American Society of Clinical Oncology meeting in June.
Genzyme is developing a new filing for the adult AML indication in
Europe. This follows its withdrawal of Bioenvision's marketing
application, which, as expected, an advisory committee deemed
insufficient to support approval. Genzyme expects to make a new
submission as early as the fourth quarter of this year that will
include a more robust data package from Genzyme sponsored studies.
Alemtuzumab for multiple sclerosis
-- Final, three-year efficacy and safety data from the Phase 2 trial
comparing alemtuzumab with Rebif (interferon beta-1a) for the treatment
of relapsing-remitting multiple sclerosis were presented last week
during a scientific platform session at the American Academy of
Neurology meeting by Dr. Alasdair Coles. These results confirm all
trends observed in the one- and two-year interim analyses. The two
ongoing Phase 3 trials further examining the efficacy and safety of
alemtuzumab for the treatment of MS are progressing. These two studies
are currently enrolling patients at sites in the United States, Europe,
Latin America and Australia. Genzyme believes that alemtuzumab has the
potential to be the best therapy in a market for MS drugs that is
projected to reach $8-9 billion annually when the treatment is expected
to be ready for launch in 2011-2012. Alemtuzumab is being developed in
collaboration with Bayer Schering Pharma AG, Germany.
Genz-112638 for Gaucher disease
-- Genzyme is making excellent progress in developing the small molecule
Genz-112638, a novel oral therapy intended for the treatment of Gaucher
disease. Initial results released one year ago for the first group of
|SOURCE Genzyme Corp.|
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