Genzyme Wins FDA Approval of Mozobil

Xconomy Boston — 

Genzyme won FDA approval today of a new drug for patients with blood cancers. The Cambridge, MA-based biotech company (NASDAQ: GENZ) said it has gotten clearance to sell plerixafor (Mozobil) as an injectable drug for patients with a pair of deadly blood malignancies, non-Hodgkin’s lymphoma and multiple myeloma, who need transplants of blood-forming stem cells.

The product is meant to be used to aid so-called “autologous” transplants—in which patients’ own cells are collected and stored for later transplantation—by helping to coax the blood-forming stem cells from the bone marrow into the bloodstream, where they can be collected. The new drug is approved for use in conjunction with a drug called granulocyte-colony stimulating factor (G-CSF), marketed by Amgen as pegfilgrastim (Neupogen). The combination of the Genzyme and Amgen drugs is supposed to boost the speed and efficiency of stem-cell collection over the Amgen drug alone.

“Mozobil is an important advancement in the treatment of patients with certain types of cancer who require a stem cell transplant,” said John F. DiPersio, a professor at Washington University in St. Louis, in a company statement. “This product should become an integral part of the treatment regimen for transplantation.”

The approval was expected by investors, according to Thomas Shrader, an analyst with Rodman & Renshaw in New York. The new Genzyme product should generate about $75 million in sales in 2009, its first full year on the market, Shrader said. Genzyme has applied for approval of the product in Europe, and expects approval in the second half of 2009, the company said. Genzyme acquired the drug through its purchase of Vancouver, BC-based AnorMed for $580 million in 2006.