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This excerpt taken from the ELN 20-F filed Feb 28, 2007. Dr. Garo
Armen
In relation to Dr. Armen’s retirement from the board
on May 25, 2006, we agreed to vest on his retirement 25,000
options that would otherwise have expired unvested on his
retirement date, and extended the exercise term of 50,000
options from ninety days to one year post-retirement.
This excerpt taken from the ELN 20-F filed Mar 30, 2006. Dr.
Garo Armen
In relation to Dr. Garo Armen’s retirement from the board,
we have agreed to vest on his retirement 25,000 options that
would otherwise have expired unvested on his retirement date,
and have extended the exercise term of 50,000 options from
ninety days to one year post-retirement.
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 multiple sclerosis (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.
Subsequent to the voluntary suspension, 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, which
was completed in September 2005, identified no new confirmed
cases of PML beyond the three previously reported.
In September 2005, Elan and Biogen Idec submitted to the 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 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.
Table of Contents
Elan
Corporation, plc
NOTES TO
THE CONSOLIDATED FINANCIAL
STATEMENTS — (Continued)
Our business is organized into two business units:
Biopharmaceuticals and EDT. Biopharmaceuticals engages in
research, development and commercial activities and includes our
activities in the areas of autoimmune diseases,
neurodegenerative diseases and our specialty business group. EDT
focuses on product development,
scale-up and
manufacturing to address drug optimization challenges of the
pharmaceutical industry.
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