Over the next 12 months, Genzyme anticipates six potential approvals for new products or broader indications for existing products. These catalysts will provide significant near term momentum:
-- Genzyme expects FDA approval by the end of this year for alglucosidase alfa (Myozyme(R)) produced at the 2000L bioreactor scale, following the submission of a BLA on May 30. European approval of Myozyme produced at the 4000L scale is expected in the first half of next year.
-- The company anticipates that the labeling for Renvela(R) (sevelamer carbonate) will be expanded by mid-2009 to include the treatment of chronic kidney disease patients with elevated phosphorus levels who are not on dialysis. Genzyme, along with two other companies, submitted a position paper to the FDA in May regarding this expanded use of phosphate binders.
-- Genzyme also expects that the labeling for Clolar(R) (clofarabine) will be expanded by the middle of next year to include its use in treating adult patients with acute myelogenous leukemia. The company plans to file supplemental marketing applications this year to broaden Clolar's indication.
-- Genzyme expects to launch Mozobil(TM) (plerixafor) in the United States and Europe during the first half of next year, following regulatory approval. The company submitted marketing applications for the product last month. Mozobil is intended to enable patients with certain types of cancers to successfully receive a stem-cell transplantation.
-- FDA action on Genzyme's marketing application for Synvisc-ONE(R)
(hylan G-F 20) is anticipated this year. The company submitted a response
to the agency in June that included additional analysis and data requested
in a Nov
|SOURCE Genzyme Corporation|
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