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results by mid year for a larger number of patients, including results
for those patients who have completed the one year trial. Final
results for all trial participants will be available in the first
quarter of 2009. Genzyme is currently developing clinical trial
protocols for two Phase 3 studies of Genz-112638, and the company
anticipates initiating these studies early next year. Genzyme believes
that this oral product may offer a more convenient treatment option for
some patients.
Mipomersen for high-risk cardiovascular disease
Genzyme expects to finalize its license of mipomersen from Isis
Pharmaceuticals in the second quarter and subsequently communicate a
development plan for the product. Mipomersen is a lipid-lowering agent
being developed primarily for patients at significant cardiovascular
risk who are unable to achieve target cholesterol levels with statins
alone or who are intolerant of statins. The product offers an
innovative approach to addressing a serious unmet medical need, and
Genzyme believes it could prove to be the most effective lipid-lowering
agent for high risk cardiovascular disease patients for whom
conventional therapies are not sufficient. The product may provide
significant benefit over the standard of care and targets a well-defined
and severely ill patient population. Mipomersen is currently being
studied in a Phase 3 clinical trial involving patients with homozygous
familial hypercholesterolemia.
This press release contains forward-looking statements regarding
Genzyme's financial outlook and business plans and strategies, including
without limitation: its Q2 2008, YE 2008 and YE 20011 earnings guidance;
its anticipated CAGR through 2011; its expectations for approval of Myo
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