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to rise to approximately $7.00 per diluted share by 2011.
-- Myozyme sales are expected to be approximately $275-$285 million this
year, compared to prior guidance of $320-$330 million.
-- Non-GAAP earnings per share for the second quarter are expected to be
in the mid $0.90s, reflecting ongoing investments to drive future
growth. These include investments in the U.S. launch of Renvela(R)
(sevelamer carbonate) and the expanded European introduction of
Clolar(R) (clofarabine), as well as investments in late-stage clinical
trials-particularly the phase 3 study of alemtuzumab for multiple
sclerosis. This estimate also reflects the constraints on U.S. Myozyme
sales.
First-Quarter Product Sales
-- Within the Therapeutics business, worldwide demand for Myozyme remains
robust two years into the product's launch. First-quarter sales rose
78 percent despite the delay in U.S. approval for 2000L production
capacity. Sales increased to $67.3 million from $37.9 million in the
period a year ago, driven by the number of new patients starting
therapy. As announced, the FDA will require Genzyme to submit a BLA to
obtain U.S. commercial approval for Myozyme produced at the 2000L
scale. The agency is expected to act on the application by the end of
this year.
-- First-quarter sales of Cerezyme(R) (imiglucerase for injection) rose 15
percent to $304.3 million, compared with $263.8 million in the previous
first quarter.
-- Sales of Fabrazyme(R) (agalsidase beta) grew 16 percent in the quarter,
rising to $116.5 million from $100.7 million in the first quarter last
year. Fabrazyme has captured more than a two thirds share of the
international market for Fabry disease treatment based on compelling
clinical dat
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| SOURCE Genzyme Corp. Copyright©2008 PR Newswire. All rights reserved |