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This excerpt taken from the ELN 6-K filed Mar 30, 2009. 28 Development
and Marketing Collaboration Agreements
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 commercialisation of
Tysabri for multiple sclerosis and Crohn’s disease,
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
commercialisation 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
progressive multifocal leukoencephalopathy (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 of more than 3,000 Tysabri
patients was performed 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.
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 7-8 March
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 European Union commenced in July
2006. Global in-market net sales of Tysabri in 2008 were
$813.0 million (2007: $342.9 million), consisting of
$421.6 million (2007: $217.4 million) in the
U.S. market and $391.4 million (2007:
$125.5 million) in the rest of world (ROW).
On 14 January 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 12 December 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.
Table of Contents
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 commercialisation costs for Tysabri.
Biogen Idec is responsible for manufacturing the product. In the
United States, we purchase Tysabri from Biogen Idec and
are responsible for distribution. Outside of the United States,
Biogen Idec is responsible for distribution.
The Tysabri collaboration is a jointly controlled
operation in accordance with IAS 31. A jointly controlled
operation is an operation of a joint venture that involves the
use of the assets and other resources of the venturers rather
than establishing a corporation, partnership or other entity, or
a financial structure that is separate from the venturers
themselves. Each venturer uses its own property, plant and
equipment and carries its own inventories. It also incurs its
own expenses and liabilities and raises its own finances, which
represent its own obligations.
Our actual operating profit or loss on Tysabri differs
from our share of the collaboration operating profit or loss,
because certain Tysabri-related expenses are not shared
through the collaboration and certain unique risks are retained
by each party.
The Tysabri collaboration operating profit or loss is
calculated excluding R&D expenses (we record our share of
the total Tysabri collaboration R&D expenses within
our R&D expenses). In accordance with IAS 31, in any period
where an operating loss has been incurred by the collaboration
on sales of Tysabri, we do not recognise any Tysabri
product revenue. In any period where an operating profit has
been generated by the collaboration on sales of Tysabri,
we recognise as revenue our share of the collaboration profit
from sales of Tysabri, plus our directly incurred
collaboration expenses on these sales.
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
31 December 2008. The intangible assets have been and will
be amortised on a straight-line basis over approximately
11 years. There are no further milestone payments required
for us to retain our approximate 50% profit share.
For additional information relating to Tysabri, refer to
Note 3.
Wyeth
In March 2000, we entered into a research, development and
commercialisation collaboration agreement with Wyeth, successor
to American Home Products, Inc., to collaborate in the research,
development and commercialisation of beta amyloid
immunotherapies, including bapineuzumab, and ACC-001, a novel
beta amyloid immunoconjugate, for the treatment and prevention
of some neurodegenerative conditions in humans.
In May 2007, Elan and Wyeth announced their decision to initiate
a Phase 3 clinical programme for bapineuzumab. The Phase 3
programme encompasses studies in North America and the ROW. In
December 2007, we announced that the first patient had been
dosed in the studies taking place in North America. ROW studies
began enrolling patients during the second half of 2008. We are
responsible for conducting the studies in North America, while
Wyeth is responsible for conducting the studies in the ROW.
The Phase 3 programme includes four randomised, double-blind,
placebo controlled studies across two subpopulations, which are
designed to total approximately 4,000 patients with mild to
moderate AD at approximately 350 sites. The treatment duration
for each patient is 18 months with patients intended to be
equally distributed between North America and the ROW. The
studies stratify patients by ApoE4 genotype, and all studies
have co-primary efficacy end points—one cognitive and one
functional.
Under our collaboration with Wyeth, in general, subject to
certain limitations imposed by the parties, we share most of the
research, development, and commercialisation costs. We are
responsible for the manufacture and supply of products, while
Wyeth is responsible for distribution. We continue to discuss
with Wyeth a joint commercialisation plan. We are eligible to
earn milestone payments from Wyeth for such events as first
regulatory approval filings and product approvals and achieving
a certain sales level.
Table of Contents
Notes to the
Consolidated Financial Statements
Transition
Therapeutics
In September 2006, we entered into an exclusive, worldwide
collaboration with Transition Therapeutics, Inc. (Transition)
for the joint development and commercialisation of a novel
therapeutic agent for Alzheimer’s disease. The small
molecule, ELND005, is a beta amyloid anti-aggregation agent that
has been granted fast track designation by the FDA. In December
2007, the first patient was dosed in a Phase 2 clinical study.
This
18-month,
randomised, double-blind, placebo-controlled, dose-ranging study
will evaluate the safety and efficacy of ELND005 in
approximately 340 patients with mild to moderate
Alzheimer’s disease. The patient enrollment target for this
study was achieved in October 2008.
Under our collaboration with Transition, we shall make a
$25.0 million milestone payment to Transition after the
initiation of the first Phase 3 clinical trial for ELND005.
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