Genzyme continues to expect non-GAAP earnings for this year of approximately $3.90 per diluted share. GAAP earnings in 2008 are expected to be approximately $2.20 per diluted share. The GAAP estimate now reflects Genzyme's equity investment in Isis Pharmaceuticals, the mipomersen licensing fee, along with anticipated amortization, stock-compensation expenses and the effect of contingent convertible debt.
Second-Quarter Product Sales
Within the Therapeutics business, Myozyme revenue rose 65 percent compared with last year's second quarter, despite the constraint on U.S. sales resulting from the delay in approval of 2000L-scale production. Revenue increased to $77.2 million from $46.7 million in the same period a year ago. The FDA is expected to convene an advisory committee meeting in October to discuss the BLA for alglucosidase alfa produced at the 2000L-scale, as required for all new drug and biologics license applications under the FDA Amendments Act enacted last year. FDA approval of 2000L-scale production is needed to provide broader access to product for adult patients in the United States.
The launch of Myozyme has been more rapid than the launch of any of
Genzyme's other treatments for lysosomal storage disorders, driven by
faster than expected adoption by physicians and patients and consistent
support from health authorities in more than 40 countries. To meet the
global demand for Myozyme, Genzyme is working to secure approval of
production at its 4000L bioreactor scale manufacturing plant in Belgium,
which would significantly expand capacity. The company is conducting
process validation runs for Myozyme produced at the 4000L-scale, which it
expects to complete this year and subsequently file for EMEA approval. The
company expects that European authorities will approve Myozyme production
at the facility during the first half of 2009. Approval of 4000L-scale
production in Belgium will be necessary to meet the ant
|SOURCE Genzyme Corporation|
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