which has been constrained by limited product supply, as the FDA has
yet to approve the larger scale manufacturing process for this product.
This supply constraint will have an estimated impact of $0.03 per
diluted share during the first quarter.
-- Sales of Myozyme are expected to increase to $320-$330 million this
year, compared with $201 million last year. The launch of this product
has been the most rapid for any of Genzyme's lysosomal storage disorder
treatments. In December, Genzyme announced that its post-marketing
Late-Onset Treatment Study of Myozyme met its co-primary endpoints,
confirming the benefit of the product for patients across the spectrum
of Pompe disease. The company has begun submitting the results of this
study for presentation at medical meetings and will pursue the
inclusion of the trial results in the product's labeling.
-- Sales of Fabrazyme(R) (agalsidase beta) are expected to reach $495-$505
million this year, compared with $424 million in 2007. The European
Commission has granted full marketing authorization for Fabrazyme,
making the product the only Fabry disease treatment to earn this
designation in Europe.
-- Sales of Cerezyme(R) (imiglucerase for injection) are expected to reach
$1.22-$1.24 billion this year, compared with $1.13 billion in 2007.
-- Sales of sevelamer therapies Renagel(R) (sevelamer hydrochloride) and
Renvela(R) (sevelamer carbonate) are expected to rise to $690-$700
million this year, compared with $603 million in 2007. Renvela was
approved by the FDA in October for the treatment of hemodialysis
patients, and Genzyme plans to launch the product on March 1. Genzyme
is currently engaged in active discussions with the FDA to expand the
|SOURCE Genzyme Corporation|
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