malignant astrocytoma
being reassessed as PML, in a patient in an open label CD
clinical trial. The patient had received eight doses of
Tysabri over an
18-month
period. The patient died in December 2003.
A comprehensive safety evaluation was performed of more than
3,000 Tysabri patients in collaboration with leading
experts in PML and neurology. The results of the safety
evaluation yielded no new confirmed cases of PML beyond the
three previously reported.
In September 2005, Elan and Biogen Idec submitted to the FDA a
sBLA for Tysabri, which the FDA subsequently designated
for Priority Review. On March 7-8, 2006, the Peripheral Central
Nervous System Drug Advisory Committee reviewed and voted
unanimously to recommend that Tysabri be reintroduced as
a treatment for relapsing forms of MS.
In June 2006, the FDA approved the reintroduction of Tysabri
for the treatment of relapsing forms of MS. Approval for the
marketing of Tysabri in the European Union was also
received in June 2006 and has subsequently been received in a
number of other countries. The distribution of Tysabri in
both the United States and the ROW commenced in July 2006.
Global in-market net sales of Tysabri in 2007 were
$342.9 million (2006: $38.1 million; 2005:
$11.0 million), consisting of $217.4 million (2006:
$28.2 million; 2005: $11.0 million) in the United
States and $125.5 million (2006: $9.9 million; 2005:
$Nil) in the ROW.
Tysabri was developed and is now being marketed in
collaboration with Biogen Idec. In general, subject to certain
limitations imposed by the parties, we share with Biogen Idec
most development and commercialization costs. Biogen Idec is
responsible for manufacturing the product. In the United States,
we purchase Tysabri from Biogen Idec and are responsible
for distribution. Consequently, we record as revenue the net
sales of Tysabri in the U.S. market. We purchase
product from Biogen Idec as required at a price, which includes
the cost of manufacturing, plus Biogen Idec’s gross profit
on Tysabri and this cost, together with royalties payable
to other third parties, is included in cost of sales.
In the ROW market, Biogen Idec is responsible for distribution
and we record as revenue our share of the profit or loss on ROW
sales of Tysabri, plus our directly-incurred expenses on
these sales. In 2007, we recorded revenue of $14.3 million
(2006: negative $10.7 million; 2005: $Nil).
At December 31, 2007, we owed Biogen Idec
$25.0 million (2006: $42.9 million).
Under our collaboration agreement with Biogen Idec, if global
in-market net sales of Tysabri are, on average, for four
calendar quarters, in excess of $125 million per calendar
quarter, then we may elect to make a milestone payment to Biogen
Idec of $75 million in order to maintain our percentage
share of Tysabri at approximately 50% for annual global
in-market net sales of Tysabri that are in excess of
$700 million. Additionally, if we have made this first
milestone payment, then we may elect to pay a further
$50 million milestone to Biogen Idec if global in-market
net sales of Tysabri are, on average, for four calendar
quarters, in excess of $200 million per calendar quarter,
in order to maintain our percentage share of Tysabri at
approximately 50% for annual global in-market net sales of
Tysabri that are in excess of $1.1 billion. Should
we elect not to make the first milestone payment of
$75 million, then our percentage share of Tysabri
will be reduced to approximately 35% for annual global
in-market net sales of Tysabri exceeding
$700 million. If we elect to make the first milestone
payment, but not the second milestone
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payment, then our percentage share of Tysabri will be
reduced to approximately 35% for annual global in-market net
sales of Tysabri exceeding $1.1 billion.
This excerpt taken from the ELN 20-F filed Feb 28, 2007. Development
and Marketing Collaboration Agreement with Biogen
Idec
In August 2000, we entered into a development and marketing
collaboration agreement with Biogen Idec, successor to Biogen,
Inc., to collaborate in the development and commercialization of
Tysabri for MS and CD, with Biogen Idec acting as the
lead party for MS and Elan acting as the lead party for CD.
In November 2004, Tysabri received regulatory approval in
the United States for the treatment of relapsing forms of MS. In
February 2005, Elan and Biogen Idec voluntarily suspended the
commercialization and dosing in clinical trials 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 Avonex in clinical trials.
These events involved two cases of PML, a rare and potentially
fatal, demyelinating disease of the central nervous system. Both
patients received more than two years of Tysabri therapy
in combination with Avonex. In March 2005, the companies
announced that their ongoing safety evaluation of Tysabri
led to a previously diagnosed case of malignant astrocytoma
being reassessed as PML, in a patient in an open label CD
clinical trial. The patient had received eight doses of
Tysabri over an
18-month
period. The patient died in December 2003.
A comprehensive safety evaluation was performed of more than
3,000 Tysabri patients in collaboration with leading
experts in PML and neurology. The results of the safety
evaluation yielded no new confirmed cases of PML beyond the
three previously reported.
Table of Contents
In September 2005, Elan and Biogen Idec submitted to the FDA a
sBLA for Tysabri, which the FDA subsequently designated
for Priority Review. On March 7-8, 2006, the PCNS Advisory
Committee reviewed and voted unanimously to recommend that
Tysabri be reintroduced as a treatment for relapsing
forms of MS.
In June 2006, the FDA approved the re-introduction of Tysabri
for the treatment of relapsing forms of MS. Approval for the
marketing of Tysabri in the European Union was also
received in June 2006 and, in October 2006, approval was
received for the marketing of Tysabri in Canada. The
distribution of Tysabri in both the United States and the
European Union commenced in July 2006. Global in-market net
sales of Tysabri in 2006 were $38.1 million,
consisting of $28.2 million in the United States and
$9.9 million in the European Union.
Tysabri was developed and is now being marketed in
collaboration with Biogen Idec. In general, subject to certain
limitations imposed by the parties, we share with Biogen Idec
most development and commercialization costs. Biogen Idec is
responsible for manufacturing the product. In the United States,
we purchase Tysabri from Biogen Idec and are responsible
for distribution. Consequently, we record as revenue the net
sales of Tysabri in the US market. We purchase product
from Biogen Idec as required at a price, which includes the cost
of manufacturing, plus Biogen Idec’s gross profit on
Tysabri and this cost, together with royalties payable to
other third parties, is included in cost of sales. During 2006,
we recorded net sales of $28.2 million (2005:
$11.0 million) in the US market.
In the EU market, Biogen Idec is responsible for distribution
and we record as revenue our share of the profit or loss on EU
sales of Tysabri, plus our directly-incurred expenses on
these sales. In 2006, we recorded negative revenue of
$10.7 million (2005: $Nil).
At December 31, 2006, we owed Biogen Idec
$42.9 million (2005: $21.4 million).
Under our collaboration agreement with Biogen Idec, if global
in-market net sales of Tysabri are, on average, for four
calendar quarters, in excess of $125 million per calendar
quarter, then we may elect to make a milestone payment to Biogen
Idec of $75 million in order to maintain our percentage
share of Tysabri at approximately 50% for annual global
in-market net sales of Tysabri that are in excess of
$700 million. Additionally, if we have made this first
milestone payment, then we may elect to pay a further
$50 million milestone to Biogen Idec if global in-market
net sales of Tysabri are, on average, for four calendar
quarters, in excess of $200 million per calendar quarter,
in order to maintain our percentage share of Tysabri at
approximately 50% for annual global in-market net sales of
Tysabri that are in excess of $1.1 billion. Should
we elect not to make the first milestone payment of
$75 million, then our percentage share of Tysabri
will be reduced to approximately 35% for annual global
in-market net sales of Tysabri exceeding
$700 million. If we elect to make the first milestone
payment, but not the second milestone payment, then our
percentage share of Tysabri will be reduced to
approximately 35% for annual global in-market net sales of
Tysabri exceeding $1.1 billion.
This excerpt taken from the ELN 20-F filed Mar 30, 2006. Development
and Marketing Collaboration Agreement with Biogen
Idec
In August 2000, we entered into a development and marketing
collaboration agreement with Biogen Idec, successor to Biogen,
Inc., to collaborate in the development and commercialization of
Tysabri. Along with Biogen Idec, we are developing
Tysabri for MS and Crohn’s disease, with Biogen Idec
acting as the lead party for MS and Elan acting as the lead
party for Crohn’s disease.
In November 2004, Tysabri received regulatory approval in
the United States for the treatment of relapsing forms of MS.
Biogen Idec paid us a $7.0 million approval-based
milestone. The approval milestone payment, together with other
milestone payments related to the collaboration agreement of
$45.0 million, are recognized as revenue based on the
percentage-of-completion
method, which is based on the percentage of costs incurred to
date compared to the total costs expected under the contract.
Biogen Idec manufactures Tysabri. We purchase Tysabri
from Biogen Idec for distribution to third parties in the
United States. We recorded $11.0 million in product revenue
from Tysabri in 2005 (2004: $6.4 million). In
general, we share with Biogen Idec most development and
commercialization costs. At December 31, 2005, we owed
Biogen Idec $21.4 million (2004: $34.4 million) for
the reimbursement of costs related to development and
commercialization.
In February 2005, Elan and Biogen Idec voluntarily suspended the
marketing and dosing in clinical trials 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 Avonex in clinical trials. These events
involved two cases of PML, a rare and potentially fatal,
demyelinating disease of the central nervous system. Both
patients received more than two years of Tysabri therapy
in combination with Avonex. In March 2005, the companies
announced that their ongoing safety evaluation of Tysabri
led to a previously diagnosed case of malignant astrocytoma
being reassessed as PML, in a patient in an open label
Crohn’s disease clinical trial. The patient had received
eight doses of Tysabri over an
18-month
period. The patient died in December 2003.
Elan and Biogen Idec performed a comprehensive safety evaluation
of more than 3,000 Tysabri patients in collaboration with
leading experts in PML and neurology. The results of the safety
evaluation yielded 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 March 7-8, 2006, the PCNS Advisory
Committee reviewed and voted unanimously to recommend that
Tysabri be reintroduced as a treatment for relapsing
forms of 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.
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