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This excerpt taken from the ELN 6-K filed Mar 30, 2009. 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
This excerpt taken from the ELN 20-F filed Feb 26, 2009. Wyeth
In March 2000, we entered into a research, development and
commercialization collaboration agreement with Wyeth, successor
to American Home Products, Inc., to collaborate in the research,
development and commercialization 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.
Table of Contents
Elan
Corporation, plc
NOTES TO
THE CONSOLIDATED FINANCIAL
STATEMENTS — (Continued)
In May 2007, Elan and Wyeth announced their decision to initiate
a Phase 3 clinical program for bapineuzumab. The Phase 3 program
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 program includes four randomized, double-blinded,
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 commercialization 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 commercialization 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.
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